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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).

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000080022
Enrollment
18
Registered
2010-01-22
Start date
2010-02-15
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Sponsors

Medical Research Institute of New Zealand (MRINZ)
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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%

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 27, 2026