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Best African American Response to Asthma Drugs

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Flovent Diskus® 100 mcg (Drug); Flovent Diskus® 250 mcg (Drug); Flovent Diskus® 500 mcg (Drug); Advair Diskus® 100/50 mcg (Drug); Advair Diskus® 250/50 mcg (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Milton S. Hershey Medical Center

Official(s) and/or principal investigator(s):
William Busse, MD, Study Chair, Affiliation: University of Wisconsin, Madison

Overall contact:
David Mauger, PhD, Email: dtm5@psu.edu

Summary

The purpose of this study is to find the best asthma treatment to add for Blacks who have asthma that is not well controlled on a low dose of inhaled steroid. This study will also try to find out if Black adults and children differ in how they respond to the medications used in this study.

Clinical Details

Official title: Best African American Response to Asthma Drugs

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary outcome is a composite measure that uses exacerbations, asthma control days during the last 12 of 14 weeks of a treatment regimen, and percent predicted FEV1 at the end of a treatment regimen.

Detailed description: BARD is a 66 week prospective, randomized, double-blind, crossover trial in Blacks (individuals who self-report Black ancestry) who have inadequately controlled asthma while taking low-dose inhaled corticosteroids (ICS). BARD will examine the efficacy of increasing the dose of ICS with or without the addition of a long-acting beta agonist (LABA) to determine whether individual patients respond better to one treatment than another and, if so, whether the responses are different for children and adults or if they are related to genetic ancestry.

Eligibility

Minimum age: 5 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Individuals who self-report Black ancestry (with at least 1 Black grandparent). 2. Able to perform reproducible spirometry according to ATS criteria. 3. Clinical history consistent with asthma. 4. Baseline FEV1≥40% of predicted and/or post-bronchodilator FEV1≥40% of predicted. 5. Asthma confirmed either by: (1) Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR (2) PC20FEV1 ≤ 16 mg/ml OR (3) an absolute relative change in %predicted FEV1 of ≥ 12% over two measurements documented by repeat spirogram over the previous year 6. Either: A) inadequately controlled on low-, medium- or high-dose ICS monotherapy, or low- or medium-dose ICS/LABA, or B) well-controlled on medium- or high-dose ICS monotherapy, or low-, medium- or high-dose ICS/LABA. Inadequate asthma control will be defined as an ACT/c-ACT score <20; well-controlled asthma will be defined as an ACT/c-ACT score ≥20. 7. Stable asthma controller therapy dose (ICS or ICS/LABA) for the 2 weeks prior to enrollment. 8. Non-smoker (total lifetime smoking history < 5 pack-years if <18, or <10 pack-years if ≥18 years of age; no smoking for at least 1 year). 9. For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent. Exclusion Criteria: 1. Medical contraindication to LABA or history of adverse reactions to ICS or LABA preparations or any of their ingredients. 2. Current or prior use of medications known to significantly interact with corticosteroid disposition within the two-week period preceding enrollment. 3. Unwilling to provide a blood sample for DNA extraction and genetic analysis. 4. Major medical problems prohibiting study participation, i. e. presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study or that would place the participant at increased risk. 5. Systemic corticosteroid treatment for any condition within 4 weeks of enrollment or more than five courses of systemic corticosteroids in the past year. 6. History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years. 7. History of a respiratory tract infection within 4 weeks of enrollment. 8. If a female of child-bearing potential, failure to practice abstinence or use an acceptable birth control method. 9. Pregnancy or lactation or planning to get pregnant during the course of the trial. 10. Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment. 11. Participation in an intervention trial or use of investigative drugs in the past 30 days or plans to enroll in such a trial during the study.

Locations and Contacts

David Mauger, PhD, Email: dtm5@psu.edu

University of Arizona College of Medicine, Tucson, Arizona 85724, United States; Recruiting

Children's Hospital & Research Center Oakland, Oakland, California 94609, United States; Recruiting

UCSF Benioff Children's Hospital, San Francisco, California 94143, United States; Recruiting

University of California - San Francisco, San Francisco, California 94143, United States; Recruiting

National Jewish Health, Denver, Colorado 80206, United States; Recruiting

Nemours Children's Clinic, Jacksonville, Florida 32207, United States; Recruiting

Nemours Children's Clinic, Orlando, Florida 32827, United States; Recruiting

Emory University, Atlanta, Georgia 30322, United States; Recruiting

Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois 60614, United States; Recruiting

Northwestern Memorial Hospital, Chicago, Illinois 60611, United States; Recruiting

Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting

University of Chicago, Chicago, Illinois 60637, United States; Recruiting

University of Illinois at Chicago, Chicago, Illinois 60612, United States; Recruiting

Brigham & Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting

Children's Hospital Boston, Boston, Massachusetts 02115, United States; Recruiting

St. Louis Children's Hospital, St. Louis, Missouri 63110, United States; Recruiting

Washington University, St. Louis, Missouri 63110, United States; Recruiting

University of New Mexico, Albuquerque, New Mexico 87131, United States; Recruiting

Columbia University Medical Center, New York, New York 10032, United States; Recruiting

Duke University School of Medicine, Durham, North Carolina 27110, United States; Recruiting

North Carolina Clinical Research, Raleigh, North Carolina 27607, United States; Recruiting

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting

Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, Ohio 44106, United States; Recruiting

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States; Recruiting

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15224, United States; Recruiting

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States; Recruiting

University of Wisconsin-Madison, Madison, Wisconsin 53792, United States; Recruiting

Center for Urban Population Health, Milwaukee, Wisconsin 53223, United States; Recruiting

Additional Information

AsthmaNet

Starting date: February 2014
Last updated: April 22, 2015

Page last updated: August 23, 2015

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