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

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00495157

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	Drug: Beclomethasone dipropionate	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Beclomethasone dipropionate Beclomethasone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Time to treatment failure [ 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 (FEV1 pre- and post-bronchodilator inhalation), methacholine 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 ]

Estimated Enrollment:	320
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Symptom-based adjustment of beclomethasone dipropionate HFA (QVAR® 40 mcg or QVAR® 80 mcg)	Drug: Beclomethasone dipropionate Beclomethasone dipropionate HFA (QVAR® 40 mcg or QVAR® 80 mcg)
2: Experimental Biomarker-based adjustment of beclomethasone dipropionate HFA (QVAR® 40 mcg or QVAR® 80 mcg)	Drug: Beclomethasone dipropionate Beclomethasone dipropionate HFA (QVAR® 40 mcg or QVAR® 80 mcg)
3: Experimental Guideline-based adjustment of beclomethasone dipropionate HFA (QVAR® 40 mcg or QVAR® 80 mcg)	Drug: Beclomethasone dipropionate Beclomethasone dipropionate HFA (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
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. PC20 FEV1 methacholine of 8 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 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

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

Contacts

Contact: Vernon M. Chinchilli, PhD

717-531-4262

vchinchi@psu.edu

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143
Contact: Homer A. Boushey, MD 415-476-8019 homer.boushey@ucsf.edu
Contact: Stephen Lazarus, MD 415-476-2091 lazma@ucsf.edu
Principal Investigator: Homer A. Boushey, MD
Sub-Investigator: Stephen Lazarus, MD
University of California, San Diego	Recruiting
San Diego, California, United States, 92093
Contact: Stephen I. Wasserman, MD 858-822-4261 swasserman@ucsd.edu
Contact: Joe Ramsdell, MD 619-543-7241 jramsdell@ucsd.edu
Principal Investigator: Stephen I. Wasserman, MD
Sub-Investigator: Joe Ramsdell, MD
United States, Colorado
National Jewish Medical and Research Center	Recruiting
Denver, Colorado, United States, 80206
Contact: Richard J. Martin, MD 303-398-1545 martinr@njc.org
Contact: Stanley J. Szefler, MD, PhD 303-270-2189 szeflers@njc.org
Principal Investigator: Richard J. Martin, MD
Sub-Investigator: Stanley J. Szefler, MD, PhD
United States, Massachusetts
Brigham & Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elliot Israel, MD 617-732-8110 eisrael@partners.org
Contact: Michael Wechsler, MD 617-732-7731 mwechsler@rics.bwh.harvard.edu
Principal Investigator: Elliot Israel, MD
Sub-Investigator: Michael Wechsler, MD
United States, Missouri
Washington University, St. Louis	Recruiting
St. Louis, Missouri, United States, 63130
Contact: Mario Castro, MD 314-362-6904 castrom@im.wustl.edu
Contact: Michael J. Walter, MD 314-362-8987 mwalter@im.wustl.edu
Principal Investigator: Mario Castro, MD
Sub-Investigator: Michael J. Walter, MD
United States, New York
Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Contact: Emily A. DiMango, MD 212-305-0290 ead3@columbia.edu
Principal Investigator: Emily A. DiMango, MD
United States, North Carolina
Wake Forest University Health Sciences	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Stephen P. Peters, MD, PhD 336-713-7500 sppeters@wfubmc.edu
Contact: Eugene Bleecker, MD 336-713-7500 ebleeck@wfubmc.edu
Principal Investigator: Stephen P. Peters, MD, PhD
Sub-Investigator: Eugene Bleecker, MD
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Monica Kraft, MD 919-479-0719 monica.kraft@duke.edu
Principal Investigator: Monica Kraft, MD
United States, Texas
University of Texas Medical Branch	Recruiting
Galveston, Texas, United States, 77555
Contact: William J. Calhoun, MD 409-772-2436 wjcalhou@utmb.edu
Contact: Bill T. Ameredes, PhD 409-772-8104 btamered@utmb.edu
Principal Investigator: William J. Calhoun, MD
Sub-Investigator: Bill T. Ameredes, PhD
United States, Wisconsin
University of Wisconsin, Madison	Recruiting
Madison, Wisconsin, United States, 53706
Contact: Robert F. Lemanske, MD 608-263-6184 rfl@medicine.wisc.edu
Contact: Christine A. Sorkness, PharmD 608-262-8237 sorkness@facstaff.wisc.edu
Principal Investigator: Robert F. Lemanske, MD
Sub-Investigator: Christine A. Sorkness, PharmD

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	William J. Calhoun, MD	University of Texas, Galveston
Principal Investigator:	Mario Castro, MD	Washington University, St. Louis
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 University
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 Medical Center
Principal Investigator:	Monica Kraft, MD	Duke University
Study Chair:	Reuben M. Cherniack, MD	National Jewish Health

More Information

Click here for the Asthma Clinical Research Network Web site This link exits the ClinicalTrials.gov site

Responsible Party:	Pennsylvania State University, College of Medicine ( Vernon M. Chinchilli, PhD )
Study ID Numbers:	494, U10 HL074206, U10 HL074208, U10 HL074073, U10 HL074227, U10 HL074225, U10 HL074204, U10 HL074218, U10 HL074212, U10 HL074231
Study First Received:	June 28, 2007
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00495157
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Beclomethasone
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009