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Salbutamol delivered via Metered Dose Inhaler and Spacer versus Nebuliser to induce bronchodilatation during spirometry

Salbutamol delivered via Metered Dose Inhaler and Spacer versus Nebuliser to induce bronchodilatation during spirometry

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000149460
Enrollment
40
Registered
2007-02-28
Start date
2007-02-01
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

Testing for bronchodilator response (airway reversibility) is an essential part of spirometry. Traditionally respiratory laboratories use nebulised salbutamol to check such response. New data suggest that inhaled salbutamol via metered dose inhaler and spacer is at least as effective as nebulised salbutamol and may be associated with fewer side effects. Comparison between the two methods of inducing bronchodilatation in the laboratory has not been previously tested. We aim to compare the 2 methods of delivery for bronchodilator response. The patients will be monitored for any potential side effects during the study.

Interventions

The study aims at comparing 2 methods of bronchodilator challenge in patients with asthma or COPD. The patients will be challenged with Salbutamol 200-800 mcg via metered dose inhaler (MDI) and spacer (intervention). During the latter part each patient will receive an incremental dose of Salbutamol MDI and spacer starting from 200mcg and increasing by further 200mcg each time, up to 800mc

The study aims at comparing 2 methods of bronchodilator challenge in patients with asthma or COPD. The patients will be challenged with Salbutamol 200-800 mcg via metered dose inhaler (MDI) and spacer (intervention). During the latter part each patient will receive an incremental dose of Salbutamol MDI and spacer starting from 200mcg and increasing by further 200mcg each time, up to 800mcg in total. The patients will have spirometry after each dose which will be given 5-10 minutes apart. Airway reversibility will be measured during spirometry and side effects monitored. The patients are tested on 2 separate days spending approximately one hour each time. They will be asked to come back within the same week starting from the following day, at approximately the same time of day to control for diurnal variation in respiratory function.

Sponsors

Respiratory Department, Box Hill Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

All patients with known asthma or chronic obstructive airways disease (COPD) are eligible to be enrolled in the study.

Exclusion criteria

The following categories of patients will be excluded from the study:• Patients under 18 years of age• Known pregnancy• Breast feeding• Known allergy to Salbutamol• Having had the following bronchodilators within the specified times below:o Salbutamol within 8 hours of the testo Long acting B-agonist (Salmeterol or Eformoterol) and theophylline within 24 hourso Tiotropium within 72 hourso Montelukast within 4 days.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026