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CompletedNCT02178059Updated Mar 1, 2017Results posted

Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2

A Phase 1 interventional study of terbutaline sulphate delivered dose and terbutaline sulphate metered dose in Healthy Volunteers, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-01.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via current version of Turbuhaler with inhalation via a new version

Read the detailed description

An Open-label, Single-dose, 2-period Cross over Study in Healthy Male and Female Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg after Inhalation via the M3 Turbuhaler (New Version) Compared with the M2 Turbuhaler (Current Version)

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Healthy volunteers, pharmacokinetic, inhalation
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 34 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration 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 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Female and male volunteers aged between 18 and 65 years, both inclusive
  2. Healthy as judged by the Principal Investigator after medical history, physical examination, 12-lead ECG, laboratory tests (including HIV, HBsAg and hepatitis C antibody tests) and assessments of pulse rate and blood pressure
  3. Ability to use a Turbuhaler according to the provided instructions, as judged by the Principal Investigator or the study nurse
  4. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg -

Exclusion criteria

Exclusion Criteria:

  1. History or presence of respiratory, gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs (except for cholecystectomy)
  2. Current smokers or those who have smoked or used nicotine products within the previous 3 months should be excluded
  3. Plasma donation within 1 month of screening or any blood donation or blood loss of more than 500 mL during the 3 months prior to screening
  4. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Principal Investigator or history of hypersensitivity to terbutaline (or drugs of a similar chemical structure or class) or inhaled lactose
  5. Positive screen for drugs of abuse and/or alcohol and/or cotinine at screening (Visit 1) or on admission to the study centre (Day -1) prior to administration of the investigational medical product (IMP) on Day 1 -
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Bricanyl Turbuhaler M3

    0.4 mg terbutaline sulphate (delivered dose) per inhalation

    Drug: terbutaline sulphate delivered dose

  • Active comparator
    Bricanyl Turbuhaler M2

    0.5 mg terbutaline sulphate (metered dose) per inhalation

    Drug: terbutaline sulphate metered dose

Interventions

  • Drugterbutaline sulphate delivered dose

    0.4 mg terbutaline sulphate (delivered dose) per inhalation

    Also known as: Turbuhaler New Version

  • Drugterbutaline sulphate metered dose

    0.5 mg terbutaline sulphate (metered dose) per inhalation

    Also known as: Turbuhaler Current Version

06

What researchers measure

Primary outcomes

  1. Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]

    These will be taken at each treatment period

    Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose

  2. Maximum Observed Plasma Concentration (Cmax)

    These will be taken at each treatment period

    Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose

Secondary outcomes

  1. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    These will be taken at each treatment period

    Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose

  2. Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)

    These will be taken at each treatment period

    Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose

  3. Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]

    These will be taken at each treatment period

    Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose

  4. Terminal Half-life (t1/2)

    These will be taken at each treatment period

    Time frame: Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose

07

Results

Posted Aug 2, 2016

Participant flow

This was a single centre study conducted in the UK.

First Intervention
Participant flow — First Intervention
MilestoneM3 First, Then M2M2 First, Then M3
Started1717
Completed1717
Not completed00
Washout
Participant flow — Washout
MilestoneM3 First, Then M2M2 First, Then M3
Started1717
Completed1617
Not completed10
Withdrew: Physician decision10
Second Intervention
Participant flow — Second Intervention
MilestoneM3 First, Then M2M2 First, Then M3
Started1617
Completed1617
Not completed00

Outcome measures

PrimaryArea Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]

These will be taken at each treatment period

Time frame:
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Reported as:
Geometric mean · nmol*h/L
Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]
nmol*h/LBricanyl Turbuhaler M3Bricanyl Turbuhaler M2
Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]89.04 (80.84 to 98.07)100.9 (91.54 to 111.3)
Statistical analysis
  • Bricanyl Turbuhaler M3 vs Bricanyl Turbuhaler M2 · Ratio of geometric means (%): 88.20 · 90% CI 81.03 to 96.02Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)
SecondaryTime to Reach Maximum Observed Plasma Concentration (Tmax)

These will be taken at each treatment period

Time frame:
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Reported as:
Median · hour
Time to Reach Maximum Observed Plasma Concentration (Tmax)
hourBricanyl Turbuhaler M3Bricanyl Turbuhaler M2
Time to Reach Maximum Observed Plasma Concentration (Tmax)1.33 (1.33 to 1.67)1.33 (1.33 to 1.67)
Statistical analysis
  • Bricanyl Turbuhaler M3 vs Bricanyl Turbuhaler M2 · Wilcoxon signed rank test · p = 0.8052 · Median difference (final values): 0.00 · 90% CI -0.17 to 0.17
SecondaryArea Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)

These will be taken at each treatment period

Time frame:
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Reported as:
Geometric mean · nmol*h/L
Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)
nmol*h/LBricanyl Turbuhaler M3Bricanyl Turbuhaler M2
Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)96.63 (87.68 to 106.5)109.7 (99.43 to 121.0)
SecondaryArea Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]

These will be taken at each treatment period

Time frame:
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Reported as:
Geometric mean · nmol*h/L
Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]
nmol*h/LBricanyl Turbuhaler M3Bricanyl Turbuhaler M2
Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]89.0 ± 29.5101 ± 27.8
SecondaryTerminal Half-life (t1/2)

These will be taken at each treatment period

Time frame:
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Reported as:
Geometric mean · hour
Terminal Half-life (t1/2)
hourBricanyl Turbuhaler M3Bricanyl Turbuhaler M2
Terminal Half-life (t1/2)11.7 ± 8.911.8 ± 10.9
PrimaryMaximum Observed Plasma Concentration (Cmax)

These will be taken at each treatment period

Time frame:
Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
Reported as:
Geometric mean · nmol/L
Maximum Observed Plasma Concentration (Cmax)
nmol/LBricanyl Turbuhaler M3Bricanyl Turbuhaler M2
Maximum Observed Plasma Concentration (Cmax)12.00 (10.73 to 13.40)13.12 (11.73 to 14.67)
Statistical analysis
  • Bricanyl Turbuhaler M3 vs Bricanyl Turbuhaler M2 · Ratio of geometric means (%): 91.44 · 90% CI 84.82 to 98.58Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bricanyl Turbuhaler M3—0/34 (0%)12/34 (35.3%)
Bricanyl Turbuhaler M2—0/33 (0%)11/33 (33.3%)
Most frequent other events
Most frequent other events
EventBricanyl Turbuhaler M3Bricanyl Turbuhaler M2
HeadacheNervous system disorders9/347/33
DizzinessNervous system disorders2/344/33
Back PainMusculoskeletal and connective tissue disorders2/340/33

Baseline characteristics

All subjects

Age, Continuous
Age, Continuous(years)Randomized Subjects
Mean42 ± 11
Gender
Gender(Participants)Randomized Subjects
Female18
Male16
08

Study locations

1 site
  • Research Site
    London, United Kingdom
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02178059
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jun 30, 2014
Start date
Aug 2014
Primary completion
Nov 2014
Completion
Nov 2014
Results posted
Aug 2, 2016
Last update
Mar 1, 2017

Study contacts

Amitava Ganguli, MB ChB, MRCP
principal investigator · Quintiles London United Kingdom
Göran Eckervall, MD
study director · Astrazeneca Mölndal, Sweden
Ola Beckman, MD
study chair · Astrazeneca Mölndal, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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