GSK BHR Study (Sont - Second Study) - Full Text View

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 Intervention Model: Parallel Assignment Masking: Double Blind (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)

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:

Pulmonary function measures [ Time Frame: Every 8 weeks through 40 weeks of treatment ]


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)
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

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:

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

This link exits the ClinicalTrials.gov site

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