None listed
Conditions
Brief summary
The study aims to assess the effect of tiotropium compared with placebo in adult patients with non-cystic bronchiectasis with airflow obstruction. The primary aim is to assess whether tiotropium reduces event-based exacerbation frequency. And the secondary aims are whether tiotropium increases time to first exacerbation, improves lung function, reduces symptom-based exacerbation, improves quality of life, reduces airway inflammation, reduces bacterial infection and improves exercise capacity and forced vital capacity.
Interventions
Inhaled Tiotropium or placebo 18 microgram daily for 6 months with a washout period of 4 weeks then crossover to the opposite arm of treatment for another 6 months.
Sponsors
Health Research Council
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
- adult patients - able to provide written informed consent - confirmed diagnosis of bronchiectasis by high resolution CT scan - FEV1/FVC ratio < 70% - History of at least one pulmonary exacerbation requiring antibiotic treatment in the past 12 months
Exclusion criteria
Smoking history of > 20 pack years Primary diagnosis of asthma defined as 1 or more admissions to hospital in the past year with a primary discharge diagnosis of asthma or a history of more courses of oral steroids than antibiotics in the past year Continuous antibiotic therapy Known adverse reaction to tiotropium Cystic fibrosis Hypogammaglobulinaemia Allergic BronchoPulmonary Aspergillosis History of non-tuberculous mycobacterial infection (treated or untreated) Bronchiectasis exacerbation or respiratory infection requiring oral or intravenous antibiotic within 6 weeks before randomisation Use of oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses more than or equal to 10 mg/day Unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year Any other serious co-existing illness that precludes patients from the study Narrow-angle glaucoma Symptomatic prostatic hyperplasia or bladder-neck obstruction (patients whose symptoms are controlled on treatment may be included) Inability to complete HRQL questionnaires Female patients who are pregnant or breast feeding Known non-compliance with medications and follow ups Patients taking tiotropium (can be included if they are willing to withhold tiotropium for two weeks prior to randomisation and throughout the whole duration of the study) Patients who are unable or unwilling to stop ipratropium (Atrovent inhaler). A salbutamol inhaler may be substituted for the ipratropium inhaler
Outcome results
None listed