Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000205639
Ethics application status
Approved
Date submitted
18/08/2005
Date registered
23/08/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian Trial of Ventilation in Chronic Airflow Limitation
Scientific title
Effect of home ventilatory support on clinical outcomes for patients on long term home oxygen therapy.
Universal Trial Number (UTN)
Trial acronym
AVCAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic airflow limitation 286 0
Condition category
Condition code
Respiratory 323 323 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A comparison of non-invasive nasal ventilation (NIV) during sleep plus long term oxygen therapy (LTOT) versus LTOT alone. The trial takes place over 2 years. In the intervention group, NIV is administered continuously during sleep every night during the trial.
Intervention code [1] 213 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 378 0
Survival
Timepoint [1] 378 0
At 2 years.
Secondary outcome [1] 838 0
Daytime blood gases
Timepoint [1] 838 0
Measured at 6 monthly intervals
Secondary outcome [2] 839 0
Lung function
Timepoint [2] 839 0
Measured at 6 monthly intervals
Secondary outcome [3] 840 0
Treatment compliance
Timepoint [3] 840 0
Measured at 6 monthly intervals
Secondary outcome [4] 841 0
Quality of life
Timepoint [4] 841 0
Measured at 6 monthly intervals

Eligibility
Key inclusion criteria
Chronic Airflow Limitation (FEV1< 1.5 or < 50% Predicted; FEV1/FVC < 60%, TLC > 92%; FEV1 with bronchodilators < 20%)+Daytime awake PaCO2 >46 mm Hg at least twice in the previous 6 months during periods of clinical stability;+Willing and competent to sign informed consent.+Under 80 years of age+On oxygen therapy for a minimum of three months prior to enrollment.
Minimum age
Not stated
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious coexisting disease (eg. left ventricular failure, malignancy, renal failure, unstable angina) likely to affect survival during the study period+Significant Obstructive Sleep Apnea (defined as Apnoea/hypopoea index >20/h) or Obesity Hypoventilation Syndrome +Significant recent psychological or psychiatric problems likely to significantly impair ability to participate in the study and comply with treatment; +Previous treatment with NIV.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No concealment following randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequential envelopes containing random allocations prepared by an independent party
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/1998
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 380 0
Government body
Name [1] 380 0
NHMRC grant, Application number: 98 1918 (1998-2000)
Country [1] 380 0
Australia
Funding source category [2] 381 0
Government body
Name [2] 381 0
NHMRC grant, Application number: 138404 (2001-2002)
Country [2] 381 0
Australia
Funding source category [3] 382 0
Commercial sector/Industry
Name [3] 382 0
Airliquide
Country [3] 382 0
Primary sponsor type
Individual
Name
Professor RD McEvoy MD, MBBS
Address
Director
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daw Park SA
Country
Australia
Secondary sponsor category [1] 305 0
Individual
Name [1] 305 0
Associate Professor RR Grunstein MBBS, FRACP, MD, PhD, Clinical Associate Professor/Senior Staff Specialist
Address [1] 305 0
Centre for Respiratory Failure and Sleep Disorders
Royal Prince Alfred Hospital
Camperdown NSW
Country [1] 305 0
Australia
Secondary sponsor category [2] 306 0
Individual
Name [2] 306 0
Dr Elizabeth Ellis M.Sc, PhD, Senior Lecturer
Address [2] 306 0
School of Physiotherapy
Faculty of Health Sciences
University of Sydney
Country [2] 306 0
Australia
Secondary sponsor category [3] 307 0
Individual
Name [3] 307 0
Professor RJ Pierce, Head of Respiratory and Sleep Medicine
Address [3] 307 0
Austin and Repatriation Medical Centre
Melbourne VIC
Country [3] 307 0
Australia
Secondary sponsor category [4] 308 0
Individual
Name [4] 308 0
Dr D Hillman, Director of the Respiratory Physiology Department and Sleep Medicine Service
Address [4] 308 0
Sir Charles Gairdner Hospital
Perth WA
Country [4] 308 0
Australia
Secondary sponsor category [5] 309 0
Individual
Name [5] 309 0
Mr A Esterman MSc, Cstat, DLSHTM, Senior Research Fellow
Address [5] 309 0
Department of General Practice
Flinders University
Adelaide SA
Country [5] 309 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1369 0
Repatriation General Hospital
Ethics committee address [1] 1369 0
Ethics committee country [1] 1369 0
Australia
Date submitted for ethics approval [1] 1369 0
Approval date [1] 1369 0
Ethics approval number [1] 1369 0
Ethics committee name [2] 1370 0
Royal Prince Alfred Hospital
Ethics committee address [2] 1370 0
Ethics committee country [2] 1370 0
Australia
Date submitted for ethics approval [2] 1370 0
Approval date [2] 1370 0
Ethics approval number [2] 1370 0
Ethics committee name [3] 1371 0
Austin and Repatriation Hospital
Ethics committee address [3] 1371 0
Ethics committee country [3] 1371 0
Australia
Date submitted for ethics approval [3] 1371 0
Approval date [3] 1371 0
Ethics approval number [3] 1371 0
Ethics committee name [4] 1372 0
Sir Charles Gairdner Hospital
Ethics committee address [4] 1372 0
Ethics committee country [4] 1372 0
Australia
Date submitted for ethics approval [4] 1372 0
Approval date [4] 1372 0
Ethics approval number [4] 1372 0
Ethics committee name [5] 1373 0
The Royal Adelaide Hospital
Ethics committee address [5] 1373 0
Ethics committee country [5] 1373 0
Australia
Date submitted for ethics approval [5] 1373 0
Approval date [5] 1373 0
Ethics approval number [5] 1373 0
Ethics committee name [6] 1374 0
Queen Elizabeth Hospital
Ethics committee address [6] 1374 0
Ethics committee country [6] 1374 0
Australia
Date submitted for ethics approval [6] 1374 0
Approval date [6] 1374 0
Ethics approval number [6] 1374 0
Ethics committee name [7] 1375 0
The Alfred and Hospital
Ethics committee address [7] 1375 0
Ethics committee country [7] 1375 0
Australia
Date submitted for ethics approval [7] 1375 0
Approval date [7] 1375 0
Ethics approval number [7] 1375 0
Ethics committee name [8] 1376 0
Flinders University
Ethics committee address [8] 1376 0
Ethics committee country [8] 1376 0
Australia
Date submitted for ethics approval [8] 1376 0
Approval date [8] 1376 0
Ethics approval number [8] 1376 0

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

Contacts
Principal investigator
Name 35261 0
Address 35261 0
Country 35261 0
Phone 35261 0
Fax 35261 0
Email 35261 0
Contact person for public queries
Name 9402 0
Professor R Doug McEvoy
Address 9402 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daw Park SA 5041
Country 9402 0
Australia
Phone 9402 0
+61 8 82751187
Fax 9402 0
+61 8 82776890
Email 9402 0
Doug.McEvoy@rgh.sa.gov.au
Contact person for scientific queries
Name 330 0
Professor R Doug McEvoy
Address 330 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daw Park SA 5041
Country 330 0
Australia
Phone 330 0
+61 8 82751187
Fax 330 0
+61 8 82751187
Email 330 0
Doug.McEvoy@rgh.sa.gov.au

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
No additional documents have been identified.