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GSK BHR Study (Sont)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Placebo (Drug); FP 100mcg (Drug); FP 500mcg (Drug); FP 250mcg (Drug); FSC 100/50mcg (Drug); FSC 250/50mcg (Drug); FSC 500/50mcg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

The purpose of this study was to determine whether asthma control and reduced bronchial hyperresponsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS twice-daily or FP twice-daily in adult and adolescent subjects with persistent asthma

Clinical Details

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 ...

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Average inhaled corticosteroid treatment dose over the treatment period

Secondary outcome: Pulmonary function measures

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Asthma diagnosis

- Controller medications or moderate inhaled corticosteroid dose

- Evidence of reversibility

Exclusion Criteria:

- Life-threatening asthma

- Asthma instability

- Concurrent respiratory disease

- Drug allergy

- Respiratory tract infection

- Systemic corticosteroid use

- Immunosuppressive medication use

- Positive pregnancy test

- Tobacco use

- Site affiliation

Locations and Contacts

GSK Investigational Site, Birmingham, Alabama 35209, United States

GSK Investigational Site, Bay Pines, Florida 33744, United States

GSK Investigational Site, Statesville, North Carolina 28625, United States

GSK Investigational Site, Tigard, Oregon 97223, United States

GSK Investigational Site, Bellingham, Washington 98226, United States

Additional Information

Related publications:

Koenig SM, Murray JJ, Wolfe J, Andersen L, Yancey S, Prillaman B, Stauffer J, Dorinsky P. Does measuring BHR add to guideline derived clinical measures in determining treatment for patients with persistent asthma? Respir Med. 2008 May;102(5):665-73. doi: 10.1016/j.rmed.2007.12.023. Epub 2008 Mar 6.

Dorinsky P, Yancey S, Baitinger L, Stauffer J. Measuring Airway Hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Eur Respir J 2006;28(50):319s.

Kerwin EM, Nathan RA, Meltzer EO, Ortega HG, Yancey SW, Schoaf L, Dorinsky PM. Efficacy and safety of fluticasone propionate/salmeterol 250/50 mcg Diskus administered once daily. Respir Med. 2008 Apr;102(4):495-504. doi: 10.1016/j.rmed.2007.12.002. Epub 2008 Feb 21.

Starting date: February 2003
Last updated: April 11, 2013

Page last updated: August 20, 2015

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