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Protocol Summary for 112376

Protocol Summary
Protocol Id: 112376
Secondary Ids:
  • None
Title: Study of salmeterol (SN408D) for adult asthma – Clinical study of salmeterol compared with Hokunalin (tulobuterol) tape –
Phase: Phase 4
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: interventional
Oversight Authority:
  • Japan: Ministry of Health, Labour and Welfare
Collaborators:
  • N/A
Brief 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.
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: September 2003
Study Completion Date: February 2005
Study Completion Date Type: Actual
Primary Completion Date: February 2005
Primary Completion Date Type: Actual
Primary Purpose: Treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: yes
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Change in morning PEF no 8 week
Secondary Outcomes:
  • Use of short acting beta agonist no 8 week
  • Adverse event yes 8 week
  • Evening PEF no 8 week
  • Symptom score no 8 week
Conditions:
  • Asthma
Keywords:
  • Long acting beta2-agonist
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 15 years
Maximum Age: N/A
Enrollment: 367
Enrollment Type: Actual
Healthy Volunteers?: No
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.