Exercise-induced Bronchoconstriction (EIB)Phase 4NCT00534976
The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)
A Phase 4 study testing Comparator: montelukast sodium in people with Exercise-induced Bronchoconstriction (EIB), run by Organon and Co.
Trial summary
This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Exercise-induced Bronchoconstriction (EIB)
- What is being tested?
- Comparator: montelukast sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Mar 2010
- Phase
- Phase 4
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child is 4 years to 14 years of age
- The child is a non smoker
- The child has exercise-induced bronchoconstriction (EIB)
Who cannot join
- The child has active or chronic breathing disease, other than asthma
- The child has required insertion of a breathing tube for asthma
- The child had major surgery within the last 4 weeks
- The child is currently in the hospital
- The child has or had an upper respiratory tract infection within the last 2 weeks
- The child has been hospitalized or visited the emergency room or had a change in their medication for asthma within the last 4 weeks
Show all 9Show fewer
- The child has been in a research study in the last 4 weeks
- The child has stomach, brain, heart, kidney or liver disease
- The child drinks more that 4 caffeinated drinks a day
About this study
Official title: A Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Evaluate the Effects of a Single Oral Dose of Montelukast, Compared With Placebo, on Exercise-Induced Bronchoconstriction (EIB) in Pediatric Patients Aged 4 to 14 Years
This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.
- Being tested
- Comparator: montelukast sodium, Comparator: Comparator: placebo (unspecified)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: montelukast sodiumDrug
Patients 4-5 years: 4 mg Montelukast chewable tablet daily
Patients 6-14 years: 5 mg chewable tablet daily
Comparator: Comparator: placebo (unspecified)Drug
Patients 4-5 years: 4 mg Pbo chewable tablet daily
Patients 6-14 years: 5 mg Pbo chewable tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Montelukast Sodium | Experimental | Participants 4-5 years: A single dose of 4 mg Montelukast chewable tablet daily, crossing over to matching placebo (Pbo) after a 3- to 7-day washout period (no participants 4-5 years were enrolled)
Participants 6-14 years: A single dose of 5 mg Montelukast chewable tablet daily, crossing over to matching Pbo after a 3- to 7-day washout period Receives: Drug: Comparator: montelukast sodium |
| Placebo | Experimental | Participants 4-5 years: A single dose of 4 mg Pbo chewable tablet daily, crossing over to Montelukast 4 mg chewable tablet after a 3- to 7-day washout period (no participants 4-5 years of age were enrolled)
Participants 6-14 years: A single dose of 5 mg Pbo chewable tablet daily, crossing over to Montelukast 5 mg chewable tablet after a 3- to 7-day washout period Receives: Drug: Comparator: Comparator: placebo (unspecified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose
Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, \& 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise \& Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.
Measured: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose
Secondary outcomes (7)
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose
Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, \& 60 mins after each exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. The calculation used to produce the resulted results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise \& Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.
Measured: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose
Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose
AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.
Measured: Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose
Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose
AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy.
Measured: Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose
Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose
This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred \& the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time.
Spirometry measurements were taken 5 mins prior to each exercise challenge \& immediately, 5, 10, 15, 30, 45, \& 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 \& 90 mins.
The 2-hour exercise challenges occurred 2 hours after the witnessed dose of medication.
Measured: 0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose
Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose
This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred \& the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge \& immediately, 5, 10, 15, 30, 45 \& 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 \& 90 mins. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of medication.
Measured: 0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose
Number of Participants Requiring Rescue Medication at 2 Hours Postdose
This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication.
Measured: 0-90 minutes after the exercise challenge at 2 hours postdose
Number of Participants Requiring Rescue Medication at 24 Hours Postdose
This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication.
Measured: 0-90 minutes after the exercise challenge at 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startFeb 2008
- Primary completionMar 2010
- Study completionMar 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 Bronchoconstriction (EIB)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 364 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
- NCT00534976
- Sponsor's protocol ID
- 0476-377
- Other IDs
- 2007_586
- Status last verified
- Jan 2022
- First submitted
- 21 Sep 2007
- Last updated
- 13 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Wasfi YS, Kemp JP, Villaran C, Massaad R, Xin W, Smugar SS, Knorr BA, Philip G. Onset and duration of attenuation of exercise-induced bronchoconstriction in children by single-dose of montelukast. Allergy Asthma Proc. 2011 Nov-Dec;32(6):453-9. doi: 10.2500/aap.2011.32.3482.
PubMed 22221440
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Evaluate the Effects of a Single Oral Dose of Montelukast, Compared With Placebo, on Exercise-Induced Bronchoconstriction (EIB) in Pediatric Patients Aged 4 to 14 Years
- ClinicalTrials.gov ID
- NCT00534976
- Acronym / sponsor ID
- 0476-377
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 7 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast Sodium | Experimental | Drug: Comparator: montelukast sodiumParticipants 4-5 years: A single dose of 4 mg Montelukast chewable tablet daily, crossing over to matching placebo (Pbo) after a 3- to 7-day washout period (no participants 4-5 years were enrolled) Participants 6-14 years: A single dose of 5 mg Montelukast chewable tablet daily, crossing over to matching Pbo after a 3- to 7-day washout period |
| Placebo | Experimental | Drug: Comparator: Comparator: placebo (unspecified)Participants 4-5 years: A single dose of 4 mg Pbo chewable tablet daily, crossing over to Montelukast 4 mg chewable tablet after a 3- to 7-day washout period (no participants 4-5 years of age were enrolled) Participants 6-14 years: A single dose of 5 mg Pbo chewable tablet daily, crossing over to Montelukast 5 mg chewable tablet after a 3- to 7-day washout period |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The child is 4 years to 14 years of age
- The child is a non smoker
- The child has exercise-induced bronchoconstriction (EIB)
Key exclusion criteria (9 listed)
- The child has active or chronic breathing disease, other than asthma
- The child has required insertion of a breathing tube for asthma
- The child had major surgery within the last 4 weeks
- The child is currently in the hospital
- The child has or had an upper respiratory tract infection within the last 2 weeks
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 |
|---|---|---|
| Comparator: montelukast sodiumPatients 4-5 years: 4 mg Montelukast chewable tablet daily Patients 6-14 years: 5 mg chewable tablet daily | Drug | Montelukast Sodium |
| Comparator: Comparator: placebo (unspecified)Patients 4-5 years: 4 mg Pbo chewable tablet daily Patients 6-14 years: 5 mg Pbo chewable tablet daily | Drug | Placebo |
Primary outcome
Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose
Time frame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose
Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, \& 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise \& Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy.
7 secondary outcomes
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose
Time frame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose
Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose
Time frame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose
Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose
Time frame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose
Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose
Time frame: 0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose
Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose
Time frame: 0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose
Number of Participants Requiring Rescue Medication at 2 Hours Postdose
Time frame: 0-90 minutes after the exercise challenge at 2 hours postdose
Number of Participants Requiring Rescue Medication at 24 Hours Postdose
Time frame: 0-90 minutes after the exercise challenge at 24 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22221440Wasfi YS, Kemp JP, Villaran C, Massaad R, Xin W, Smugar SS, Knorr BA, Philip G. Onset and duration of attenuation of exercise-induced bronchoconstriction in children by single-dose of montelukast. Allergy Asthma Proc. 2011 Nov-Dec;32(6):453-9. doi: 10.2500/aap.2011.32.3482.
- Individual participant dataSharing planned: No
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 4 study testing Comparator: montelukast sodium in people with Exercise-induced Bronchoconstriction (EIB), 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 3 inclusion and 9 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 13 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 7 Apr 2011). 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 Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose (time frame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose). 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 NCT00534976, 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 13 May 2024.