Study of Salmeterol (SN408D) for Adult Asthma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00950794|
Recruitment Status : Completed
First Posted : August 3, 2009
Last Update Posted : August 7, 2009
|Condition or disease||Intervention/treatment||Phase|
|Asthma Bronchial Asthma||Drug: Salmeterol(SN408D) Drug: Hokunalin (tulobuterol) tape||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||367 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Study of Salmeterol (SN408D) for Adult Asthma - Clinical Study of Salmeterol Compared With Hokunalin (Tulobuterol) Tape -|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||February 2005|
|Actual Study Completion Date :||February 2005|
Active Comparator: Hokunalin(tulobuterol) tape
Hokunalin(tulobuterol) tape: long-acting Beta2-agonist
Drug: Hokunalin (tulobuterol) tape
Hokunalin (tulobuterol) tape:long-acting Beta2-agonist
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950794
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|