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Completed

NCT Number: NCT00092144

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Asthma symptoms brought on by allergies

Exclusion criteria

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

Treatment and study plan

MK0476, montelukast sodium / Duration of Treatment: 4 Weeks

Drug

Comparator: placebo / Duration of Treatment: 4 weeks

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Sep 24, 2004
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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