Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000149460
Ethics application status
Approved
Date submitted
23/02/2007
Date registered
28/02/2007
Date last updated
28/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Salbutamol delivered via Metered Dose Inhaler and Spacer versus Nebuliser to induce bronchodilatation during spirometry
Scientific title
Salbutamol delivered via Metered Dose Inhaler and Spacer versus Nebuliser to induce bronchodilatation during spirometry
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 1643 0
Chronic Obstructive Pulmonary Disease (COPD) 1644 0
Condition category
Condition code
Respiratory 1753 1753 0 0
Asthma
Respiratory 1754 1754 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1599 0
Diagnosis / Prognosis
Comparator / control treatment
The patients will be challenged with Salbutamol 5mg nebules (control). 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.
Control group
Active

Outcomes
Primary outcome [1] 2448 0
Compare the measured airway reversibility between the two methods of bronchodilator delivery.
Timepoint [1] 2448 0
Measured after each intervention. When the patients receive the MDI and spacer, with each dose increment (as above), spirometry will be measured.
Secondary outcome [1] 4213 0
1- Establish the equivalent dose of Salbutamol given via MDI and spacer to that of a nebuliser.
Timepoint [1] 4213 0
This analysis will be performed at the end of the trial after collecting all data.
Secondary outcome [2] 4214 0
2- Compare the safety of both methods of delivery.
Timepoint [2] 4214 0
Secondary outcome [3] 4215 0
Side effects such as tachycardia, tremor, sweatiness, respiratory distress or any other discomfort reported by the patient will be monitored immediately after each intervention and in the MDI group after each dose. A routine measurement will be the pulse rate following each dose.
Timepoint [3] 4215 0

Eligibility
Key inclusion criteria
All patients with known asthma or chronic obstructive airways disease (COPD) are eligible to be enrolled in the study.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1904 0
Hospital
Name [1] 1904 0
Respiratory Department, Box Hill Hospital
Country [1] 1904 0
Australia
Primary sponsor type
Hospital
Name
Respiratory Department, Box Hill Hospital
Address
Country
Australia
Secondary sponsor category [1] 1719 0
None
Name [1] 1719 0
Nil
Address [1] 1719 0
Country [1] 1719 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3550 0
Box Hill Hospital Ethics committee
Ethics committee address [1] 3550 0
Ethics committee country [1] 3550 0
Australia
Date submitted for ethics approval [1] 3550 0
Approval date [1] 3550 0
10/10/2006
Ethics approval number [1] 3550 0
E16/0607

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27533 0
Address 27533 0
Country 27533 0
Phone 27533 0
Fax 27533 0
Email 27533 0
Contact person for public queries
Name 10788 0
Dr Murad Ibrahim
Address 10788 0
Box Hill Hospital, Nelson Rd, Box Hill, VIC, 3128 ( till 4/2/06)Austin Health, Studley Rd, Heidelberg, VIC 3084 (from 5/2/06)
Country 10788 0
Australia
Phone 10788 0
Box Hill hospital: 03 98953333Austin Health: 03 94965000
Fax 10788 0
Email 10788 0
muradibrahim@hotmail.com
Contact person for scientific queries
Name 1716 0
Dr Murad Ibrahim
Address 1716 0
Box Hill Hospital, Nelson Rd, Box Hill, VIC, 3128 ( till 4/2/06)Austin Health, Studley Rd, Heidelberg, VIC 3084 (from 5/2/06)
Country 1716 0
Australia
Phone 1716 0
Box Hill hospital: 03 98953333Austin Health: 03 94965000
Fax 1716 0
Email 1716 0
muradibrahim@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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