GSK BHR Study (Sont - Second Study)

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01324362

First received: February 3, 2011

Last updated: October 13, 2011

Last verified: October 2011

History of Changes

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/Salmeterol DISKUSTM BID or Fluticasone Propionate DISK ...

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

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
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 51 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

No publications provided


Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01324362 History of Changes
Other Study ID Numbers:	SAM40065
Study First Received:	February 3, 2011
Last Updated:	October 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:


FP Asthma Sont FSC BHR

Additional relevant MeSH terms:


Fluticasone Anti-Allergic Agents Anti-Asthmatic Agents Anti-Inflammatory Agents Autonomic Agents Bronchodilator Agents	Dermatologic Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Respiratory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

To Top