ROBUST- Reduction Of exacerbations in Bronchiectasis USing Tiotropium

Not Applicable

Completed

• Conditions: on-cystic Bronchiectasis; Non-cystic Bronchiectasis; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12612000206820
• Lead Sponsor: Health Research Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-based exacerbation frequency- ascertained using data from the daily diary card kept by participants and clinical assessment during follow up visits.[week 0-26 ; week 30 to 54]