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GSK BHR Study (Sont - Second Study)

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ClinicalTrials.gov Identifier: NCT01324362
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : January 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Average ICS treatment dose over the treatment period [ Time Frame: Every 8 weeks through 40 weeks of treatment ]

Secondary Outcome Measures :
  1. Pulmonary function measures [ Time Frame: Every 8 weeks through 40 weeks of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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): NCT01324362


  Show 57 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.  This link exits the ClinicalTrials.gov site

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

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01324362     History of Changes
Other Study ID Numbers: SAM40065
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
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