SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)

The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.

Completed

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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

15 year–80 year

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

Patient is currently a nonsmoker and has been a nonsmoker for at least 1 year
Patient with clinical evidence of mild/moderate asthma with or without allergic rhinitis

Exclusion criteria

Patient has been treated in an emergency room for asthma within 4 weeks or has been hospitalized for asthma within 3 months prior to visit 1
Patient with severe asthma, upper respiratory infection, sinusitis, infectious rhinitis, non-allergic rhinitis
Patient has any active, acute, or chronic pulmonary disorder that is documented by history, physical examination

Treatment and study plan

MK0476, montelukast sodium / Duration of Treatment: 8 Weeks

Drug

Primary outcomes

Change of the asthma control questionnaire scores taken over 8 weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

An Open Label, Observational Study to Assess The Efficacy, Safety and Tolerability of Added Singulair in Persistent Asthma Patients With or Without Allergic Rhinitis and Long Acting B-Agonist

Acronym: STAR

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Mar 8, 2007
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.

Published trials that share one or more normalized conditions with this study.

Completed