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The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)

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ClinicalTrials.gov Identifier: NCT00739297
Recruitment Status : Completed
First Posted : August 21, 2008
Results First Posted : April 9, 2010
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.

Condition or disease Intervention/treatment Phase
Chronic Asthma Drug: Comparator: montelukast Drug: Comparator: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma
Study Start Date : July 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
montelukast Placebo
Drug: Comparator: montelukast
5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
Other Name: SINGULAIR®, PROAIR® HFA
Drug: Comparator: placebo
5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
Experimental: 2
montelukast
Drug: Comparator: montelukast
5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
Other Name: SINGULAIR®, PROAIR® HFA
Experimental: 3
montelukast
Drug: Comparator: montelukast
5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
Other Name: SINGULAIR®, PROAIR® HFA
Experimental: 4
montelukast
Drug: Comparator: montelukast
5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
Other Name: SINGULAIR®, PROAIR® HFA



Primary Outcome Measures :
  1. Change From Baseline in FEV1 Over 4 Hours [ Time Frame: 0 (=baseline) to 4 hours after treatment with montelukast ]
    FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.


Secondary Outcome Measures :
  1. Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration [ Time Frame: 4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast ]
    FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.


Other Outcome Measures:
  1. Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast [ Time Frame: 0 (baseline) and 8 hours after treatment with montelukast ]
    Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.

  2. Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast [ Time Frame: 0 (baseline) and 24 hours after treatment with montelukast ]
    Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A person is 15 to 65 years of age. A person has had chronic asthma for at least one year

Exclusion Criteria:

  • A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping
  • A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739297


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00739297     History of Changes
Other Study ID Numbers: 0476-388
MK0476-388
2008_542
First Posted: August 21, 2008    Key Record Dates
Results First Posted: April 9, 2010
Last Update Posted: April 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Keywords provided by Merck Sharp & Dohme Corp.:
Chronic asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action