The Effects of One Month of Therapy with the Long-acting Bronchodilator Tiotropium on Small Airway Physiology in Chronic Obstructive Pulmonary Disease

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12615000076572
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Adults with physician-diagnosed mild-moderate chronic obstructive pulmonary disease, with history of current or past smoking (total exposure > 10 pack years)

Exclusion Criteria

* Use of tiotropium or any other LAMA or LABA within the previous 4 weeks
* Musculoskeletal (for example, severe arthritis) or other conditions which limit the ability to walk at near-maximal pace
* Significant cardiac disease (ischaemic heart disease or arrhythmia) deemed by the investigators or the subject’s treating cardiologist to make it unsafe for the subject to undertake a supervised near-maximal exercise test
* Documented hypersensitivity to, or intolerance of, anti-cholinergic therapies
* Significant respiratory infection or documented exacerbation of COPD within the previous 6 weeks
* Other active or chronic respiratory pathologies (for example, interstitial lung disease, asthma, chest wall pathology causing ventilatory restriction)
* Past history of lung surgery (including lobectomy or pneumonectomy, but not lung biopsy) or thoracic radiation therapy (excluding isolated mediastinal radiation therapy with no evidence of subsequent pulmonary fibrosis)
* Any major comorbidities deemed to impact on respiratory physiology or symptoms, including severe on uncontrolled heart failure, morbid obesity, muscular or neurological disorders causing respiratory muscle weakness or dysfunctional swallowing
* History of chronic kidney disease (moderate to severe, eGFR less than or equal to 45 mL/min/1.73m2) or severe hepatic impairment
* Unable to perform lung function testing at the enrollment visit
* Dependence on domiciliary supplemental oxygen, unable to go without for at least 1 hour
* Women who are breast feeding, pregnant, or unwilling to avoid pregnancy during the study period
* Unable to provide informed consent
* Current enrolment in other trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified