Asthma Clinical Trial
Official title:
Proof of Concept Study to Evaluate Single and Chronic Dosing Effects of Ultra-long Acting Bronchodilator Therapy on Mannitol Challenge in Asthmatic Patients Taking Inhaled Corticosteroids
Asthma is a common condition which produces a significant workload for general practice,
hospital outpatient clinics and inpatient admissions. Asthma is caused by inflammation of the
airways which irritates the muscles around the airways causing them to constrict. The
mainstay of asthma treatment is inhaled steroids. If the patients' symptoms are still not
adequately controlled, then a long-acting beta agonist (LABA) inhaler which relaxes the
muscles in the airways and opens it up is frequently added to the inhaled steroids. Despite
this, a substantial proportion of asthmatic patients still do not achieve adequate control of
their symptoms. Recent studies have shown when an alternative inhaler called a long-acting
muscarinic antagonist (LAMA) is added to a LABA - it reduced the number of asthma
exacerbations (flare-ups) and improved airway narrowing.
The mannitol challenge is a test of airway 'twitchiness', an important feature of asthma.
There have been no previous studies assessing the combined effects LABA and LAMA inhalers on
mannitol challenge. The mannitol challenge is particularly relevant as it mimics stimuli
encountered in real life which provoke an asthma attack.
The investigators propose to directly compare indacaterol, a new once-daily LABA with
indacaterol plus tiotropium, a once-daily LAMA, as add-on treatment to inhaled steroids in
persistent asthmatics using the mannitol challenge. The investigators hope that this study
will help us understand how the combination of a LABA and LAMA might help protect against
flare-ups.
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