Asthma
Conditions
Keywords
tiotropium, olodaterol, smoker, cigarette, bronchodilator
Brief summary
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 Withdrawn subjects may be replaced.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.
Detailed description
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.
Interventions
DRUGolodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg
Inhaler: 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. 2 puffs once daily
DRUGolodaterol 2.5 mcg
Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily
Sponsors
University of Dundee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female volunteers aged 18-65 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms beclomethasone dipropionate equivalent dose daily) * Current smoker * Forced Expiratory Volume in 1 second (FEV1) ≥ 60 % predicted * Ability to give informed consent * Agreement for their General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being
Exclusion criteria
* Other significant respiratory diseases, in the opinion of the investigator, such as COPD or bronchiectasis. * An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement or 3 months if hospital admission was required * Any clinically significant medical condition that may endanger the health or safety of the participant * Participation in another drug trial within 30 days before the commencement of the study * Pregnancy or lactation * Unable to comply with the procedures of the protocol * Unable or unwilling to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airway resistance at 5Hz (R5) | 2-4 weeks | measured by Impulse oscillometry (IOS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RF | 2-4 weeks | Impulse Oscillometry: Resonant Frequency |
| X5 | 2-4 weeks | Impulse Oscillometry: Reactance at 5Hz |
| AX | 2-4 weeks | Impulse Oscillometry: Reactance Area |
| R5-R20 | 2-4 weeks | Impulse Oscillometry: Resistance at 5Hz minus Resistance at 20Hz, equating to small airway resistance |
| R20 | 2-4 weeks | Impulse Oscillometry: Resistance at 20Hz |
| FEF25-75 pre and post challenge | 2-4 weeks | Spirometry: Forced expiratory flow 25%-75% pre and post bronchial challenge (assessing change) |
| FVC pre and post challenge | 2-4 weeks | Spirometry: Forced vital capacity pre and post bronchial challenge (assessing change) |
| FEV1 pre and post challenge | 2-4 weeks | Spirometry: Forced expiratory volume in 1 second pre and post bronchial challenge (assessing change) |
| Mannitol PD30 | 2-4 weeks | Provocation dose of mannitol causing 30% increase in R5 |
| Mannitol RDR | 2-4 weeks | Response-Dose Ratio |
| R5 at PD30 | 2-4 weeks | Airway Resistance at 5 Hertz at PD30 |
| Salbutamol recovery time following mannitol challenge | 2-4 weeks | — |
| Domiciliary PEF | 2-4 weeks | Peak Expiratory Flow |
| ACQ | 2-4 weeks | Asthma Control Questionnaire |
Countries
United Kingdom
Outcome results
None listed