A randomised trial of air and oxygen driven nebulised salbutamol and ipratropium in Chronic Obstructive Pulmonary Disease (COPD).

Phase 3

• Conditions: COPD; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12610000080022
• Lead Sponsor: Medical Research Institute of New Zealand (MRINZ)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Diagnosis of COPD according to British Thoracic Society (BTS) criteria
Pre-bronchodilator forced expiratory volume in 1 second (FEV1) less than or equal to 40% of predicted

Exclusion Criteria

History of allergy/sensitivity to study drugs
On warfarin
Concurrent risk factors for hypercapnic respiratory failure (Body Mass Index >40, chest wall restriction, severe musculoskeletal weakness)
Those needing >4L oxygen via nasal cannulae to keep saturations >88%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in transcutaneous CO2 level (tCO2). Assessed by use of TOSCA machine. Please not TOSCA is a tradename not an acronym.[T=35 minutes. Following administration of second nebuliser.]

Secondary Outcome Measures

Name	Time	Method
umber of patients experiencing a rise in tCO2 >10mmHg and clinical symptoms; defined as a fall in Glasgow Coma Score (GCS) of 1 point or a fall in Abbreviated Mental Test Score (AMT) <7/10.[T= 35 minutes. Following administration of second nebuliser.]