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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00445107

Acronym

STAR

Enrollment

198

Registered

2007-03-08

Start date

2005-11-01

Completion date

2006-05-17

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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.

Interventions

DRUGMK0476, montelukast sodium / Duration of Treatment: 8 Weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change of the asthma control questionnaire scores taken over 8 weeks	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026