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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00950794 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma Bronchial Asthma |
Drug: Salmeterol(SN408D) Drug: Hokunalin (tulobuterol) tape |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Study of Salmeterol (SN408D) for Adult Asthma - Clinical Study of Salmeterol Compared With Hokunalin (Tulobuterol) Tape - |
| Enrollment: | 367 |
| Study Start Date: | September 2003 |
| Study Completion Date: | February 2005 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Hokunalin(tulobuterol) tape
Hokunalin(tulobuterol) tape: long-acting Beta2-agonist
|
Drug: Hokunalin (tulobuterol) tape
Hokunalin (tulobuterol) tape:long-acting Beta2-agonist
|
|
Experimental: Salmeterol(408DP-02)
Salmeterol(408DP-02):long-acting Beta2-agonist
|
Drug: Salmeterol(SN408D)
Salmeterol(SN408D):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.
Secondary
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
Subjects who are able to give a written informed consent to participation in the study.
However, if a subject is aged < 20 years at the time of giving informed consent, a written informed consent should be obtained from the subject and his/her legally acceptable representative.
Subjects who have been receiving ICS 400mcg/day of FP equivalent for at least 8 weeks prior to Visit 1.
A subject will be considered eligible for entering the treatment period only if he/she completes the run-in period and meets all of the following criteria:
Subjects who meet both of the following criteria in terms of pulmonary function.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply at Visit 1 or Visit 2:
Subjects who are regularly using medications containing the following ingredients:
beta-blockers, alpha/beta-blockers
Contacts and Locations
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00950794 History of Changes |
| Other Study ID Numbers: | 112376 |
| Study First Received: | July 30, 2009 |
| Last Updated: | August 6, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Long acting beta2-agonist |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Terbutaline Tulobuterol Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Sympathomimetics Tocolytic Agents Reproductive Control Agents |