Overview

This trial is active, not recruiting.

Condition asthma
Treatments flovent diskus® 100 mcg, flovent diskus® 250 mcg, flovent diskus® 500 mcg, advair diskus® 100/50 mcg, advair diskus® 250/50 mcg
Phase phase 3
Sponsor Milton S. Hershey Medical Center
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date February 2014
End date July 2017
Trial size 544 participants
Trial identifier NCT01967173, 1U10HL098115, AsthmaNet 006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg
flovent diskus® 100 mcg
Flovent is an ICS
flovent diskus® 250 mcg
Flovent is an ICS
advair diskus® 100/50 mcg
Advair is an ICS/LABA combination
advair diskus® 250/50 mcg
Advair is an ICS/LABA combination
(Experimental)
Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg
flovent diskus® 100 mcg
Flovent is an ICS
flovent diskus® 250 mcg
Flovent is an ICS
advair diskus® 100/50 mcg
Advair is an ICS/LABA combination
advair diskus® 250/50 mcg
Advair is an ICS/LABA combination
(Experimental)
Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg
flovent diskus® 100 mcg
Flovent is an ICS
flovent diskus® 250 mcg
Flovent is an ICS
advair diskus® 100/50 mcg
Advair is an ICS/LABA combination
advair diskus® 250/50 mcg
Advair is an ICS/LABA combination
(Experimental)
Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg
flovent diskus® 100 mcg
Flovent is an ICS
flovent diskus® 250 mcg
Flovent is an ICS
advair diskus® 100/50 mcg
Advair is an ICS/LABA combination
advair diskus® 250/50 mcg
Advair is an ICS/LABA combination
(Experimental)
Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg
flovent diskus® 250 mcg
Flovent is an ICS
flovent diskus® 500 mcg
Flovent is an ICS
advair diskus® 100/50 mcg
Advair is an ICS/LABA combination
advair diskus® 250/50 mcg
Advair is an ICS/LABA combination
(Experimental)
Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg
flovent diskus® 250 mcg
Flovent is an ICS
flovent diskus® 500 mcg
Flovent is an ICS
advair diskus® 100/50 mcg
Advair is an ICS/LABA combination
advair diskus® 250/50 mcg
Advair is an ICS/LABA combination
(Experimental)
Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg
flovent diskus® 250 mcg
Flovent is an ICS
flovent diskus® 500 mcg
Flovent is an ICS
advair diskus® 100/50 mcg
Advair is an ICS/LABA combination
advair diskus® 250/50 mcg
Advair is an ICS/LABA combination
(Experimental)
Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg
flovent diskus® 250 mcg
Flovent is an ICS
flovent diskus® 500 mcg
Flovent is an ICS
advair diskus® 100/50 mcg
Advair is an ICS/LABA combination
advair diskus® 250/50 mcg
Advair is an ICS/LABA combination

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 5 years old.

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.

Additional Information

Official title Best African American Response to Asthma Drugs
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Milton S. Hershey Medical Center.