Best African American Response to Asthma Drugs (BARD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Milton S. Hershey Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01967173
First received: October 11, 2013
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Best African American Response to Asthma Drugs

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 494
Study Start Date: February 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crossover sequence 1
Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 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 2
Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 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 3
Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 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 4
Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 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 5
Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 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 6
Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 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
Experimental: Crossover sequence 7
Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 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 8
Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 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

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

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967173

Contacts
Contact: David Mauger, PhD dtm5@psu.edu

  Show 28 Study Locations
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Study Chair: William Busse, MD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

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
Study First Received: October 11, 2013
Last Updated: August 29, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Asthma
Fluticasone
Salmeterol

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014