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

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: MK0476, montelukast sodium / Duration of Treatment: 8 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00445107

0476-363

2007_002

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)