NCT00950794

Study of Salmeterol (SN408D) for Adult Asthma

Study of Salmeterol (SN408D) for Adult Asthma - Clinical Study of Salmeterol Compared With Hokunalin (Tulobuterol) Tape -

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the efficacy (non-inferiority) of Salmeterol 50mcg bid (100mcg/day), compared with Hokunalin (tulobuterol) tape 2mg once a day, in terms of improvement in pulmonary function (peak expiratory flow: PEF) in a randomized, double-blind, parallel-group comparative study in adult patients with bronchial asthma on ICS 400mcg/day of FP equivalent.

Detailed description

Primary To demonstrate the efficacy (non-inferiority) of Salmeterol 50mcg bid (100mcg/day), compared with Hokunalin (tulobuterol) tape 2mg once a day, in terms of improvement in pulmonary function (peak expiratory flow: PEF) in a randomized, double-blind, parallel-group comparative study in adult patients with bronchial asthma on ICS 400mcg/day of FP equivalent. Secondary * To evaluate the efficacy of Salmeterol , compared with Hokunalin (tulobuterol) tape in terms of asthma symptoms recorded in the asthma diary. * To evaluate the safety of Serevent compared with Hokunalin (tulobuterol) tape.

Conditions

• Asthma
• Bronchial Asthma

Interventions

Type	Name	Description
DRUG	Salmeterol(SN408D)	Salmeterol(SN408D)：long-acting Beta2-agonist
DRUG	Hokunalin (tulobuterol) tape	Hokunalin (tulobuterol) tape:long-acting Beta2-agonist

Timeline

• Start date: 2003-09-01
• Primary completion: 2005-02-01
• Completion: 2005-02-01
• First posted: 2009-08-03
• Last updated: 2009-08-07