Not Yet RecruitingPhase 3ACTRN12610000080022

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

A randomised placebo crossover trial to compare the effects of nebulised salbutamol and ipratropium driven by air and oxygen on transcutaneous crabon dioxide (CO2) levels in patients with severe Chronic Obstructive Pulmonary Disease (COPD).

Sponsor

Medical Research Institute of New Zealand (MRINZ)

Enrollment

18 participants

Start Date

Feb 15, 2010

Study Type

Interventional

Conditions

COPD

Summary

Patients with COPD are sensitive to the effects of oxygen, especially so those who are on oxygen at home. When these patients suffer an exacerbation they are frequently given nebulisers in the anbulance whilst in transit to hospital. Nebulisers are often driven by oxygen, sometimes large amounts. On long journeys they may be given multiple nebulisations with high flows of oxygen. Our hypothesis is that this may increase CO2 to dangerous levels whereby patients are at risk of develeoping an altered state of conciousness. We aim to compare different flows of oxygen given with nebulisers to assess what effect this has on the CO2 of patients with COPD.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

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 Criteria4

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%

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Interventions

Subjects will attend on 2 separate days. On each day they will receive a nebuliser containing 5mg of salbutamol and 500mcg of ipratropium bromide followed after 5 minutes by another nebuliser containg 5mg salbutamol only. On 1 day the nebuliser will be driven by air and on the other day by 8L of oxygen. Patients attend on 2 seperate days so washout period will be at least 24 hours.