The Effects Of Dual, Inhaled Long-Acting Bronchodilators on Complex Lung Mechanics in Chronic Obstructive Pulmonary Disease

Not Applicable

Recruiting

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

• Registration Number: ACTRN12615000336583
• 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: 2015-04-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

* Use of glycopyrronium, indacaterol, salmeterol or any other LAMA or LABA within the previous 4 weeks (unless able to undergo a 2 week washout period)
* Documented hypersensitivity to, or intolerance of, beta-agonists or 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 severe renal or 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

Primary Outcome Measures

Name	Time	Method
The change in forced oscillation technique (FOT) parameters (resistance and reactance) following administration of combination glycopyrronium/indacaterol compared to glycopyrronium alone[2 hours post-administration at each study visit];The change in forced oscillation technique (FOT) parameters (resistance and reactance) following administration of combination glycopyrronium/indacaterol compared to indacaterol alone[2 hours post-administration at each study visit]