Exercise Induced Bronchoconstriction - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00664937

Purpose

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.

Condition	Intervention	Phase
Asthma, Exercise-Induced	Drug: montelukast sodium Drug: Comparator: placebo (unspecified)	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	A 3 Period, Double-Blind, Randomized Crossover Study to Evaluate the Effects of a Single Dose of Montelukast Compared With Placebo on Exercise-Induced Bronchoconstriction as Assessed by Hyperpolarized Gas Magnetic Resonance Imaging.

Resource links provided by NLM:

MedlinePlus related topics: Asthma Exercise and Physical Fitness Gas MRI Scans

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reproducability of ventilation volume and ventilation volume defects as measured by 3He MRI [ Time Frame: 3-7 days apart. ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	May 2007
Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Placebo Comparator 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 single oral dose, before exercise challenge, of montelukast 10mg; 7 week duration. Drug: Comparator: placebo (unspecified) single oral dose, before exercise challenge, of Pbo; 7 week duration.
II: Placebo Comparator 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 single oral dose, before exercise challenge, of montelukast 10mg; 7 week duration. Drug: Comparator: placebo (unspecified) single oral dose, before exercise challenge, of Pbo; 7 week duration.
III: Placebo Comparator 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 single oral dose, before exercise challenge, of montelukast 10mg; 7 week duration. Drug: Comparator: placebo (unspecified) single oral dose, before exercise challenge, of Pbo; 7 week duration.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664937

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_502, MK0476-359
Study First Received:	April 22, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00664937 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Pharmacologic Actions

Leukotriene Antagonists
Asthma, Exercise-Induced
Montelukast
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010