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

NCT ID: NCT00092144

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-26

Study Completion Date

2004-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0476, montelukast sodium / Duration of Treatment: 4 weeks

Intervention Type DRUG

Comparator: placebo / Duration of Treatment: 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Asthma symptoms brought on by allergies

Exclusion Criteria

* Patient has any lung disease
* Currently have a sinus infection or cold symptoms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Busse WW, Casale TB, Dykewicz MS, Meltzer EO, Bird SR, Hustad CM, Grant E, Zeldin RK, Edelman JM. Efficacy of montelukast during the allergy season in patients with chronic asthma and seasonal aeroallergen sensitivity. Ann Allergy Asthma Immunol. 2006 Jan;96(1):60-8. doi: 10.1016/S1081-1206(10)61041-1.

Reference Type BACKGROUND
PMID: 16440534 (View on PubMed)

Other Identifiers

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2004_028

Identifier Type: -

Identifier Source: secondary_id

0476-289

Identifier Type: -

Identifier Source: org_study_id

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