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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00495157
First received: June 28, 2007
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Behavioral: Symptom-based adjustment
Behavioral: Biomarker-based adjustment
Behavioral: Guideline-based adjustment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Time to Treatment Failure (Measured in Days) [ Time Frame: Measured during the 36-week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Episodes of Treatment Failure [ Time Frame: Measured during the 36-week treatment period ] [ Designated as safety issue: No ]
  • Time to First Asthma Exacerbation [ Time Frame: Measured during the 36-week treatment period ] [ Designated as safety issue: No ]
  • Number of Asthma Exacerbations [ Time Frame: Measured during the 36-week treatment period ] [ Designated as safety issue: No ]
  • Tests of Airway Caliber and Responsiveness (Forced Expiratory Volume in One Second (FEV1) Pre- and Post-bronchodilator Inhalation), Methacholine Provocative Concentration at 20% (PC20) [ Time Frame: Measured during the 36-week treatment period ] [ Designated as safety issue: No ]
  • Tests of Airway Inflammation (Exhaled Breath Condensate (EBC), Fractional Exhaled Nitric Oxide (FeNO), Sputum Eosinophils) [ Time Frame: Measured during the 36-week treatment period ] [ Designated as safety issue: No ]
  • Quality-of-life (AQLQ), Asthma Control Questionnaire (ACQ), and Number of Visit Days That ACQ is Less Than 1.25 [ Time Frame: Measured during the 36-week treatment period ] [ Designated as safety issue: No ]
  • Total Amount of Oral Prednisone Required and Total Amount of Inhaled Steroids [ Time Frame: Measured during the 36-week treatment period ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Measured during the 36-week treatment period ] [ Designated as safety issue: Yes ]

Enrollment: 342
Study Start Date: June 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Symptom-based adjustment
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Behavioral: Symptom-based adjustment
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Experimental: Biomarker-based adjustment
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Behavioral: Biomarker-based adjustment
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Experimental: Guideline-based adjustment
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Behavioral: Guideline-based adjustment
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for BASALT and TALC Studies:

  • Clinical history consistent with asthma
  • Forced expiratory volume in one second (FEV1) greater than 40% of predicted value
  • Asthma confirmed by one of the following two criteria:

    1. Beta-agonist reversibility to 4 puffs albuterol of at least 12% OR
    2. Methacholine provocative concentration at 20% (PC20) FEV1 of 8 milligrams per millimeter (mg/mL) or less when not on an inhaled corticosteroid, or 16 mg/mL or less when on an inhaled corticosteroid
  • Need for daily controller therapy (i.e., inhaled corticosteroids, leukotriene modifiers, and/or long-acting beta-agonists) based on one or more of the following criteria:

    1. Received prescription for or used asthma controller within the 12 months prior to study entry OR
    2. Experienced symptoms for more than twice a week and not on asthma controller
  • If on inhaled steroids (any drug at any dose not exceeding the equivalent of 1000 micrograms (mcg) of fluticasone daily), participant must have been on a stable dose for at least 2 weeks prior to study entry
  • Non-smoker (i.e., total lifetime smoking history less than 10 pack-years; no smoking for at least 1 year prior to study entry)
  • Willing to use an effective form of birth control throughout the study

Inclusion Criteria for BASALT Study:

  • Ability to measure peak expiratory flow (PEF) each morning using the electronic peak flow meter (EPFM) device and to accurately transcribe the PEF measurements onto the diary cards at least 75% of the time during the last 2 weeks of the adherence testing period
  • 75% compliance with recording peak flow measurements and symptoms in a symptom diary during the last 2 weeks of the adherence testing period
  • Ability to take Inhalers A, B, and C at least 75% of scheduled doses; 75% compliance per inhaler is required
  • No treatment failure (includes significant asthma exacerbation) within the last 4 weeks

Exclusion Criteria for BASALT and TALC Studies:

  • Lung disease other than asthma, including chronic obstructive pulmonary disease (COPD) and chronic bronchitis
  • Established or suspected diagnosis of vocal cord dysfunction
  • Significant medical illness other than asthma
  • History of respiratory tract infection within the 4 weeks prior to study entry
  • History of a significant exacerbation of asthma within the 4 weeks prior to study entry
  • History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the 5 years prior to study entry
  • Hyposensitization therapy other than an established maintenance regimen
  • Inability to coordinate use of the delivery devices used in the study, based on the opinion of the investigator or clinical coordinator
  • Pregnant

Exclusion Criteria for BASALT Study:

  • Inability to coordinate use of the medication delivery devices used in the study, based on the opinion of the investigator or clinical coordinator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495157

Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92093
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University, St. Louis
St. Louis, Missouri, United States, 63130
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
United States, Wisconsin
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: William J. Calhoun, MD University of Texas, Galveston
Principal Investigator: Mario Castro, MD Washington University School of Medicine
Principal Investigator: Robert F. Lemanske, MD University of Wisconsin, Madison
Principal Investigator: Richard J. Martin, MD National Jewish Health
Principal Investigator: Elliot Israel, MD Brigham and Women's Hospital
Principal Investigator: Stephen P. Peters, MD, PhD Wake Forest School of Medicine
Principal Investigator: Homer A. Boushey, MD University of California, San Francsico
Principal Investigator: Stephen I. Wasserman, MD University of California, San Diego
Principal Investigator: Emily DiMango, MD Columbia University
Principal Investigator: Monica Kraft, MD Duke University
Study Chair: Reuben M. Cherniack, MD National Jewish Health
  More Information

Additional Information:
No publications provided by Milton S. Hershey Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vernon M. Chinchilli, PhD, Professor and Chair, Department of Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00495157     History of Changes
Other Study ID Numbers: 494, 5U10HL074231, U10 HL074206, U10 HL074208, U10 HL074073, U10 HL074227, U10 HL074225, U10 HL074204, U10 HL074218, U10 HL074212, U10 HL074231
Study First Received: June 28, 2007
Results First Received: April 30, 2012
Last Updated: April 5, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 20, 2014