Asthma Clinical Trial
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 DISKUS Twice Daily or Fluticasone Propionate DISKUS Twice Daily (or Placebo BID if Asymptomatic)
| Verified date | August 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 464 |
| Est. completion date | October 2004 |
| Est. primary completion date | October 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | GSK Investigational Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | GSK Investigational Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | GSK Investigational Site | Salvador | Bahía |
| Latvia | GSK Investigational Site | Riga | |
| Latvia | GSK Investigational Site | Riga | |
| Puerto Rico | GSK Investigational Site | Ponce | |
| United States | GSK Investigational Site | Absecon | New Jersey |
| United States | GSK Investigational Site | Asheville | North Carolina |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Bay Pines | Florida |
| United States | GSK Investigational Site | Bellingham | Washington |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Butte | Montana |
| United States | GSK Investigational Site | Canton | Ohio |
| United States | GSK Investigational Site | Carmichael | California |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Charlottesville | Virginia |
| United States | GSK Investigational Site | Cherry Hill | New Jersey |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Gainesville | Florida |
| United States | GSK Investigational Site | Hartford | Connecticut |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Iowa City | Iowa |
| United States | GSK Investigational Site | Lafayette | Indiana |
| United States | GSK Investigational Site | Lincoln | Rhode Island |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Medford | Oregon |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | Morgantown | West Virginia |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | Normal | Illinois |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Palmdale | California |
| United States | GSK Investigational Site | Papillion | Nebraska |
| United States | GSK Investigational Site | Petoskey | Michigan |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Rockville Center | New York |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Jose | California |
| United States | GSK Investigational Site | San Jose | California |
| United States | GSK Investigational Site | Sarasota | Florida |
| United States | GSK Investigational Site | Statesville | North Carolina |
| United States | GSK Investigational Site | Sylvania | Ohio |
| United States | GSK Investigational Site | Tigard | Oregon |
| United States | GSK Investigational Site | Toledo | Ohio |
| United States | GSK Investigational Site | Trumbull | Connecticut |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | Wheat Ridge | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Brazil, Latvia, Puerto Rico,
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Average inhaled corticosteroid treatment dose over the treatment period | Every 8 weeks for the 40 week treatment period | No | |
| Secondary | Pulmonary function measures | Every 8 weeks for the 40 week treatment period | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
| Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
| Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
| Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
| Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
| Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
| Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
| Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
| Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
| Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
| Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
| Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
| Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
| Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
| Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
| Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
| Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
| Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|