Study of Salmeterol (SN408D) for Adult Asthma
|Asthma Bronchial Asthma||Drug: Salmeterol(SN408D) Drug: Hokunalin (tulobuterol) tape||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Study of Salmeterol (SN408D) for Adult Asthma - Clinical Study of Salmeterol Compared With Hokunalin (Tulobuterol) Tape -|
- Change in morning PEF [ Time Frame: 8 week ]
- Use of short acting beta agonist [ Time Frame: 8 week ]
- Adverse event [ Time Frame: 8 week ]
- Evening PEF [ Time Frame: 8 week ]
- Symptom score [ Time Frame: 8 week ]
|Study Start Date:||September 2003|
|Study Completion Date:||February 2005|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
Active Comparator: Hokunalin(tulobuterol) tape
Hokunalin(tulobuterol) tape: long-acting Beta2-agonist
Drug: Hokunalin (tulobuterol) tape
Hokunalin (tulobuterol) tape:long-acting Beta2-agonist
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950794
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|