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

• Time to treatment failure [Time Frame: Measured at Week 36 of the treatment period]

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 will begin with a 4-week period during which participants will be monitored while they use an inhaler containing a low dose of inhaled corticosteroid medication. Participants will then be 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 will undergo 2 to 4 weeks of adherence testing, which will involve using three inhalers that have electronic monitoring devices attached to them. Participants will also be asked to measure and record their breathing rates and lung function in a study diary.

BASALT participants will then be randomly assigned to one of three treatment groups: SBA, BBA, or GBA. Each participant will be given four inhalers: one inhaler will contain albuterol, which will be used on an as-needed-basis as rescue medication; one inhaler will contain corticosteroid medication; and two inhalers will contain placebo. One of the latter three inhalers will be used each time the albuterol inhaler is used, and the other two inhalers will be used on a daily basis. Study visits will occur at Weeks 2, 4, 6, 12, 18, 24, 30, and 36 of the treatment period. Inhalers will be adjusted during these visits based on SBA, BBA, or GBA guidelines. At selected visits, the following will 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 will record asthma symptoms and medication usage in a daily diary.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both 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:

Beta-agonist reversibility to 4 puffs albuterol of at least 12% OR
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:

Received prescription for or used asthma controller within the 12 months prior to study entry OR
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 two weeks of the adherence testing period
75% compliance with recording peak flow measurements and symptoms in a symptom diary during the last two 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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00495157 Vernon M. Chinchilli, PhD 717-531-4262 vchinchi@psu.edu

United States, California

University of California, San Francisco, San Francisco, California, 94143, United States; Recruiting Homer A. Boushey, MD 415-476-8019 homer.boushey@ucsf.edu Stephen Lazarus, MD 415-476-2091 lazma@ucsf.edu Homer A. Boushey, MD, Principal Investigator

University of California, San Diego, San Diego, California, 92093, United States; Recruiting Stephen I. Wasserman, MD 858-822-4261 swasserman@ucsd.edu Joe Ramsdell, MD 619-543-7241 jramsdell@ucsd.edu Stephen I. Wasserman, MD, Principal Investigator

United States, Colorado

National Jewish Medical and Research Center, Denver, Colorado, 80206, United States; Recruiting Richard J. Martin, MD 303-398-1545 martinr@njc.org Stanley J. Szefler, MD, PhD 303-270-2189 szeflers@njc.org Richard J. Martin, MD, Principal Investigator

United States, Massachusetts

Brigham & Women's Hospital, Boston, Massachusetts, 02115, United States; Recruiting Elliot Israel, MD 617-732-8110 eisrael@partners.org Michael Wechsler, MD 617-732-7731 mwechsler@rics.bwh.harvard.edu Elliot Israel, MD, Principal Investigator

United States, Missouri

Washington University, St. Louis, St. Louis, Missouri, 63130, United States; Recruiting Mario Castro, MD 314-362-6904 castrom@im.wustl.edu Michael J. Walter, MD 314-362-8987 mwalter@im.wustl.edu Mario Castro, MD, Principal Investigator

United States, New York

Columbia University Medical Center, New York, New York, 10032, United States; Recruiting Emily A. DiMango, MD 212-305-0290 ead3@columbia.edu Emily A. DiMango, MD, Principal Investigator

United States, North Carolina

Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States; Recruiting Stephen P. Peters, MD, PhD 336-713-7500 sppeters@wfubmc.edu Eugene Bleecker, MD 336-713-7500 ebleeck@wfubmc.edu Stephen P. Peters, MD, PhD, Principal Investigator

Duke University Medical Center, Durham, North Carolina, 27710, United States; Recruiting Monica Kraft, MD 919-479-0719 monica.kraft@duke.edu Monica Kraft, MD, Principal Investigator

United States, Texas

University of Texas Medical Branch, Galveston, Texas, 77555, United States; Recruiting William J. Calhoun, MD 409-772-2436 wjcalhou@utmb.edu Bill T. Ameredes, PhD 409-772-8104 btamered@utmb.edu William J. Calhoun, MD, Principal Investigator

United States, Wisconsin

University of Wisconsin, Madison, Madison, Wisconsin, 53706, United States; Recruiting Robert F. Lemanske, MD 608-263-6184 rfl@medicine.wisc.edu Christine A. Sorkness, PharmD 608-262-8237 sorkness@facstaff.wisc.edu Robert F. Lemanske, MD, Principal Investigator

Study chairs or principal investigators

William J. Calhoun, MD, Principal Investigator, University of Texas, Galveston Mario Castro, MD, Principal Investigator, Washington University, St. Louis Robert F. Lemanske, MD, Principal Investigator, University of Wisconsin, Madison Richard J. Martin, MD, Principal Investigator, National Jewish Medical and Research Center Elliot Israel, MD, Principal Investigator, Brigham and Women's Hospital Stephen P. Peters, MD, PhD, Principal Investigator, Wake Forest University Homer A. Boushey, MD, Principal Investigator, University of California, San Francsico Stephen I. Wasserman, MD, Principal Investigator, University of California, San Diego Emily DiMango, MD, Principal Investigator, Columbia University Medical Center Monica Kraft, MD, Principal Investigator, Duke University Reuben M. Cherniack, MD, Study Chair, National Jewish Medical and Research Center