Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)

Phase 3

Completed

Conditions: Asthma

Interventions: Behavioral: Guideline-based adjustment
Behavioral: Symptom-based adjustment
Behavioral: Biomarker-based adjustment

Registration Number: NCT00495157

Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary: Asthma can be effectively controlled using inhaled corticosteroid medication. Treatment with inhaled corticosteroids often requires periodic adjustments to medication dosing and frequency levels. This study examines whether it is more beneficial to adjust corticosteroid treatment based on asthma symptoms and/or biomarkers of lung function versus standard medical guidelines.

Detailed Description: Asthma is a common, long-term disease that is caused by inflammation of the airways. Symptoms of asthma may include wheezing, coughing, shortness of breath, and chest tightness. The most common treatment for asthma is the use of inhaled corticosteroid medications with periodic adjustments to treatment intensity. For example, corticosteroid dosage is increased when asthma symptoms worsen and decreased when symptoms improve. However, guidelines for making these adjustments, especially reduced intensity adjustments, have not been well established. In people who are initially well controlled on daily low-dose inhaled corticosteroid therapy, symptom-based adjustment (SBA) and/or biomarker-based adjustment (BBA) of inhaled corticosteroid therapy may be more beneficial at maintaining asthma control than standard, guideline-based adjustments (GBA). The purpose of this study is to determine if adjusting treatment based on symptoms and/or lung function biomarkers is more effective at controlling asthma than adjusting corticosteroid use based on standardized medical guidelines.

This study begins with a 4-week period during which participants are monitored while they use an inhaler containing a low dose of inhaled corticosteroid medication. Participants then are assigned to take part in either the BASALT study or the Tiotropium as an Alternative to Long-Acting Beta-Agonists and Corticosteroids (TALC) study, which is a separate Asthma Clinical Research Network (ACRN) study. Participants in BASALT undergo 2 to 4 weeks of adherence testing, which involves using three inhalers that have electronic monitoring devices attached to them. Participants also are asked to measure and record their breathing rates and lung function in a study diary.

BASALT participants are then randomly assigned to one of three treatment groups: SBA, BBA, or GBA. Each participant is given four inhalers: one inhaler contains albuterol, which is used on an as-needed basis as rescue medication; one inhaler contains corticosteroid medication; and two inhalers contain placebo. One of the latter three inhalers is used each time the albuterol inhaler is used, and the other two inhalers are used on a daily basis. Study visits occur at Weeks 2, 4, 6, 12, 18, 24, 30, and 36 of the treatment period. Inhalers are adjusted during these visits based on SBA, BBA, or GBA guidelines. At selected visits, the following procedures occur: physical exam; blood collection; allergy skin testing; heart rate monitoring; lung function and airway testing; methacholine challenge test to determine asthma severity; and questionnaires to assess asthma control, quality of life, and other healthcare factors. Participants record asthma symptoms, peak flow measurements, and medication usage in a daily diary.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 342

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guideline-based adjustment	Guideline-based adjustment	Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Symptom-based adjustment	Symptom-based adjustment	Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Biomarker-based adjustment	Biomarker-based adjustment	Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

Primary Outcome Measures

Name	Time	Method
Time to Treatment Failure (Measured in Days)	Measured during the 36-week treatment period

Secondary Outcome Measures

Name	Time	Method
Number of Episodes of Treatment Failure	Measured during the 36-week treatment period
Time to First Asthma Exacerbation	Measured during the 36-week treatment period
Number of Asthma Exacerbations	Measured during the 36-week treatment period
Tests of Airway Caliber and Responsiveness (Forced Expiratory Volume in One Second (FEV1) Pre- and Post-bronchodilator Inhalation), Methacholine Provocative Concentration at 20% (PC20)	Measured during the 36-week treatment period
Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils)	Measured during the 36-week treatment period
Quality-of-life (AQLQ), Asthma Control Questionnaire (ACQ), and Number of Visit Days That ACQ is Less Than 1.25	Measured during the 36-week treatment period
Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids	Measured during the 36-week treatment period
Adverse Events	Measured during the 36-week treatment period

Trial Locations

Locations (10): Washington University, St. Louis
🇺🇸
St. Louis, Missouri, United States
University of Texas Medical Branch
🇺🇸
Galveston, Texas, United States
National Jewish Medical and Research Center
🇺🇸
Denver, Colorado, United States
University of California, San Diego
🇺🇸
San Diego, California, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
Brigham & Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Duke University Medical Center
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Durham, North Carolina, United States
Wake Forest University Health Sciences
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Winston-Salem, North Carolina, United States
University of Wisconsin, Madison
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Madison, Wisconsin, United States