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CompletedNCT00664937Updated May 9, 2024

Exercise Induced Bronchoconstriction (0476-359)

A Phase 1 interventional study of montelukast sodium and Comparator: placebo (unspecified) in Asthma, Exercise-induced, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by Organon and Co · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

Exercise-induced bronchoconstriction (EIB) is a condition where airways tighten when you exercise and may cause coughing, wheezing, or shortness of breath. In many patients, this condition can cause lung function to drop making it harder to breath. An instrument called a spirometer is commonly used to measure lung function. This traditional means of assessing lung function in asthma is limited in its ability to provide information as to where in the lung the tightness is. Hyperpolarized helium magnetic resonance imaging (3He MRI) is a novel way to see the where air is going in the lungs using an MRI and special gas. The ability to see where the air can and cannot reach in the lungs may help show more accurately if a medication is working to make the asthma better. The purpose of this study is to examine patients with EIB in order to see if 3He MRI provides a better way to measure lung function. Patients will be given either montelukast sodium, a drug to improve the ability to breath with EIB, or placebo and then put on a treadmill to induce an occurrence of airway constriction. The patient's lung function will be measured more than once using both the spirometer and the 3He MRI.

02

Conditions studied

  • Asthma, Exercise-induced
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 24 is below the median of 47 across 37 interventional studies indexed under Asthma, Exercise-Induced.

Browse Asthma, Exercise-Induced studies →

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 55 Years
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

  • Patient is a man or woman who is between the ages of 18 and 55 years of age at Visit 1
  • Female patients of that are of childbearing potential must show they are not pregnant either by blood test Visit 1 and agree to use appropriate single barrier or hormonal contraception during the course of the study and continuing for at least 14 days following the patient's last study visit
  • The patient has stable asthma without any worsening (e.g., requiring unscheduled visit to a physician, hospital or other healthcare resource, new medications or change in dose or frequency of current medications) within 4 weeks of Visit 1 and Visit 2
  • Patient is a current non-smoker and if has a history of smoking, has not smoked for at least 6 months and has a smoking history of no more than 15 pack-years (i.e., 1 pack per day for 15 years)

Exclusion criteria

Exclusion Criteria:

  • Patient has donated a unit of blood within 4 weeks prior to Visit 1 or anticipates donating blood at any time during this study
  • Patient has participated in a clinical trial involving an investigational or marketed medication within the 4 weeks prior to Visit 1 or anticipates participating in any other clinical trial during this study. Patient is currently a regular user, or a recent past abuser (within the past 5 years), of alcohol or illicit drugs
  • Patient is a female who has given birth in the last 8 weeks of Visit 1 or breast feeding an infant
  • Patient is pregnant, or intends to become pregnant during the time course of the study. Patient is hospitalized or has had a major surgical procedure, major trauma requiring medical attention, or significant illness requiring medical attention within 4 weeks of Visit 1
  • Patient does not agree to limit caffeinated beverages and/or chocolate within 8 hours of study visits. Patient has had a worsening of their asthma within 4 weeks of Visit 1 or Visit 2 (i.e., requiring change in type, dose or frequency of medications and/or an unscheduled visit to a health care provider, including emergency room or hospital). Patient has unresolved signs and/or symptoms of an upper respiratory tract infection within 4 weeks of Visit 1 or Visit 2
  • Patient is unwilling to restrict vigorous exercise (e.g., weight lifting or long distance running) or abstain from performing strenuous activity within 18 hours of any visit
  • Patient has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to: pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures) and/or ear implants
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Placebo comparator
    I

    Three period crossover study, 7 week duration: During periods I-III patients will receive oral medication as a single dose before exercise challenge. For the three periods of this study patients will receive in a randomized sequence one dose of montelukast 10mg and a matching placebo during the other 2 periods.

    Drug: montelukast sodium · Drug: Comparator: placebo (unspecified)

  • Placebo comparator
    II

    Three period crossover study, 7 week duration: During periods I-III patients will receive oral medication as a single dose before exercise challenge. For the three periods of this study patients will receive in a randomized sequence one dose of montelukast 10mg and a matching placebo during the other 2 periods.

    Drug: montelukast sodium · Drug: Comparator: placebo (unspecified)

  • Placebo comparator
    III

    Three period crossover study, 7 week duration: During periods I-III patients will receive oral medication as a single dose before exercise challenge. For the three periods of this study patients will receive in a randomized sequence one dose of montelukast 10mg and a matching placebo during the other 2 periods.

    Drug: montelukast sodium · Drug: Comparator: placebo (unspecified)

Interventions

  • Drugmontelukast sodium

    single oral dose, before exercise challenge, of montelukast 10mg; 7 week duration.

    Also known as: MK0476, Singulair®

  • DrugComparator: placebo (unspecified)

    single oral dose, before exercise challenge, of Pbo; 7 week duration.

06

What researchers measure

Primary outcomes

  1. Ventilation volume by 3He MRI, ventilation volume defects by 3He MRI, pulmonary lung function by spirometer

    Time frame: 5 minutes to 1 hour after exercise challenege

Secondary outcomes

  1. Reproducability of ventilation volume and ventilation volume defects as measured by 3He MRI

    Time frame: 3-7 days apart.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00664937
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Apr 23, 2008
Start date
May 2007
Primary completion
Oct 2008
Completion
Oct 2008
Last update
May 9, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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