Singulair(R) In Asthma And Allergic Rhinitis (0476-383)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-01

Study Completion Date

2008-01-01

Brief Summary

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Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

montelukast sodium

Group Type EXPERIMENTAL

montelukast sodium

Intervention Type DRUG

montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment

Interventions

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montelukast sodium

montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment

Intervention Type DRUG

Other Intervention Names

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Singulair

Eligibility Criteria

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Inclusion Criteria

* Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (ICS/LABA) at any dosage
* Peak expiratory flow is \> or = 80% of predicted value on the day of visit 1
* Uncontrolled as per Canadian asthma consensus guidelines

Exclusion Criteria

* Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms
* Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No