Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
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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 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) |
- Time to Treatment Failure (Measured in Days) [ Time Frame: Measured during the 36-week treatment period ] [ Designated as safety issue: No ]
- 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 ]
| 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: 1
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)
Other Name: QVAR®
|
|
Experimental: 2
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)
Other Name: QVAR®
|
|
Experimental: 3
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)
Other Name: QVAR®
|
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 |
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 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| 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 | |
| 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 |
| Principal Investigator: | Monica Kraft, MD | Duke University |
| Study Chair: | Reuben M. Cherniack, MD | National Jewish Health |
More Information
Additional Information:
No publications provided by National Heart, Lung, and Blood Institute (NHLBI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00495157 History of Changes |
| Other 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 |
| Results First Received: | April 30, 2012 |
| Last Updated: | April 30, 2012 |
| 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 February 13, 2013
