Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000666022
Ethics application status
Approved
Date submitted
21/06/2010
Date registered
16/08/2010
Date last updated
28/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacotherapy for the Different Phenotypes of Airways Disease
Scientific title
In a random community sample of people 18-75 years with wheeze and dyspnea, does the response to salbutamol 400 mcg once, iprotropium 80 mcg once or budesonide 800 mcg daily for 12 weeks differ between airways disease phenotypes in lung function, disease control and quality of life?
Secondary ID [1] 252067 0
N/A
Universal Trial Number (UTN)
U1111-1115-5424
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 257604 0
Chronic obstructive pulmonary disease (COPD) 257605 0
Airways disease 257606 0
Condition category
Condition code
Respiratory 257780 257780 0 0
Asthma
Respiratory 257781 257781 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Ipratropium 80 mcg inhaled single dose
2.Salbutamol 400 mcg inhaled single dose
3. Budesonide 400 mcg inhaled twice daily for 12 weeks

All participants will receive all interventions in the sequence 1, 2, 3. Interventions 1 and 2 to be administered 1-4 weeks apart. Intervention 3 to be administered over the 12 weeks immediately following intervention 2.
Intervention code [1] 256693 0
Treatment: Drugs
Comparator / control treatment
The effect of each of the three interventions will be compared across phenotype groups. All participants will receive the same three interventions in the same order; effectively there will be three independent uncontrolled trials. No control intervention or comparison between interventions is planned.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258649 0
difference in forced expiratory volume in one second (FEV1) response to ipratropium between groups. This will be measured by spirometry.
Timepoint [1] 258649 0
At baseline and 30 minutes following administration of ipratropium.
Primary outcome [2] 258654 0
difference in FEV1 response to salbutamol between groups. This will be measured by spirometry.
Timepoint [2] 258654 0
At baseline and 30 minutes following administration of salbutamol.
Secondary outcome [1] 264628 0
Change in symptoms and control of airways disease in response to inhaled corticosteroid as measured by Asthma Control Questionnaire.
Timepoint [1] 264628 0
At baseline and 12 weeks following commencement of treatent.

Eligibility
Key inclusion criteria
selected at random from the electoral register
wheeze and shortness of breath in the last 12 months
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable or unwilling to withhold medication prior to study visits. Hypersensitivity to study drug.

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Cluster analysis will be used to identify phenotypes of airways disease in the community. Patterns of response of respiratory medications will be compared between the identified clusters.

The study protocol and analysis plan are available on request by e-mail from the co-ordinating investigator.The analysis plan has been finalised prior to the completion of data collection no interim analyses have been performed.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/11/2010
Actual
15/11/2010
Date of last participant enrolment
Anticipated
Actual
3/12/2012
Date of last data collection
Anticipated
Actual
3/12/2012
Sample size
Target
16500
Accrual to date
Final
16459
Recruitment outside Australia
Country [1] 2704 0
New Zealand
State/province [1] 2704 0
Wellington

Funding & Sponsors
Funding source category [1] 257163 0
Government body
Name [1] 257163 0
Health Research Council
Country [1] 257163 0
New Zealand
Funding source category [2] 286651 0
Commercial sector/Industry
Name [2] 286651 0
AstraZeneca New Zealand
Country [2] 286651 0
New Zealand
Funding source category [3] 286652 0
Commercial sector/Industry
Name [3] 286652 0
AstraZeneca AB
Country [3] 286652 0
Sweden
Funding source category [4] 286653 0
Charities/Societies/Foundations
Name [4] 286653 0
Asthma Foundation
Country [4] 286653 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Reseach Institute of New Zealand
Address
Private Bag 7902, Wellington 6242, New Zealand
Country
New Zealand
Secondary sponsor category [1] 256418 0
None
Name [1] 256418 0
N/A
Address [1] 256418 0
N/A
Country [1] 256418 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259203 0
Central regional Ethics Committee
Ethics committee address [1] 259203 0
Ethics committee country [1] 259203 0
New Zealand
Date submitted for ethics approval [1] 259203 0
01/12/2009
Approval date [1] 259203 0
02/11/2010
Ethics approval number [1] 259203 0
CEN/09/12/095

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31311 0
Dr James Fingleton
Address 31311 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 31311 0
New Zealand
Phone 31311 0
+6448050147
Fax 31311 0
+64 4 389 5707
Email 31311 0
[email protected]
Contact person for public queries
Name 14558 0
James Fingleton
Address 14558 0
Private Bag 7902, Wellington 6242
Country 14558 0
New Zealand
Phone 14558 0
64 4 8050147
Fax 14558 0
Email 14558 0
[email protected]
Contact person for scientific queries
Name 5486 0
James Fingleton
Address 5486 0
Private Bag 7902, Wellington 6242
Country 5486 0
New Zealand
Phone 5486 0
64 4 8050147
Fax 5486 0
Email 5486 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTreatment responsiveness of phenotypes of symptomatic airways obstruction in adults.2015https://dx.doi.org/10.1016/j.jaci.2015.01.013
EmbaseSerum periostin in obstructive airways Disease.2016https://dx.doi.org/10.1183/13993003.01384-2015
EmbasePhenotypes of symptomatic airways disease in China and New Zealand.2017https://dx.doi.org/10.1183/13993003.00957-2017
N.B. These documents automatically identified may not have been verified by the study sponsor.