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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

Tracking Information
First Submitted Date  ICMJE October 11, 2013
First Posted Date  ICMJE October 22, 2013
Results First Submitted Date  ICMJE September 10, 2018
Results First Posted Date  ICMJE November 15, 2018
Last Update Posted Date November 15, 2018
Study Start Date  ICMJE February 2014
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2013)
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 change in percent predicted FEV1 over the last 12 weeks 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 change in percent predicted FEV1 over the last 12 weeks of a treatment period. If one treatment yields at least 5% greater change in FEV1 than another, it is deemed the superior treatment. If treatment superiority can be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.
Change History Complete list of historical versions of study NCT01967173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Best African American Response to Asthma Drugs
Official Title  ICMJE Best African American Response to Asthma Drugs
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Flovent Diskus® 100 mcg
    Flovent is an ICS
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Flovent Diskus® 100 mcg
    • Drug: Flovent Diskus® 250 mcg
    • Drug: Advair Diskus® 100/50 mcg
    • Drug: Advair Diskus® 250/50 mcg
  • 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
    Interventions:
    • Drug: Flovent Diskus® 100 mcg
    • Drug: Flovent Diskus® 250 mcg
    • Drug: Advair Diskus® 100/50 mcg
    • Drug: Advair Diskus® 250/50 mcg
  • 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
    Interventions:
    • Drug: Flovent Diskus® 100 mcg
    • Drug: Flovent Diskus® 250 mcg
    • Drug: Advair Diskus® 100/50 mcg
    • Drug: Advair Diskus® 250/50 mcg
  • 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
    Interventions:
    • Drug: Flovent Diskus® 100 mcg
    • Drug: Flovent Diskus® 250 mcg
    • Drug: Advair Diskus® 100/50 mcg
    • Drug: Advair Diskus® 250/50 mcg
  • 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
    Interventions:
    • Drug: Flovent Diskus® 250 mcg
    • Drug: Flovent Diskus® 500 mcg
    • Drug: Advair Diskus® 100/50 mcg
    • Drug: Advair Diskus® 250/50 mcg
  • 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
    Interventions:
    • Drug: Flovent Diskus® 250 mcg
    • Drug: Flovent Diskus® 500 mcg
    • Drug: Advair Diskus® 100/50 mcg
    • Drug: Advair Diskus® 250/50 mcg
  • 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
    Interventions:
    • Drug: Flovent Diskus® 250 mcg
    • Drug: Flovent Diskus® 500 mcg
    • Drug: Advair Diskus® 100/50 mcg
    • Drug: Advair Diskus® 250/50 mcg
  • 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
    Interventions:
    • Drug: Flovent Diskus® 250 mcg
    • Drug: Flovent Diskus® 500 mcg
    • Drug: Advair Diskus® 100/50 mcg
    • Drug: Advair Diskus® 250/50 mcg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2017)
574
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2013)
494
Actual Study Completion Date  ICMJE July 1, 2017
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01967173
Other Study ID Numbers  ICMJE AsthmaNet 006
1U10HL098115 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party dave mauger, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Study Chair: William Busse, MD University of Wisconsin, Madison
PRS Account Milton S. Hershey Medical Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP