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
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.
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 →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.
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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)
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)
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)
single oral dose, before exercise challenge, of montelukast 10mg; 7 week duration.
Also known as: MK0476, Singulair®
single oral dose, before exercise challenge, of Pbo; 7 week duration.
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
Reproducability of ventilation volume and ventilation volume defects as measured by 3He MRI
Time frame: 3-7 days apart.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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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