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
|
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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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Fluticasone propionate |
Drug: Placebo
Twice daily dosing
Other Names:
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
|
- Average ICS treatment dose over the treatment period [ Time Frame: Every 8 weeks through 40 weeks of treatment ]
- Pulmonary function measures [ Time Frame: Every 8 weeks through 40 weeks of treatment ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
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 |