Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics

• Status: Completed
• Trial end date: 2019-05-22
• Target enrollment: 0
• Participant gender: All

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 Withdrawn subjects may be replaced.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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Treatments: Bromides; Bronchodilator Agents; Olodaterol; Tiotropium Bromide

Criteria

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