Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00092144
Recruitment Status : Completed
First Posted : September 24, 2004
Last Update Posted : September 15, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.

Condition or disease Intervention/treatment Phase
Asthma Drug: MK0476, montelukast sodium / Duration of Treatment: 4 weeks Drug: Comparator: placebo / Duration of Treatment: 4 weeks Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral MK0476 Vs Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season
Actual Study Start Date : February 26, 2004
Actual Primary Completion Date : June 15, 2004
Actual Study Completion Date : June 15, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Primary Outcome Measures :
  1. To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period

Secondary Outcome Measures :
  1. To assess the following over a 3-week treatment period:
  2. nighttime symptoms
  3. AM PEFR
  4. PM PEFR
  5. B-agonist use
  6. asthma attacks
  7. discontinuations due to asthma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Asthma symptoms brought on by allergies

Exclusion Criteria:

  • Patient has any lung disease
  • Currently have a sinus infection or cold symptoms

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 identifier (NCT number): NCT00092144

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

Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00092144     History of Changes
Other Study ID Numbers: 0476-289
First Posted: September 24, 2004    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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