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Best African American Response to Asthma Drugs (BARD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01967173
Recruitment Status : Completed
First Posted : October 22, 2013
Results First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: 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 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 574 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Best African American Response to Asthma Drugs
Study Start Date : February 2014
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fluticasone

Arm Intervention/treatment
Experimental: Crossover sequence 1
Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg
Drug: Flovent Diskus® 100 mcg
Flovent is an ICS

Drug: Flovent Diskus® 250 mcg
Flovent is an ICS

Drug: Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination

Drug: Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination

Experimental: Crossover sequence 2
Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg
Drug: Flovent Diskus® 100 mcg
Flovent is an ICS

Drug: Flovent Diskus® 250 mcg
Flovent is an ICS

Drug: Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination

Drug: Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination

Experimental: Crossover sequence 3
Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg
Drug: Flovent Diskus® 100 mcg
Flovent is an ICS

Drug: Flovent Diskus® 250 mcg
Flovent is an ICS

Drug: Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination

Drug: Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination

Experimental: Crossover sequence 4
Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg
Drug: Flovent Diskus® 100 mcg
Flovent is an ICS

Drug: Flovent Diskus® 250 mcg
Flovent is an ICS

Drug: Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination

Drug: Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination

Experimental: Crossover sequence 5
Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg
Drug: Flovent Diskus® 250 mcg
Flovent is an ICS

Drug: Flovent Diskus® 500 mcg
Flovent is an ICS

Drug: Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination

Drug: Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination

Experimental: Crossover sequence 6
Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg
Drug: Flovent Diskus® 250 mcg
Flovent is an ICS

Drug: Flovent Diskus® 500 mcg
Flovent is an ICS

Drug: Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination

Drug: Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination

Experimental: Crossover sequence 7
Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg
Drug: Flovent Diskus® 250 mcg
Flovent is an ICS

Drug: Flovent Diskus® 500 mcg
Flovent is an ICS

Drug: Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination

Drug: Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination

Experimental: Crossover sequence 8
Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg
Drug: Flovent Diskus® 250 mcg
Flovent is an ICS

Drug: Flovent Diskus® 500 mcg
Flovent is an ICS

Drug: Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination

Drug: Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination




Primary Outcome Measures :
  1. 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. [ Time Frame: The last 12 weeks of each 14-week treatment period ]
    This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT01967173


  Hide Study Locations
Locations
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United States, Arizona
University of Arizona College of Medicine
Tucson, Arizona, United States, 85724
United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94143
University of California - San Francisco
San Francisco, California, United States, 94143
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic
Orlando, Florida, United States, 32827
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, United States, 60614
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Washington University
Saint Louis, Missouri, United States, 63110
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27110
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Center for Urban Population Health
Milwaukee, Wisconsin, United States, 53223
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Study Chair: William Busse, MD University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by dave mauger, Milton S. Hershey Medical Center:

Additional Information:
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Responsible Party: dave mauger, Principal Investigator, AsthmaNet Data Coordinating Center, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01967173     History of Changes
Other Study ID Numbers: AsthmaNet 006
1U10HL098115 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2013    Key Record Dates
Results First Posted: November 15, 2018
Last Update Posted: November 15, 2018
Last Verified: October 2018
Keywords provided by dave mauger, Milton S. Hershey Medical Center:
Asthma
Fluticasone
Salmeterol
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Fluticasone-Salmeterol Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents