Exercise Induced AsthmaPhase 3NCT00127166
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
A Phase 3 study testing Montelukast sodium, Salmeterol xinafoate and Fluticasone propionate in people with Exercise Induced Asthma, run by Organon and Co.
Trial summary
The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Exercise Induced Asthma
- What is being tested?
- Montelukast sodium, Salmeterol xinafoate and Fluticasone propionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Nov 2008
- Phase
- Phase 3
- 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-14 year old children with a history of asthma for at least 12 months
- must demonstrate airway constriction brought on by exercise
Who cannot join
- is taking any medications that are not allowed in the study
About this study
Official title: A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years
The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.
- Conditions
- Exercise Induced Asthma
- Being tested
- Montelukast sodium, Salmeterol xinafoate, Fluticasone propionate, Montelukast matching placebo, Salmeterol matching placebo
- 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.
Montelukast sodiumDrug
Montelukast 5 mg chewable tablet once daily
Salmeterol xinafoateDrug
Salmeterol 50 mcg dry powder per actuation inhaled twice daily
Fluticasone propionateDrug
Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
Montelukast matching placeboDrug
Matching placebo to montelukast oral tablet administered once daily.
Salmeterol matching placeboDrug
Matching placebo to salmeterol dry powder for inhalation administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| Montelukast/Salmeterol | Experimental | Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. Receives: Drug: Montelukast sodium; Drug: Salmeterol xinafoate; Drug: Fluticasone propionate; Drug: Montelukast matching placebo; Drug: Salmeterol matching placebo |
| Salmeterol/Montelukast | Experimental | Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. Receives: Drug: Montelukast sodium; Drug: Salmeterol xinafoate; Drug: Fluticasone propionate; Drug: Montelukast matching placebo; Drug: Salmeterol matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Post-exercise Percent (%) Fall in FEV1
The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.
Measured: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Secondary outcomes (4)
Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.
Measured: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Maximum FEV1 % Predicted Following First Beta-agonist Use
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.
Measured: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Time to Recovery to Within 5% of Baseline FEV1
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.
Measured: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.
Measured: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startDec 2005
- Primary completionNov 2008
- Study completionNov 2008
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127166
- Sponsor's protocol ID
- 0476-911
- Other IDs
- 2004_006
- Status last verified
- Feb 2022
- First submitted
- 30 Jun 2005
- Last updated
- 10 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fogel RB, Rosario N, Aristizabal G, Loeys T, Noonan G, Gaile S, Smugar SS, Polos PG. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol. 2010 Jun;104(6):511-7. doi: 10.1016/j.anai.2009.12.011.
PubMed 20568384
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years
- ClinicalTrials.gov ID
- NCT00127166
- Acronym / sponsor ID
- 0476-911
- Conditions
- Exercise Induced Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 5 Aug 2005 (estimated)
- Results
- Posted 3 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast/Salmeterol | Experimental | Drug: Montelukast sodium, Drug: Salmeterol xinafoate, Drug: Fluticasone propionate, Drug: Montelukast matching placebo, Drug: Salmeterol matching placeboPeriod I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. |
| Salmeterol/Montelukast | Experimental | Drug: Montelukast sodium, Drug: Salmeterol xinafoate, Drug: Fluticasone propionate, Drug: Montelukast matching placebo, Drug: Salmeterol matching placeboPeriod I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6-14 year old children with a history of asthma for at least 12 months
- must demonstrate airway constriction brought on by exercise
Key exclusion criteria (1 listed)
- is taking any medications that are not allowed in the study
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 |
|---|---|---|
| Montelukast sodiumMontelukast 5 mg chewable tablet once daily | Drug | Montelukast/Salmeterol, Salmeterol/Montelukast |
| Salmeterol xinafoateSalmeterol 50 mcg dry powder per actuation inhaled twice daily | Drug | Montelukast/Salmeterol, Salmeterol/Montelukast |
| Fluticasone propionateFluticasone (50 mcg per actuation) 100 mcg inhaled twice daily | Drug | Montelukast/Salmeterol, Salmeterol/Montelukast |
| Montelukast matching placeboMatching placebo to montelukast oral tablet administered once daily. | Drug | Montelukast/Salmeterol, Salmeterol/Montelukast |
| Salmeterol matching placeboMatching placebo to salmeterol dry powder for inhalation administered twice daily | Drug | Montelukast/Salmeterol, Salmeterol/Montelukast |
Primary outcome
Maximum Post-exercise Percent (%) Fall in FEV1
Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.
4 secondary outcomes
Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))
Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Maximum FEV1 % Predicted Following First Beta-agonist Use
Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Time to Recovery to Within 5% of Baseline FEV1
Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use
Time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20568384Fogel RB, Rosario N, Aristizabal G, Loeys T, Noonan G, Gaile S, Smugar SS, Polos PG. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol. 2010 Jun;104(6):511-7. doi: 10.1016/j.anai.2009.12.011.
- Individual participant dataSharing planned: No
Related trials for Exercise Induced Asthma
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COPD (Chronic Obstructive Pulmonary Disease), Asthma (Diagnosis)
RecruitingObservational study
Swiss Paediatric Airway Cohort
Asthma, Wheezing
Recruiting
The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception
Asthma in Children, Exercise Induced Asthma
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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Montelukast sodium, Salmeterol xinafoate and Fluticasone propionate in people with Exercise Induced Asthma, run by Organon and Co.
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 1 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 3 Dec 2009). 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?
Maximum Post-exercise Percent (%) Fall in FEV1 (time frame: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)). 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 NCT00127166, 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 10 May 2024.