Exercise Induced AsthmaPhase 2MIANCT00989833
Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients
A Phase 2 study testing budesonide, terbutaline and budesonide/formoterol in people with Exercise Induced Asthma, run by AstraZeneca at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Exercise Induced Asthma
- What is being tested?
- budesonide, terbutaline and budesonide/formoterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Sep 2009to Jul 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of exercise induced asthma
- Maximum 4 asthmatic episodes per week requiring use of reliever medication
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Sweden8 sites
Research Site
Gothenburg
Research Site
Huddinge
Research Site
Linköping
Research Site
Luleå
Research Site
Lund
Research Site
Skene
Research Site
Stockholm
Research Site
Uppsala
About this study
Official title: A Randomised, Double Blind, Placebo Controlled, Parallel-group Study With Use of Budesonide/Formoterol "As-needed", or Terbutaline "As-needed" or Regular Use of Budesonide + Terbutaline "As-needed", in Patients With Mild Intermittent Asthma
- 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
Read more
- 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
- Conditions
- Exercise Induced Asthma
- Being tested
- budesonide, terbutaline, budesonide/formoterol
- Keywords
- Exercise induced asthma, Mild intermittent asthma, Exercise induced bronchoconstriction
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
Also called Pulmicort Turbuhaler
400 yg x 1
terbutalineDrug
Also called Bricanyl Turbuhaler
0.4 mg as-needed
budesonide/formoterolDrug
Also called Symbicort Turbuhaler
160/4.5 yg as-needed
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | budesonide 400yg + terbutaline 0.4 mg as-needed Receives: Drug: budesonide; Drug: terbutaline |
| B | Active comparator | placebo + terbutaline 0.4 mg as-needed Receives: Drug: terbutaline |
| C | Active comparator | placebo + budesonide/formoterol 160/4.5 yg as-needed Receives: Drug: budesonide/formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks
FEV1
Measured: Baseline and Visit 6
Secondary outcomes (7)
Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks
FEV1
Measured: Baseline and 3 weeks
Bronchial Responsiveness to Mannitol
Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)
Measured: Baseline and 6 weeks
Concentration of Exhaled Nitric Oxide
Measured: 6 weeks
Use of as Needed Medication
Mean number of as needed inhalations taken before exercise
Measured: 6 weeks
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.
Measured: Baseline e and 6 weeks
Diary Recording of Asthma Symptoms
Asthma symptoms during days with exercise
Measured: 6 weeks
Number of Participants With an Adverse Event During the Study
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise Induced AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kjell Larsson, Professor, Principal investigator, AstraZeneca MC SwedenGeorgios Stratelis, Study director, AstraZeneca MC Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989833
- Sponsor's protocol ID
- D5890L00032
- Acronym
- MIA
- Status last verified
- Jul 2012
- First submitted
- 30 Sep 2009
- Last updated
- 14 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo Controlled, Parallel-group Study With Use of Budesonide/Formoterol "As-needed", or Terbutaline "As-needed" or Regular Use of Budesonide + Terbutaline "As-needed", in Patients With Mild Intermittent Asthma
- ClinicalTrials.gov ID
- NCT00989833
- Acronym / sponsor ID
- MIA / D5890L00032
- Conditions
- Exercise Induced Asthma
- Keywords
- Exercise induced asthma, Mild intermittent asthma, Exercise induced bronchoconstriction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Posted 14 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: budesonide, Drug: terbutalinebudesonide 400yg + terbutaline 0.4 mg as-needed |
| B | Active comparator | Drug: terbutalineplacebo + terbutaline 0.4 mg as-needed |
| C | Active comparator | Drug: budesonide/formoterolplacebo + budesonide/formoterol 160/4.5 yg as-needed |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- History of exercise induced asthma
- Maximum 4 asthmatic episodes per week requiring use of reliever medication
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonideAlso: Pulmicort Turbuhaler400 yg x 1 | Drug | A |
| terbutalineAlso: Bricanyl Turbuhaler0.4 mg as-needed | Drug | A, B |
| budesonide/formoterolAlso: Symbicort Turbuhaler160/4.5 yg as-needed | Drug | C |
Primary outcome
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks
Time frame: Baseline and Visit 6
FEV1
7 secondary outcomes
Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks
Time frame: Baseline and 3 weeks
Bronchial Responsiveness to Mannitol
Time frame: Baseline and 6 weeks
Concentration of Exhaled Nitric Oxide
Time frame: 6 weeks
Use of as Needed Medication
Time frame: 6 weeks
Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)
Time frame: Baseline e and 6 weeks
Diary Recording of Asthma Symptoms
Time frame: 6 weeks
Number of Participants With an Adverse Event During the Study
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24092567Lazarinis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjell Larsson, Professor principal investigator
AstraZeneca MC Sweden
Georgios Stratelis study director
AstraZeneca MC Sweden
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing budesonide, terbutaline and budesonide/formoterol in people with Exercise Induced Asthma, run by AstraZeneca at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks (time frame: Baseline and Visit 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00989833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2012.