Asthma Clinical Research Network Trial (ACRN) - Best Adjustment Strategy for Asthma in Long Term (BASALT) and Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC)
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June 2007 - July 2010 (BASALT) | May 2008 - May 2010 (TALC)
December 1, 2012
December 1, 2012
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Additional Study Information
The BASALT and TALC studies shared a common 4 week run-in period and at run-in visit 3, each eligible participant was allocated to either the BASALT or TALC study. Due to the common run-in period, these studies have been combined.
To determine if adjustment of inhaled corticosteroid therapy based on exhaled nitric oxide or day-to-day symptoms is superior to guideline-informed, physician assessment–based adjustment in preventing treatment failure in adults with mild to moderate asthma.
This study examined the effectiveness of the medication tiotropium bromide combined with a low dose of inhaled corticosteroid (ICS) at maintaining asthma control in people with moderately severe asthma.
No consensus exists for adjusting inhaled corticosteroid therapy in patients with asthma. Approaches include adjustment at outpatient visits guided by physician assessment of asthma control (symptoms, rescue therapy, pulmonary function), based on exhaled nitric oxide, or on a day-to-day basis guided by symptoms.
Long-acting beta-agonist (LABA) therapy improves symptoms in patients whose asthma is poorly controlled by an inhaled glucocorticoid alone. Alternative treatments for adults with uncontrolled asthma are needed.
342 adults with mild to moderate asthma controlled by low-dose inhaled corticosteroid therapy.
210 patients with asthma inadequately controlled by a low dose of an inhaled glucocorticoid.
BASALT was a randomized, parallel, 3-group, placebo-controlled, multiple-blinded trial of adults with mild to moderate asthma controlled by low-dose inhaled corticosteroid therapy (n = 114 assigned to physician assessment–based adjustment [101 completed], n = 115 to biomarker-based [exhaled nitric oxide] adjustment [92 completed], and n = 113 to symptom-based adjustment [97 completed]). For physician assessment–based adjustment and biomarker-based (exhaled nitric oxide) adjustment, the dose of inhaled corticosteroids was adjusted every 6 weeks; for symptom-based adjustment, inhaled corticosteroids were taken with each albuterol rescue use.
In a three-way, double-blind, triple-dummy crossover trial involving adult patients with asthma, the study evaluated the addition of tiotropium bromide (a long-acting anticholinergic agent approved for the treatment of chronic obstructive pulmonary disease but not asthma) to an inhaled glucocorticoid, as compared with a doubling of the dose of the inhaled glucocorticoid (primary superiority comparison) or the addition of the LABA salmeterol (secondary noninferiority comparison).
Among adults with mild to moderate persistent asthma controlled with low-dose inhaled corticosteroid therapy, the use of either biomarker-based or symptom-based adjustment of inhaled corticosteroids was not statistically superior to physician assessment–based adjustment of inhaled corticosteroids in time to treatment failure.
When added to an inhaled glucocorticoid, tiotropium improved symptoms and lung function in patients with inadequately controlled asthma. Its effects appeared to be equivalent to those with the addition of salmeterol.
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 1.5 MB)
- BASALT Forms (PDF - 1.7 MB)
- BASALT Protocol (PDF - 862.7 KB)
- Mannitol Protocol (PDF - 468.0 KB)
- Runin Forms (PDF - 958.6 KB)
- TALC Forms (PDF - 4.8 MB)
- TALC Protocol (PDF - 1.3 MB)
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