ROBUST- Reduction Of exacerbations in Bronchiectasis USing Tiotropium

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2012
INTERVENTION: 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. CONDITION: Non‐cystic Bronchiectasis PRIMARY OUTCOME: Event‐based exacerbation frequency‐ ascertained using data from the daily diary card kept by participants and clinical assessment during follow up visits. SECONDARY OUTCOME: Adverse events such as dry mouth, dry skin, blurred vision and difficulty in passing urine will be assessed at every follow up clinic visits. Airway function measured by FEV1 changes Change in Exercise capacity measured by 6 minutes walk test Change in Forced vital capacity (FVC) ‐ measured by performing forced spirometry at protocol required follow up visits. Change in markers of airway inflammation ‐ by comparing sputum analysis results on sputum samples collected at baseline and end of treatment for each treatment period. Cost and cost effectiveness of tiotropium treatment ‐ cost analysis from participants daily diary card recording visits to General Practitioners or other Health providers. Health‐related quality of life measured by changes in health questionnaires Symptom‐based exacerbation frequency ‐ ascertained using data from the daily diary card kept by participants and clinical assessment during follow up visits. Time to first exacerbation ‐ ascertained using data from the daily diary card kept by participants and clinical assessment during follow up visits. 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
Epistemonikos ID: 58474d203a1faf4160cc7a4780874ae4586db047
First added on: Aug 22, 2024