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

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ClinicalTrials.gov Identifier: NCT00092144
Recruitment Status : Completed
First Posted : September 24, 2004
Last Update Posted : September 15, 2017
Sponsor:
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00092144


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

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092144     History of Changes
Other Study ID Numbers: 0476-289
2004_028
First Posted: September 24, 2004    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

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