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CompletedNCT01704495NIMBUSUpdated Mar 1, 2016Results posted

A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.

A Phase 2 interventional study of AZD5069 and Placebo in Asthma, sponsored by AstraZeneca. Completed at 99 sites in 13 countries. Open to participants aged 18 Years to 150 Years. Per ClinicalTrials.gov, last updated 2016-03-01.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
1,147
Allocation
Randomized
Ages
18 Years to 150 Years
Sex
All
01

Study summary

The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

Read the detailed description

A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

02

Conditions studied

  • Asthma

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Keywords

  • Uncontrolled Asthma,
  • Exacerbation,
  • Safety
03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 1,147 is above the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 150 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner.
  • Diagnosis of asthma for at least 12 months (GINA 2011)
  • Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
  • Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment
  • Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)

Exclusion criteria

Exclusion Criteria:

  • Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results
  • Patients with recurrent, latent, or chronic infections
  • Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
  • Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
  • Current smoker or smoking history of more than 20 pack years
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,147 participants (actual)

Study arms

  • Experimental
    AZD5069 5 mg

    AZD5069 oral capsules self-administered twice daily

    Drug: AZD5069

  • Experimental
    AZD5069 15 mg

    AZD5069 oral capsules self-administered twice daily

    Drug: AZD5069

  • Experimental
    AZD5069 45 mg

    AZD5069 oral capsules self-administered twice daily

    Drug: AZD5069

  • Placebo comparator
    Placebo

    Placebo oral capsules self-administered twice daily

    Drug: Placebo

Interventions

  • DrugAZD5069

    AZD5069 oral capsules self-administered twice daily.

  • DrugPlacebo

    Placebo oral capsules self-administered twice daily.

06

What researchers measure

Primary outcomes

  1. Rate of Severe Asthma Exacerbations During 6 Months

    Time frame: From start of treatment up to 6 months

Secondary outcomes

  1. Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months

    Time frame: From start of treatment up to 6 months

  2. Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions

    Time frame: From start of treatment up to 6 months

  3. Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms

    Time frame: From start of treatment up to 6 months

  4. Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis

    Time frame: Baseline (Day 0) and 2 weeks after Day 0

  5. Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at one month are included in the analysis

    Time frame: Baseline (Day 0) and 1 month after Day 0

  6. Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at two months are included in the analysis

    Time frame: Baseline (Day 0) and 2 months after Day 0

  7. Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at three months are included in the analysis

    Time frame: Baseline (Day 0) and 3 months after Day 0

  8. Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at four months are included in the analysis

    Time frame: Baseline (Day 0) and 4 months after Day 0

  9. Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at six months are included in the analysis

    Time frame: Baseline (Day 0) and 6 months after Day 0

  10. Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis

    Time frame: Baseline (Day 0) and 2 weeks after Day 0

  11. Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at one month are included in the analysis

    Time frame: Baseline (Day 0) and 1 month after Day 0

  12. Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at two months are included in the analysis

    Time frame: Baseline (Day 0) and 2 months after Day 0

  13. Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at three months are included in the analysis

    Time frame: Baseline (Day 0) and 3 months after Day 0

  14. Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at four months are included in the analysis

    Time frame: Baseline (Day 0) and 4 months after Day 0

  15. Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1

    Only patients with both a non-missing value at baseline and visit at six months are included in the analysis

    Time frame: Baseline (Day 0) and 6 months after Day 0

  16. Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score

    The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

    Time frame: Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)

  17. Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)

    The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

    Time frame: Baseline (Day 0) and 6 months after Day 0

  18. Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score

    The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

    Time frame: Baseline (Day 0), Treatment Period (1,3, and 6 months)

  19. Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score

    The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

    Time frame: Baseline (Day 0) and 6 months after Day 0

  20. Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)

  21. Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)

  22. Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)

  23. Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)

  24. Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)

  25. Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)

  26. Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)

  27. Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months

  28. Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)

  29. Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)

  30. Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)

  31. Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)

  32. Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)

  33. Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)

  34. Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)

  35. Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms

    Time frame: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)

  36. Number of Participants With Well Controlled Asthma Weeks at Baseline

    Time frame: Last 2 weeks before randomization

  37. Number of Well Controlled Asthma Weeks During Treatment

    Time frame: Day 1to end of the 6 months treatment period

  38. Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline

    Time frame: Last 2 weeks before randomization

  39. Number of Uncontrolled Persistent Asthma Weeks During Treatment

    Time frame: Day 1 to end of the 6 months treatment period

  40. Mean Plasma Concentration of AZD5069 at Day 7

    Time frame: Day 7

  41. Mean Plasma Concentration of AZD5069 at 1 Month

    Time frame: at 1 month

07

Results

Posted Mar 1, 2016

Participant flow

6 months double-blind study with optional safety extension for up to 6 months, were subjects continued on the treatment they were randomized to. First subject enrolled 27 Nov 2012 Last subject last visit 27 Aug 2014 1146 subjects enrolled in tot of which 506 patients were not randomized since they did not fulfilled all the inclusion conditions.

Subjects Randomized
Participant flow — Subjects Randomized
MilestoneAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Started162156160162
Completed140141144145
Not completed22151617
Withdrew: Other reason3232
Withdrew: Discontinuation criteria met4220
Withdrew: Adverse event8207
Withdrew: Withdrawal by subject5555
Withdrew: Protocol violation1120
Withdrew: Eligibility criteria not fulfilled1343
Optional Safety Extension
Participant flow — Optional Safety Extension
MilestoneAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Started116121114116
Completed87888385
Not completed29333131
Withdrew: Adverse event0401
Withdrew: Other reason27293028
Withdrew: Withdrawal by subject2012

Outcome measures

PrimaryRate of Severe Asthma Exacerbations During 6 Months
Time frame:
From start of treatment up to 6 months
Reported as:
Least squares mean · Exacerbations per 6 month
Rate of Severe Asthma Exacerbations During 6 Months
Exacerbations per 6 monthAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Rate of Severe Asthma Exacerbations During 6 Months0.31 (0.20 to 0.50)0.31 (0.19 to 0.49)0.26 (0.16 to 0.42)0.20 (0.12 to 0.33)
Statistical analysis
  • AZD5069 45 mg BID vs Placebo · Poisson regression · p = 0.119 (2-sided p-value) · Risk ratio (rr): 1.56 · 90% CI 0.98 to 2.49AZD5069 45 mg BID vs Placebo
  • AZD5069 15 mg BID vs Placebo · Poisson Regression · p = 0.141 (2-sided) · Risk ratio (rr): 1.53 · 90% CI 0.95 to 2.46AZD5069 15 mg BID vs Placebo
  • AZD5069 5 mg BID vs Placebo · Poisson Regression · p = 0.397 (2-sided) · Risk ratio (rr): 1.29 · 90% CI 0.79 to 2.11AZD5069 5 mg BID vs Placebo
SecondaryRate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months
Time frame:
From start of treatment up to 6 months
Reported as:
Least squares mean · Exacerbations per 6 month
Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months
Exacerbations per 6 monthAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months0.04 (0.01 to 0.14)0.02 (0.00 to 0.09)0.02 (0.02 to 0.09)0.02 (0.01 to 0.09)
SecondaryTotal Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions
Time frame:
From start of treatment up to 6 months
Reported as:
Least squares mean · Days
Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions
DaysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions0.54 (0.26 to 1.12)0.82 (0.38 to 1.77)0.00 (0.00 to 0.01)0.08 (0.03 to 0.23)
SecondaryTotal Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms
Time frame:
From start of treatment up to 6 months
Reported as:
Least squares mean · Days
Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms
DaysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms2.38 (1.33 to 4.26)2.43 (1.33 to 4.45)2.74 (1.42 to 5.29)1.55 (0.80 to 3.00)
SecondaryChange From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis

Time frame:
Baseline (Day 0) and 2 weeks after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV10.13 (0.06 to 0.20)0.07 (0.00 to 0.14)0.09 (0.02 to 0.16)0.12 (0.05 to 0.19)
SecondaryChange From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at one month are included in the analysis

Time frame:
Baseline (Day 0) and 1 month after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV10.14 (0.07 to 0.21)0.08 (0.01 to 0.16)0.09 (0.02 to 0.16)0.09 (0.02 to 0.16)
SecondaryChange From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two months are included in the analysis

Time frame:
Baseline (Day 0) and 2 months after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV10.13 (0.06 to 0.20)0.08 (0.01 to 0.16)0.07 (-0.01 to 0.14)0.12 (0.05 to 0.19)
SecondaryChange From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at three months are included in the analysis

Time frame:
Baseline (Day 0) and 3 months after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV10.10 (0.03 to 0.18)0.11 (0.04 to 0.18)0.06 (-0.02 to 0.13)0.06 (-0.01 to 0.13)
SecondaryChange From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at four months are included in the analysis

Time frame:
Baseline (Day 0) and 4 months after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV10.17 (0.09 to 0.24)0.17 (0.09 to 0.24)0.14 (0.06 to 0.21)0.16 (0.08 to 0.23)
SecondaryChange From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at six months are included in the analysis

Time frame:
Baseline (Day 0) and 6 months after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV10.14 (0.06 to 0.21)0.09 (0.01 to 0.16)0.10 (0.03 to 0.18)0.11 (0.04 to 0.18)
SecondaryChange From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis

Time frame:
Baseline (Day 0) and 2 weeks after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV10.06 (0.01 to 0.11)0.05 (-0.01 to 0.10)0.03 (-0.02 to 0.09)0.03 (-0.02 to 0.09)
SecondaryChange From Baseline to 1 Month Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at one month are included in the analysis

Time frame:
Baseline (Day 0) and 1 month after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV10.06 (0.01 to 0.12)0.05 (0.00 to 0.11)0.03 (-0.03 to 0.09)0.03 (-0.03 to 0.08)
SecondaryChange From Baseline to 2 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at two months are included in the analysis

Time frame:
Baseline (Day 0) and 2 months after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV10.03 (-0.02 to 0.09)0.04 (-0.02 to 0.10)0.01 (-0.05 to 0.07)0.02 (-0.04 to 0.08)
SecondaryChange From Baseline to 3 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at three months are included in the analysis

Time frame:
Baseline (Day 0) and 3 months after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV10.04 (-0.02 to 0.10)0.04 (-0.02 to 0.10)-0.00 (-0.06 to 0.06)-0.01 (-0.07 to 0.05)
SecondaryChange From Baseline to 4 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at four months are included in the analysis

Time frame:
Baseline (Day 0) and 4 months after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV10.06 (-0.00 to 0.12)0.06 (0.00 to 0.13)0.03 (-0.03 to 0.10)0.03 (-0.03 to 0.10)
SecondaryChange From Baseline to 6 Months Measurement of Post-bronchodilator FEV1

Only patients with both a non-missing value at baseline and visit at six months are included in the analysis

Time frame:
Baseline (Day 0) and 6 months after Day 0
Reported as:
Least squares mean · L
Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1
LAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV10.06 (0.01 to 0.12)0.02 (-0.03 to 0.08)0.04 (-0.02 to 0.10)-0.01 (-0.07 to 0.05)
SecondaryChange From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score

The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

Time frame:
Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)
Reported as:
Least squares mean · Units on a scale]
Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score
Units on a scale]AZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score-0.68 (-0.83 to -0.52)-0.66 (-0.82 to -0.51)-0.64 (-0.80 to -0.48)-0.70 (-0.86 to -0.55)
SecondaryNumber of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)

The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

Time frame:
Baseline (Day 0) and 6 months after Day 0
Reported as:
Number · Participants with improvement
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)
Participants with improvementAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)72887369
SecondaryChange From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score

The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

Time frame:
Baseline (Day 0), Treatment Period (1,3, and 6 months)
Reported as:
Least squares mean · Overall Score
Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score
Overall ScoreAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score0.50 (0.36 to 0.65)0.46 (0.31 to 0.61)0.52 (0.37 to 0.67)0.52 (0.38 to 0.67)
SecondaryNumber of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score

The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and \> 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

Time frame:
Baseline (Day 0) and 6 months after Day 0
Reported as:
Number · Participants with improvement
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score
Participants with improvementAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score62686962
SecondaryChange From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
Reported as:
Least squares mean · Asthma symptom free days
Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days
Asthma symptom free daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days-0.4 (-3.4 to 2.7)1.6 (-1.5 to 4.6)1.2 (-2.0 to 4.3)1.1 (-1.9 to 4.1)
SecondaryChange From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)
Reported as:
Least squares mean · symptom free days
Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days
symptom free daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days0.2 (-4.3 to 4.7)2.6 (-2.0 to 7.1)3.4 (-1.2 to 8.1)3.1 (-1.4 to 7.6)
SecondaryChange From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)
Reported as:
Least squares mean · symptom free days
Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days
symptom free daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days1.4 (-3.4 to 6.3)4.3 (-0.6 to 9.3)3.0 (-2.1 to 8.0)4.0 (-0.9 to 8.9)
SecondaryChange From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)
Reported as:
Least squares mean · symptom free days
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days
symptom free daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days2.6 (-2.5 to 7.8)5.6 (0.5 to 10.7)3.9 (-1.3 to 9.2)4.4 (-0.7 to 9.5)
SecondaryChange From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
Reported as:
Least squares mean · asthma control days
Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days
asthma control daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days-1.1 (-3.9 to 1.6)1.7 (-1.1 to 4.6)1.2 (-1.7 to 4.1)0.9 (-1.8 to 3.7)
SecondaryChange From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)
Reported as:
Least squares mean · asthma control days
Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days
asthma control daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days-0.1 (-4.2 to 4.0)3.5 (-0.7 to 7.7)2.7 (-4.2 to 4.0)2.8 (-1.4 to 6.9)
SecondaryChange From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)
Reported as:
Least squares mean · asthma control days
Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days
asthma control daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days0.9 (-3.8 to 5.6)4.7 (-0.0 to 9.4)3.2 (-1.6 to 8.1)2.9 (-1.8 to 7.6)
SecondaryChange From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months
Reported as:
Least squares mean · asthma control days
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days
asthma control daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days1.4 (-3.4 to 6.2)5.7 (0.9 to 10.5)3.9 (-1.0 to 8.8)2.4 (-2.3 to 7.2)
SecondaryChange From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
Reported as:
Least squares mean · rescue medication free days
Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days
rescue medication free daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days4.0 (-0.6 to 8.6)8.3 (3.6 to 13.0)6.8 (2.0 to 11.5)9.5 (4.9 to 14.1)
SecondaryChange From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)
Reported as:
Least squares mean · rescue medication free days
Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days
rescue medication free daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days10.7 (4.6 to 16.8)17.6 (11.4 to 23.8)15.4 (9.1 to 21.8)16.4 (10.3 to 22.6)
SecondaryChange From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)
Reported as:
Least squares mean · rescue medication free days
Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days
rescue medication free daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days12.3 (5.7 to 18.9)19.2 (12.6 to 25.9)19.8 (13.0 to 26.6)18.7 (12.1 to 25.3)
SecondaryChange From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)
Reported as:
Least squares mean · rescue medication free days
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days
rescue medication free daysAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days15.8 (9.0 to 22.7)23.1 (16.2 to 29.9)21.2 (14.2 to 28.2)20.0 (13.2 to 26.8)
SecondaryChange From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
Reported as:
Least squares mean · night time awakenings
Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms
night time awakeningsAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms-10.1 (-14.6 to -5.5)-11.1 (-15.7 to -6.5)-11.3 (-16.0 to -6.6)-8.9 (-13.4 to -4.3)
SecondaryChange From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)
Reported as:
Least squares mean · night time awakenings
Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms
night time awakeningsAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms-15.2 (-20.7 to -9.8)-19.0 (-24.5 to -13.5)-18.2 (-23.8 to -12.6)-15.2 (-20.7 to -9.7)
SecondaryChange From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)
Reported as:
Least squares mean · night time awakenings
Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms
night time awakeningsAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms-17.6 (-23.2 to -11.9)-19.8 (-25.5 to -14.0)-22.1 (-27.9 to -16.2)-16.7 (-22.4 to -11.0)
SecondaryChange From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms
Time frame:
Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)
Reported as:
Least squares mean · night time awakenings
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms
night time awakeningsAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms-22.8 (-28.7 to -17.0)-25.5 (-31.3 to -19.6)-25.3 (-31.3 to -19.3)-21.8 (-27.7 to -16.0)
SecondaryNumber of Participants With Well Controlled Asthma Weeks at Baseline
Time frame:
Last 2 weeks before randomization
Reported as:
Number · participants
Number of Participants With Well Controlled Asthma Weeks at Baseline
participantsAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
0 Well-controlled asthma weeks Baseline154152150152
1 Well-controlled asthma weeks Baseline6147
2 Well-controlled asthma weeks Baseline0020
SecondaryNumber of Well Controlled Asthma Weeks During Treatment
Time frame:
Day 1to end of the 6 months treatment period
Reported as:
Mean · well controlled asthma weeks
Number of Well Controlled Asthma Weeks During Treatment
well controlled asthma weeksAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Number of Well Controlled Asthma Weeks During Treatment1.7 ± 4.381.9 ± 4.782.4 ± 5.382.3 ± 5.27
SecondaryNumber of Participants With Uncontrolled Persistent Asthma Weeks at Baseline
Time frame:
Last 2 weeks before randomization
Reported as:
Number · participants
Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline
participantsAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
0 uncontrolled persistent asthma weeks23182627
1 uncontrolled persistent asthma weeks40393436
2 uncontrolled persistent asthma weeks97969695
SecondaryNumber of Uncontrolled Persistent Asthma Weeks During Treatment
Time frame:
Day 1 to end of the 6 months treatment period
Reported as:
Mean · uncontrolled persistent asthma weeks
Number of Uncontrolled Persistent Asthma Weeks During Treatment
uncontrolled persistent asthma weeksAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Number of Uncontrolled Persistent Asthma Weeks During Treatment11.0 ± 10.010.7 ± 10.0210.4 ± 9.8410.9 ± 9.89
SecondaryMean Plasma Concentration of AZD5069 at Day 7
Time frame:
Day 7
Reported as:
Geometric mean · (nmol/L)
Mean Plasma Concentration of AZD5069 at Day 7
(nmol/L)AZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Mean Plasma Concentration of AZD5069 at Day 7235.0 ± 1525.4969.9 ± 717.8325.4 ± 511.02—
SecondaryMean Plasma Concentration of AZD5069 at 1 Month
Time frame:
at 1 month
Reported as:
Geometric mean · (nmol/L)
Mean Plasma Concentration of AZD5069 at 1 Month
(nmol/L)AZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
Mean Plasma Concentration of AZD5069 at 1 Month152.2 ± 11200.6476.4 ± 788.1725.8 ± 449.02—

Adverse events

Collected over 12 months. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AZD5069 45 mg BID—14/161 (8.7%)86/161 (53.4%)
AZD5069 15 mg BID—8/153 (5.2%)68/153 (44.4%)
AZD5069 5 mg BID—7/156 (4.5%)74/156 (47.4%)
Placebo—13/159 (8.2%)96/159 (60.4%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
ASTHMARespiratory, thoracic and mediastinal disorders4/1613/1534/1563/159
PNEUMONIAInfections and infestations3/1611/1530/1562/159
ATRIAL FIBRILLATIONCardiac disorders1/1610/1530/1562/159
HELICOBACTER GASTRITISInfections and infestations0/1611/1530/1560/159
SALMONELLOSISInfections and infestations0/1611/1530/1560/159
STREPTOCOCCAL SEPSISInfections and infestations0/1611/1530/1560/159
NEUTROPENIABlood and lymphatic system disorders0/1611/1530/1560/159
CRITICAL ILLNESS POLYNEUROPATHYNervous system disorders0/1611/1530/1560/159
ASTHMATIC CRISISRespiratory, thoracic and mediastinal disorders0/1611/1530/1560/159
BARRETTS OESOPHAGUSGastrointestinal disorders0/1611/1530/1560/159
Most frequent other events
Showing 10 of 26
Most frequent other events
EventAZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlacebo
NASOPHARYNGITISInfections and infestations18/16113/15318/15631/159
HEADACHENervous system disorders12/16112/1536/15615/159
BRONCHITISInfections and infestations7/1616/1531/15610/159
OtherGastrointestinal disorders8/1614/1531/1567/159
OtherRespiratory, thoracic and mediastinal disorders5/1615/1531/1567/159
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations3/1612/1536/1563/159
BACK PAINMusculoskeletal and connective tissue disorders2/1614/1531/1566/159
VIRAL UPPER RESPIRATORY TRACT INFECTIONInfections and infestations6/1613/1533/1562/159
PHARYNGITISInfections and infestations3/1614/1535/1565/159
OtherMusculoskeletal and connective tissue disorders5/1612/1535/1565/159

Baseline characteristics

Age, Continuous
Age, Continuous(years)AZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlaceboTotal
Mean51 ± 11.652 ± 12.753 ± 11.554 ± 11.152 ± 11.8
Sex: Female, Male
Sex: Female, Male(Participants)AZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlaceboTotal
Female107113104120444
Male55435642196
FEV1 pre-bronchodilator
FEV1 pre-bronchodilator(percentage of predicted normal)AZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlaceboTotal
Median63.74 (30.11 to 85.41)66.35 (29.92 to 113.57)65.76 (32.57 to 123.86)61.58 (31.13 to 84.86)64.93 (29.92 to 123.86)
FEV1 post-bronchodilator
FEV1 post-bronchodilator(percentage of predicted normal)AZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlaceboTotal
Median74.34 (32.33 to 105.44)77.95 (30.38 to 112.83)76.31 (34.88 to 112.89)72.19 (31.26 to 111.88)75.22 (30.38 to 112.89)
Reversibility
Reversibility(percentage change)AZD5069 45 mg BIDAZD5069 15 mg BIDAZD5069 5 mg BIDPlaceboTotal
Mean18.73 ± 20.61716.05 ± 15.58018.41 ± 20.57418.45 ± 16.34217.93 ± 18.438
08

Study locations

99 sites
  • Research Site
    Gotse Delchev, Bulgaria
  • Research Site
    Kozloduy, Bulgaria
  • Research Site
    Petrich, Bulgaria
  • Research Site
    Pleven, Bulgaria
  • Research Site
    Razgrad, Bulgaria
  • Research Site
    Ruse, Bulgaria
  • Research Site
    Sofia, Bulgaria
  • Research Site
    Vidin, Bulgaria
  • Research Site
    Mount Pearl, Newfoundland and Labrador, Canada
  • Research Site
    Hamilton, Ontario, Canada
  • Research Site
    Toronto, Ontario, Canada
  • Research Site
    Montreal, Quebec, Canada
  • Research Site
    Saint-Romuald, Quebec, Canada
  • Research Site
    Quebec, Canada
  • Research Site
    Brno, Czech Republic
  • Research Site
    Jindrichuv Hradec, Czech Republic
  • Research Site
    Karlovy Vary, Czech Republic
  • Research Site
    Kutna Hora, Czech Republic
  • Research Site
    Melnik, Czech Republic
  • Research Site
    Praha 5, Czech Republic
  • Research Site
    Praha 6, Czech Republic
  • Research Site
    Strakonice, Czech Republic
  • Research Site
    Tabor, Czech Republic
  • Research Site
    Berlin, Germany
  • Research Site
    Großhansdorf, Germany
  • Research Site
    Hamburg, Germany
  • Research Site
    Hannover, Germany
  • Research Site
    München, Germany
  • Research Site
    Aszód, Hungary
  • Research Site
    Baja, Hungary
  • Research Site
    Balassagyarmat, Hungary
  • Research Site
    Budapest, Hungary
  • Research Site
    Cegléd, Hungary
  • Research Site
    Gyula, Hungary
  • Research Site
    Komárom, Hungary
  • Research Site
    Makó, Hungary
  • Research Site
    Monor, Hungary
  • Research Site
    Nyíregyháza, Hungary
  • Research Site
    Pécs, Hungary
  • Research Site
    Szeged, Hungary
  • Research Site
    Szombathely, Hungary
  • Research Site
    Százhalombatta, Hungary
  • Research Site
    Guadalajara, Mexico
  • Research Site
    Mexico, Mexico
  • Research Site
    Monterrey, Mexico
  • Research Site
    Białystok, Poland
  • Research Site
    Gdańsk, Poland
  • Research Site
    Giżycko, Poland
  • Research Site
    Kraków, Poland
  • Research Site
    Lublin, Poland
  • Research Site
    Poznań, Poland
  • Research Site
    Proszowice, Poland
  • Research Site
    Skierniewice, Poland
  • Research Site
    Tarnów, Poland
  • Research Site
    Wrocław, Poland
  • Research Site
    Łódź, Poland
  • Research Site
    Żnin, Poland
  • Research Site
    Brasov, Romania
  • Research Site
    Bucharest, Romania
  • Research Site
    Constanta, Romania
  • Research Site
    Deva, Romania
  • Research Site
    Iasi, Romania
  • Research Site
    Ekaterinburg, Russian Federation
  • Research Site
    Izhevsk, Russian Federation
  • Research Site
    Kazan, Russian Federation
  • Research Site
    Moscow, Russian Federation
  • Research Site
    Saint Petersburg, Russian Federation
  • Research Site
    Saint-Petersburg, Russian Federation
  • Research Site
    St. Petersburg, Russian Federation
  • Research Site
    Vladikavkaz, Russian Federation
  • Research Site
    Yaroslavl, Russian Federation
  • Research Site
    Bardejov, Slovakia
  • Research Site
    Bratislava, Slovakia
  • Research Site
    Komarno, Slovakia
  • Research Site
    Kosice, Slovakia
  • Research Site
    Levice, Slovakia
  • Research Site
    Poprad, Slovakia
  • Research Site
    Spisska Nova Ves, Slovakia
  • Research Site
    Surany, Slovakia
  • Research Site
    Topolcany, Slovakia
  • Research Site
    Trencin, Slovakia
  • Research Site
    Zvolen, Slovakia
  • Research Site
    Amanzimtoti, South Africa
  • Research Site
    Cape Town, South Africa
  • Research Site
    Durban, South Africa
  • Research Site
    Pretoria, South Africa
  • Research Site
    Umkomaas, South Africa
  • Research Site
    Donetsk, Ukraine
  • Research Site
    Ivano-Frankivsk, Ukraine
  • Research Site
    Kharkiv, Ukraine
  • Research Site
    Kyiv, Ukraine
  • Research Site
    Vinnytsia, Ukraine
  • Research Site
    Zaporizhzhya, Ukraine
  • Research Site
    Zaporizhzhzya, Ukraine
  • Research Site
    Zaporozye, Ukraine
  • Research Site
    Birmingham, United Kingdom
  • Research Site
    Dundee, United Kingdom
  • Research Site
    Liverpool, United Kingdom
  • Research Site
    London, United Kingdom
09

References and documents

Publications

  • O'Byrne PM, Metev H, Puu M, Richter K, Keen C, Uddin M, Larsson B, Cullberg M, Nair P. Efficacy and safety of a CXCR2 antagonist, AZD5069, in patients with uncontrolled persistent asthma: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2016 Oct;4(10):797-806. doi: 10.1016/S2213-2600(16)30227-2. Epub 2016 Aug 27. PubMed 27574788 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01704495
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Oct 11, 2012
Start date
Nov 2012
Primary completion
Aug 2014
Completion
Aug 2014
Results posted
Mar 1, 2016
Last update
Mar 1, 2016

Study contacts

Bengt Larsson, MEDICAL SCIENCE DIRECTOR
study director · AZ Mondal R&D, Sweden
View the source record on ClinicalTrials.gov ↗

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