Best African American Response to Asthma Drugs

Asthma Clinical Trial

— BARD  

Official title:

Best African American Response to Asthma Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967173
• Other study ID #: AsthmaNet 006
• Secondary ID: 1U10HL098115
• Status: Completed
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: July 1, 2017

Study information

• Verified date: October 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Flovent Diskus® 100 mcg
Flovent is an ICS
• 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

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Ann and Robert H. Lurie Children's Hospital	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Rainbow Babies and Children's Hospital, Case Western Reserve University	Cleveland	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Duke University School of Medicine	Durham	North Carolina
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Center for Urban Population Health	Milwaukee	Wisconsin
United States	Columbia University Medical Center	New York	New York
United States	Children's Hospital & Research Center Oakland	Oakland	California
United States	Nemours Children's Clinic	Orlando	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	University of California - San Francisco	San Francisco	California
United States	University of Arizona College of Medicine	Tucson	Arizona
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	The last 12 weeks of each 14-week treatment period

External Links

•   AsthmaNet