Best African American Response to Asthma Drugs

Completed · Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01967173

Run by

Milton S. Hershey Medical Center

People needed

574

Starts

2014-02-01

Expected to finish

2017-07-01

Last updated by the study team

2018-11-15

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals who self-report Black ancestry (with at least 1 Black grandparent).
• Able to perform reproducible spirometry according to ATS criteria.
• Clinical history consistent with asthma.
• Baseline FEV1≥40% of predicted and/or post-bronchodilator FEV1≥40% of predicted.
• 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
• 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.
• Stable asthma controller therapy dose (ICS or ICS/LABA) for the 2 weeks prior to enrollment.
• 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).
• 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.

You may not qualify if…

• Medical contraindication to LABA or history of adverse reactions to ICS or LABA preparations or any of their ingredients.
• Current or prior use of medications known to significantly interact with corticosteroid disposition within the two-week period preceding enrollment.
• Unwilling to provide a blood sample for DNA extraction and genetic analysis.
• 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.
• Systemic corticosteroid treatment for any condition within 4 weeks of enrollment or more than five courses of systemic corticosteroids in the past year.
• History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years.
• History of a respiratory tract infection within 4 weeks of enrollment.
• If a female of child-bearing potential, failure to practice abstinence or use an acceptable birth control method.
• Pregnancy or lactation or planning to get pregnant during the course of the trial.
• Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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