Single centre, open-label, random order, cross-over trial, recruited over a period of approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn subjects may be replaced. This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function test called impulse oscillometry.
Cigarette smoking in asthma is associated with poorer asthma control and a higher frequency of asthma attacks. Despite this, smoking cessation rates are very low due to the highly addictive nature of tobacco smoking. Asthma in smokers is particularly challenging to manage because it is resistant to the beneficial effects of inhaled corticosteroids, the main treatment for asthma. Unfortunately, there is no guideline consensus regarding how to best manage asthmatics who smoke. Research studies in asthma tend to exclude smokers because of concerns about recruiting patients with chronic obstructive pulmonary disease (COPD). Hence, there is an unmet need for research studies in asthmatics who are unable to stop smoking. In view of the above, we propose to assess the effects of two different types of bronchodilators (inhalers which help open up the airways), in asthmatics who continue to smoke. Participants will receive both of the following drugs for 2-4 weeks in random order, with a 2-3 week washout period in between: Olodaterol which is a new long-acting bronchodilator. Olodaterol combined with tiotropium (dual bronchodilators). We wish to compare these inhalers using a sensitive pulmonary function test called impulse oscillometry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Inhaler: 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. 2 puffs once daily
Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily
Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Airway resistance at 5Hz (R5)
measured by Impulse oscillometry (IOS)
Time frame: 2-4 weeks
RF
Impulse Oscillometry: Resonant Frequency
Time frame: 2-4 weeks
X5
Impulse Oscillometry: Reactance at 5Hz
Time frame: 2-4 weeks
AX
Impulse Oscillometry: Reactance Area
Time frame: 2-4 weeks
R5-R20
Impulse Oscillometry: Resistance at 5Hz minus Resistance at 20Hz, equating to small airway resistance
Time frame: 2-4 weeks
R20
Impulse Oscillometry: Resistance at 20Hz
Time frame: 2-4 weeks
FEF25-75 pre and post challenge
Spirometry: Forced expiratory flow 25%-75% pre and post bronchial challenge (assessing change)
Time frame: 2-4 weeks
FVC pre and post challenge
Spirometry: Forced vital capacity pre and post bronchial challenge (assessing change)
Time frame: 2-4 weeks
FEV1 pre and post challenge
Spirometry: Forced expiratory volume in 1 second pre and post bronchial challenge (assessing change)
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Time frame: 2-4 weeks
Mannitol PD30
Provocation dose of mannitol causing 30% increase in R5
Time frame: 2-4 weeks
Mannitol RDR
Response-Dose Ratio
Time frame: 2-4 weeks
R5 at PD30
Airway Resistance at 5 Hertz at PD30
Time frame: 2-4 weeks
Salbutamol recovery time following mannitol challenge
Time frame: 2-4 weeks
Domiciliary PEF
Peak Expiratory Flow
Time frame: 2-4 weeks
ACQ
Asthma Control Questionnaire
Time frame: 2-4 weeks