Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
NCT ID: NCT00495157
Last Updated: 2013-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
342 participants
INTERVENTIONAL
2007-06-30
2010-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Symptom-based adjustment
Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
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 of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Biomarker-based adjustment
Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Guideline-based adjustment
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Guideline-based adjustment
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Interventions
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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 of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Guideline-based adjustment
Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* Inability to coordinate use of the medication delivery devices used in the study, based on the opinion of the investigator or clinical coordinator
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Milton S. Hershey Medical Center
OTHER
Responsible Party
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Vernon M. Chinchilli, PhD
Professor and Chair, Department of Public Health Sciences
Principal Investigators
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William J. Calhoun, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas, Galveston
Mario Castro, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Robert F. Lemanske, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Richard J. Martin, MD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health
Elliot Israel, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Stephen P. Peters, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Homer A. Boushey, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francsico
Stephen I. Wasserman, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Emily DiMango, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Monica Kraft, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Reuben M. Cherniack, MD
Role: STUDY_CHAIR
National Jewish Health
Locations
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University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Washington University, St. Louis
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Wisconsin, Madison
Madison, Wisconsin, United States
Countries
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References
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Lugogo N, Green CL, Agada N, Zhang S, Meghdadpour S, Zhou R, Yang S, Anstrom KJ, Israel E, Martin R, Lemanske RF Jr, Boushey H, Lazarus SC, Wasserman SI, Castro M, Calhoun W, Peters SP, DiMango E, Chinchilli V, Kunselman S, King TS, Icitovic N, Kraft M. Obesity's effect on asthma extends to diagnostic criteria. J Allergy Clin Immunol. 2018 Mar;141(3):1096-1104. doi: 10.1016/j.jaci.2017.04.047. Epub 2017 Jun 15.
Calhoun WJ, Ameredes BT, King TS, Icitovic N, Bleecker ER, Castro M, Cherniack RM, Chinchilli VM, Craig T, Denlinger L, DiMango EA, Engle LL, Fahy JV, Grant JA, Israel E, Jarjour N, Kazani SD, Kraft M, Kunselman SJ, Lazarus SC, Lemanske RF, Lugogo N, Martin RJ, Meyers DA, Moore WC, Pascual R, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Wasserman SI, Walter MJ, Wechsler ME, Boushey HA; Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute. Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: the BASALT randomized controlled trial. JAMA. 2012 Sep 12;308(10):987-97. doi: 10.1001/2012.jama.10893.
Sutherland ER, Goleva E, Jackson LP, Stevens AD, Leung DY. Vitamin D levels, lung function, and steroid response in adult asthma. Am J Respir Crit Care Med. 2010 Apr 1;181(7):699-704. doi: 10.1164/rccm.200911-1710OC. Epub 2010 Jan 14.
Related Links
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Click here for the Asthma Clinical Research Network Web site
Other Identifiers
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494
Identifier Type: -
Identifier Source: org_study_id
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