Protocols Currently Recruiting
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Long-acting Beta Agonist Step-Down Study (LASST)
Co-funded by GlaxoSmithKline
Current asthma guidelines recommend stepping down therapy once asthma is controlled for at least three months. For patients treated with inhaled corticosteroids (ICS) alone, a dose reduction of 25–50 percent to a minimal dose that controls disease is established. However, the optimal approach to reducing treatment in patients with asthma that is well controlled on fixed dose combination ICS/LABA (long-acting beta agonists) is not clear. The study will compare three approaches of care to patients with asthma well controlled for three months on combination ICS/LABA therapy: reduction of ICS dose and maintenance of LABA, initial discontinuation of LABA with continuation of ICS and continuation of stable dose ICS/LABA. The data will allow the determination of the optimal treatment strategy defined as that which results in the lowest rate of treatment failure over 48 weeks of follow up. Additional exploratory analyses will include assessing risk factors for step-down failure and assessing the optimal duration of time that asthma control should be maintained before therapy is reduced.
Effect of Positive Airway Pressure on Reducing Airway Reactivity in Patients with Asthma (CPAP)
Co-Funded by the National Institutes of Health’s National Heart, Lung and Blood Institute
The development of alternative methods to drug use in improving asthma control is necessary. This study will test whether the use of CPAP, a current treatment for sleep apnea, will improve asthma control. CPAP is a way of rhythmically increasing airway pressure by applying external pressure through the nose or mouth to prevent large airway collapse during sleep. The researchers propose that applying the same rhythmically pressure to the smaller airways will lessen the airway constriction that occurs during an asthma attack. The results of this study may lead to prescribing CPAP to patients with difficulties in achieving asthma control. This proof-of-principle clinical trial will randomize 192 participants, with stable documented asthma and who do not have sleep disorders, into one of three treatment groups for 12 weeks. Treatment arms include: nocturnal CPAP 10 cm H2O, nocturnal CPAP 5 cm H2O and nocturnal sham CPAP (2O).
Smoking Asthmatics Pilot Study (SAPS)
Co-Funded by the National Institutes of Health’s National Heart, Lung and Blood Institute
It has been estimated that 20 to 30% of persons with asthma smoke and there is evidence that smokers are relatively resistant to standard treatments compared to non-smoking asthmatics. Paradoxically, asthmatics who smoke are routinely excluded from studies of treatments for asthma. Treatment of asthmatics who are currently smoking is, therefore, an important but understudied area. The goal of this study is to (1) assess the ability of the 19 ACRC Network clinical sites to identify and enroll an adequate number of smoking asthmatics and (2) evaluate the performance of standard measures of asthma control in treatment outcomes among asthmatics who smoke in preparation for a future full scale trial. The proposed full-scale, randomized, clinical trial will evaluate the comparative effectiveness of three competing approaches to add-on therapy in smoking asthmatics with mild to moderate persistent asthma that are not adequately controlled by the currently recommended asthma treatments.
To participate in any of these trials contact your nearest ACRC Center.

