Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics
Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics
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 Withdrawn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.
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