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GSK BHR Study (Sont - Second Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01324362
First received: February 3, 2011
Last updated: August 31, 2016
Last verified: August 2016
  Purpose
The purpose of this study was to determine whether asthma control and reduced bronchial responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma

Condition Intervention Phase
Asthma
Drug: Placebo
Drug: FP 100mcg
Drug: FP 250mcg
Drug: FP 500mcg
Drug: FSC 100/50mcg
Drug: FSC 250/50mcg
Drug: FSC500/50mcg
Phase 4

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: A Multicenter, Randomized, Double-blind, Parallel Group, 40-week Comparison of Asthma Control Using Bronchial Hyperresponsiveness as an Additional Guide to Long-term Treatment in Adolescents and Adults Receiving Either Fluticasone Propionate/Sameterol DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo Twice Daily if Asymptomatic)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Average ICS treatment dose over the treatment period [ Time Frame: Every 8 weeks through 40 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary function measures [ Time Frame: Every 8 weeks through 40 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 446
Study Start Date: January 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluticasone propionate Drug: Placebo
Twice daily dosing
Other Names:
  • FP 100mcg
  • FP 250mcg
  • FP 500mcg
Drug: FP 100mcg
Twice daily dosing
Drug: FP 250mcg
Twice daily dosing
Drug: FP 500mcg
Twice daily dosing
Active Comparator: Fluticasone propionate/salmeterol combination Drug: Placebo
Twice daily dosing
Drug: FSC 100/50mcg
Twice daily dosing
Drug: FSC 250/50mcg
Twice daily dosing
Drug: FSC500/50mcg
Twice daily dosing

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of asthma
  • Controller asthma medication or medium dose ICS
  • Current or historical reversibility

Exclusion Criteria:

  • Life-threatening asthma
  • Asthma instability
  • Concurrent respiratory disease
  • Drug allergies
  • Respiratory tract infection
  • Systemic corticosteroid use
  • Immunosuppressive medication use
  • Postive pregnancy test
  • Tobacco use
  • Investigation medication use
  • Site affiliation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324362

  Show 57 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Stauffer JL, Yancey SW, Baitinger LA, Prillaman BA, Dorinsky PM. Measuring airway hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Proc Am Thorac Soc 2006;3:A213

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: SAM40065
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: SAM40065
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: SAM40065
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: SAM40065
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: SAM40065
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SAM40065
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SAM40065
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01324362     History of Changes
Other Study ID Numbers: SAM40065 
Study First Received: February 3, 2011
Last Updated: August 31, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
FP
Asthma
Sont
FSC
BHR

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 28, 2016