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CompletedNCT00989833MIAUpdated Aug 14, 2012Results posted

Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

A Phase 2 interventional study of budesonide and terbutaline in Exercise Induced Asthma, sponsored by AstraZeneca. Completed at 10 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2012-08-14.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

  1. The primary objective of this study is:

    • To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma

  2. The secondary objectives of this study are:

    • To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
    • To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event
02

Conditions studied

  • Exercise Induced Asthma

Keywords

  • Exercise induced asthma
  • Mild intermittent asthma
  • Exercise induced bronchoconstriction
03

In context

Asthma, Exercise-Induced

50 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.

This study's enrollment of 66 is above the median of 47 across 37 interventional studies indexed under Asthma, Exercise-Induced.

Browse Asthma, Exercise-Induced studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

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

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • History of exercise induced asthma
  • Maximum 4 asthmatic episodes per week requiring use of reliever medication

Exclusion criteria

Exclusion Criteria:

  • No previous treatment with inhaled oral corticosteroids during the last month before randomisation
  • Suspected poor capability to follow instructions, ie to exercise 3-4 times a week
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
66 participants (actual)

Study arms

  • Active comparator
    A

    budesonide 400yg + terbutaline 0.4 mg as-needed

    Drug: budesonide · Drug: terbutaline

  • Active comparator
    B

    placebo + terbutaline 0.4 mg as-needed

    Drug: terbutaline

  • Active comparator
    C

    placebo + budesonide/formoterol 160/4.5 yg as-needed

    Drug: budesonide/formoterol

Interventions

  • Drugbudesonide

    400 yg x 1

    Also known as: Pulmicort Turbuhaler

  • Drugterbutaline

    0.4 mg as-needed

    Also known as: Bricanyl Turbuhaler

  • Drugbudesonide/formoterol

    Drug pages: Budesonide · Formoterol

    160/4.5 yg as-needed

    Also known as: Symbicort Turbuhaler

06

What researchers measure

Primary outcomes

  1. Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks

    FEV1

    Time frame: Baseline and Visit 6

Secondary outcomes

  1. Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks

    FEV1

    Time frame: Baseline and 3 weeks

  2. Bronchial Responsiveness to Mannitol

    Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)

    Time frame: Baseline and 6 weeks

  3. Concentration of Exhaled Nitric Oxide

    Time frame: 6 weeks

  4. Use of as Needed Medication

    Mean number of as needed inhalations taken before exercise

    Time frame: 6 weeks

  5. Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)

    Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk.

    Time frame: Baseline e and 6 weeks

  6. Diary Recording of Asthma Symptoms

    Asthma symptoms during days with exercise

    Time frame: 6 weeks

  7. Number of Participants With an Adverse Event During the Study

    Time frame: 6 weeks

07

Results

Posted Aug 14, 2012

Participant flow

On Visit 1, a total of 189 patients, aged 12-67, were enrolled at 10 study sites in 2 countries: Sweden and Norway. Of 189 enrolled patients, 66 patients were randomized and allocated to study treatment on Visit 3 (7 patients in Norway and 59 patients in Sweden).

Participant flow — Overall Study
MilestoneBudesonide/TerbutalineTerbutalineBudesonide/Formoterol
Started212223
Completed191921
Not completed232
Withdrew: Lost to follow-up010
Withdrew: Protocol violation121
Withdrew: Withdrawal by subject001
Withdrew: Incorrectly randomized100

Outcome measures

PrimaryPercent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks

FEV1

Time frame:
Baseline and Visit 6
Reported as:
Mean · Percent change
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks
Percent changeBudesonide/TerbutalineTerbutalineBudesonide/Formoterol
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks-5.85 ± 6.500.61 ± 10.92-5.24 ± 9.64
SecondaryPercent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks

FEV1

Time frame:
Baseline and 3 weeks
Reported as:
Mean · Percent change
Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks
Percent changeBudesonide/TerbutalineTerbutalineBudesonide/Formoterol
Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks-4.07 ± 5.56-1.19 ± 8.03-3.81 ± 8.68
SecondaryBronchial Responsiveness to Mannitol

Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)

Time frame:
Baseline and 6 weeks
Reported as:
Mean · mg
Bronchial Responsiveness to Mannitol
mgBudesonide/TerbutalineTerbutalineBudesonide/Formoterol
Bronchial Responsiveness to Mannitol67.26 ± 141.98-6.15 ± 95.10151.87 ± 141.09
SecondaryConcentration of Exhaled Nitric Oxide
Time frame:
6 weeks
Reported as:
Mean · ppb
Concentration of Exhaled Nitric Oxide
ppbBudesonide/TerbutalineTerbutalineBudesonide/Formoterol
Concentration of Exhaled Nitric Oxide25.9 ± 20.135.5 ± 36.624.4 ± 22.4
SecondaryUse of as Needed Medication

Mean number of as needed inhalations taken before exercise

Time frame:
6 weeks
Reported as:
Mean · number of inhalations per day
Use of as Needed Medication
number of inhalations per dayBudesonide/TerbutalineTerbutalineBudesonide/Formoterol
Use of as Needed Medication0.6 ± 0.20.8 ± 0.50.7 ± 0.5
SecondaryAsthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)

Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk.

Time frame:
Baseline e and 6 weeks
Reported as:
Mean · units on a scale
Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)
units on a scaleBudesonide/TerbutalineTerbutalineBudesonide/Formoterol
Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)-0.3 ± 0.7-0.2 ± 0.8-0.4 ± 0.7
SecondaryDiary Recording of Asthma Symptoms

Asthma symptoms during days with exercise

Time frame:
6 weeks
Reported as:
Mean · Percent of exercise days
Diary Recording of Asthma Symptoms
Percent of exercise daysBudesonide/TerbutalineTerbutalineBudesonide/Formoterol
Diary Recording of Asthma Symptoms51.1 ± 30.550.9 ± 36.649.8 ± 26.1
SecondaryNumber of Participants With an Adverse Event During the Study
Time frame:
6 weeks
Reported as:
Number · Participants
Number of Participants With an Adverse Event During the Study
ParticipantsBudesonide/TerbutalineTerbutalineBudesonide/Formoterol
Number of Participants With an Adverse Event During the Study131313

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Budesonide/Terbutaline—0/21 (0%)7/21 (33.3%)
Terbutaline—0/22 (0%)10/22 (45.5%)
Budesonide/Formoterol—0/23 (0%)9/23 (39.1%)
Most frequent other events
Most frequent other events
EventBudesonide/TerbutalineTerbutalineBudesonide/Formoterol
Common coldInfections and infestations5/217/225/23
Sore throatRespiratory, thoracic and mediastinal disorders0/210/224/23
CoughRespiratory, thoracic and mediastinal disorders0/213/221/23
GastroenteritisGastrointestinal disorders1/210/223/23
HeadacheGeneral disorders1/212/220/23
Slight FeverGeneral disorders0/212/220/23
FallInjury, poisoning and procedural complications0/210/222/23

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Budesonide/TerbutalineTerbutalineBudesonide/FormoterolTotal
<=18 years25512
Between 18 and 65 years18161852
>=65 years1102
Sex: Female, Male
Sex: Female, Male(Participants)Budesonide/TerbutalineTerbutalineBudesonide/FormoterolTotal
Female1061430
Male1116936
08

Study locations

10 sites
  • Research Site
    Oslo, Norway
  • Research Site
    Trondheim, Norway
  • Research Site
    Gothenburg, Sweden
  • Research Site
    Huddinge, Sweden
  • Research Site
    Linköping, Sweden
  • Research Site
    Luleå, Sweden
  • Research Site
    Lund, Sweden
  • Research Site
    Skene, Sweden
  • Research Site
    Stockholm, Sweden
  • Research Site
    Uppsala, Sweden
09

References and documents

Publications

  • Lazarinis N, Jorgensen L, Ekstrom T, Bjermer L, Dahlen B, Pullerits T, Hedlin G, Carlsen KH, Larsson K. Combination of budesonide/formoterol on demand improves asthma control by reducing exercise-induced bronchoconstriction. Thorax. 2014 Feb;69(2):130-6. doi: 10.1136/thoraxjnl-2013-203557. Epub 2013 Oct 3. PubMed 24092567 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Jul 2010 and a completion of Jul 2010. It does not say whether these dates are actual or estimated.

Results were first posted in Aug 2012, 2 years 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2009
First posted
Oct 6, 2009
Start
Sep 2009
Primary completionActual
Jul 2010
CompletionActual
Jul 2010
Results first posted
Aug 14, 2012
Last update
Aug 14, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00989833
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Oct 6, 2009
Start date
Sep 2009
Primary completion
Jul 2010
Completion
Jul 2010
Results posted
Aug 14, 2012
Last update
Aug 14, 2012

Study contacts

Kjell Larsson, Professor
principal investigator · AstraZeneca MC Sweden
Georgios Stratelis
study director · AstraZeneca MC Sweden

Oversight

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

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