Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT) (BELT)
|ClinicalTrials.gov Identifier: NCT01290874|
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : March 30, 2018
Last Update Posted : March 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Tiotropium Drug: Salmeterol Drug: Formoterol||Phase 3|
Asthma is a chronic respiratory disease that affects over 22 million people in the United States. Asthma produces 500,000 hospital admissions and accounts for 10.1 million days of lost work in adults annually. Asthma has been designated a priority condition of the Effective Health Care Program.
Blacks bear a disproportionate burden of asthma morbidity and mortality. In its 2005 report on ethnic disparities in health care, AHRQ identified hospital admissions for asthma as the second largest disparity in quality of health care for Blacks vs. Caucasians.
Long-acting beta-agonists (LABAs) produce extended increases in airway caliber among patients with asthma via action at the beta2-adrenergic receptor (ADRB2). Adding a LABA to an inhaled corticosteroid controller medication (ICS), can decrease asthma symptoms for many individuals and appears to decrease asthma exacerbations. LABA/ICS has become the most commonly prescribed ICS containing medication.
Drugs acting at ADRB2, including LABAs, have been associated with rare loss of long-term asthma control and increased serious adverse outcomes including death and respiratory failure, even when used with ICS. The risk appears four to five-fold greater in Blacks than non-Black patients with asthma.
Consensus guidelines recommend LABAs be added to ICS in those not completely controlled on ICS alone. These recommendations are based on weighing data on the benefit demonstrated in the general population vs. the rare risk of serious adverse outcomes and balancing the apparent benefits vs. the risks of LABAs (Kramer 2009). However, it appears that LABA/ICS may be significantly less effective in Blacks than Caucasians. Comparison of studies with LABA/ICS in Blacks vs. studies where Blacks were a small minority suggests that Blacks may have much less benefit than other racial groups. Additionally, recent data (Wechsler 2009) suggest that a polymorphism at the 16th position of the ADRB2 gene identifies a group of Blacks (those homozygous for arginine (Arg16Arg)) in whom the response of adding a LABA to an ICS is further diminished. This polymorphism is present in ~20% of US Blacks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1070 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Blacks and Exacerbations on LABA vs. Tiotropium (BELT)|
|Study Start Date :||March 30, 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Tiotropium bromide will be evaluated as a treatment for asthma.
Tiotropium bromide 18 mcg once daily for one year of treatment.
Other Name: Spiriva
Active Comparator: Salmeterol or Formoterol
Long acting beta agonists (Serevent, Foradil) are the standard treatments for moderate asthma. The efficacy of Tiotropium will be compared to this standard.
Salmeterol 50 mcg twice daily for one year of treatment.
Other Name: SereventDrug: Formoterol
Formoterol 12 mcg twice daily for one year
Other Name: Foradil
- Time to Asthma Exacerbation (Mean Number of Exacerbations/Person-year) [ Time Frame: evaluated monthly (on average) via questionnaire for 12 months ]We summarize the survival experience using mean number of exacerbations/person-year and compare it using the log-rank test comparing kaplan-meier survival curve.
- Change in FEV1 [ Time Frame: from baseline to 12 months ]Average change in lung function (FEV1) evaluated by spirometry per participant over 12 months
- Change in Asthma Control Questionnaire (ACQ) [ Time Frame: from baseline to 12 months ]
Average Change in Asthma Control Score Per Participant Over 12 Months Using the Asthma Control Questionnaire (ACQ).
The ACQ has six questions regarding symptoms, rescue short-acting β-agonist use and one about FEV1 % predicted. A 7-point scale (0 = no impairment, 6 = maximum impairment) is used for each question and the ACQ score is the mean value of these questions - hence between 0 (totally controlled) and 6 (severely uncontrolled).
- Change in Asthma Quality of Life (AQLQ) [ Time Frame: from baseline to 12 months ]
Average Change in Asthma Quality of Life Score Per Participant Over 12 Months Using the Asthma Quality of Life Questionnaire (AQLQ).
The AQLQ has 32 questions in four domains (symptoms, activity limitation, emotional function, and environmental stimuli) and measures the functional problems that are troublesome to individuals with asthma. Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items); 7-point Likert scale (7 = not impaired at all - 1 = severely impaired); scores range 1-7, with higher scores indicating better quality of life.
- Change in Asthma Symptom Utility Index (ASUI) [ Time Frame: from baseline to 12 months ]
Average Change in Asthma Symptom Utility Score Per Participant Over 12 Months Using the Asthma Symptom Utility Index (ASUI).
The ASUI is an 11-item preference-based outcome measure used in clinical trials and cost-effectiveness studies for asthma and is designed to assess the frequency and severity of cough, wheeze, dyspnea, nighttime awakenings, and side effects, weighted according to patient preferences.
4-point Likert scale to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe); scores range from 0 (worst possible symptoms) to 1 (no symptoms).
- Change in Symptom-Free Day Questionnaire (SFDQ) [ Time Frame: from baseline to 12 months ]
Average Change in Symptom-Free Days Per Participant Over 12 Months Using the Symptom-Free Day Questionnaire (SFDQ).
The asthma symptom free day questionnaire (SFDQ) quantifies the number of days with neither daytime nor nighttime asthma symptoms, nor awakenings due to asthma symptoms.
- Change in Rescue Medication Use [ Time Frame: from baseline to 12 months ]Average Change in Rescue Medication Use Per Participant Over 12 Months. Monthly questionnaires will evaluate the amount of rescue medication subjects have used on average, measured in puffs per day.
- Change in Moderate Asthma Deterioration [ Time Frame: from baseline to 12 months ]Average Change in Moderate Asthma Deterioration Per Participant Over 12 Months. The definition of a moderate asthma deterioration should include one or more of the following: deterioration in symptoms, deterioration in lung function, or increased rescue bronchodilator use. These features should last for 2 days or more, but not be severe enough to warrant systemic corticosteroid use and/or hospitalization.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290874
|United States, Florida|
|Edward Waters College Medical Center (Mayo)|
|Jacksonville, Florida, United States, 32209|
|United States, Georgia|
|Urban Family Practice|
|Marietta, Georgia, United States, 30067|
|Albany Area Primary Healthcare, Inc|
|Newton, Georgia, United States, 39870|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48201|
|United States, Mississippi|
|G.A. Carmichael F.H.C.|
|Canton, Mississippi, United States, 39046|
|United States, Missouri|
|Swope Parkway Health Center|
|Kansas City, Missouri, United States, 64130|
|United States, New York|
|Montefiore Medical Group|
|Bronx, New York, United States, 10462|
|UNYNET - Jefferson Family Medicine|
|Buffalo, New York, United States, 14215|
|United States, North Carolina|
|Carolinas Medical Center - NorthEast (Lovelace)|
|Kannapolis, North Carolina, United States, 28081|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Family Medicine Occupational Health Center|
|Shaker Heights, Ohio, United States, 44120|
|United States, South Carolina|
|BJHCHS - Hardeeville Medical Center|
|Ridgeland, South Carolina, United States, 29936|
|Principal Investigator:||Elliot Israel, MD||Brigham and Women's Hospital|