A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)

NCT ID: NCT00140946

Last Updated: 2022-02-02

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

PHASE4

Total Enrollment

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-03-31

Study Completion Date

2000-10-31

Brief Summary

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A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.

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: 16 weeks

Intervention Type DRUG

Comparator: placebo / Duration of Treatment: 16 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females between the ages of 18 and 70 with asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Vaquerizo MJ, Casan P, Castillo J, Perpina M, Sanchis J, Sobradillo V, Valencia A, Verea H, Viejo JL, Villasante C, Gonzalez-Esteban J, Picado C; CASIOPEA (Capacidad de Singulair Oral en la Prevencion de Exacerbaciones Asmaticas) Study Group. Effect of montelukast added to inhaled budesonide on control of mild to moderate asthma. Thorax. 2003 Mar;58(3):204-10. doi: 10.1136/thorax.58.3.204.

Reference Type RESULT
PMID: 12612294 (View on PubMed)

Other Identifiers

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MK0476-075

Identifier Type: -

Identifier Source: secondary_id

2005_057

Identifier Type: -

Identifier Source: secondary_id

0476-075

Identifier Type: -

Identifier Source: org_study_id

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