Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000348358
Ethics application status
Approved
Date submitted
27/06/2008
Date registered
23/07/2008
Date last updated
2/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of continuous positive airway pressure treatment on markers of systemic inflammation, pulmonary function and respiratory-related quality of life, in patients with combined chronic obstructive pulmonary disease and obstructive sleep apnea, a parallel group randomized trial
Scientific title
The effect of continuous positive airway pressure treatment compared with usual therapy on markers of systemic inflammation, pulmonary function and respiratory-related quality of life in patients with combined chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), a parallel group randomized trial.
Secondary ID [1] 284334 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 3323 0
Obstructive sleep apnoea 3324 0
Overlap syndrome 3325 0
Systemic inflammation 3326 0
Chronic obstructive pulmonary disease
Obstructive sleep apnoea
Overlap syndrome 3327 0
Respiratory function 3328 0
Condition category
Condition code
Respiratory 3482 3482 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised, parallel-group, controlled trial of the addition of 6 months continuous positive airway pressure (CPAP) therapy, in addition to usual medical care for COPD.
Primary hypothesis:
Treatment of moderate to severe OSA with CPAP in patients with Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (GOLD) Stage III or IV COPD leads to reduced systemic inflammation.

Secondary hypotheses:
This reduction in inflammation is associated with an improvement in respiratory outcomes (Quality of life, symptoms) in COPD. CPAP therapy is well-tolerated in COPD patients with significant OSA. CPAP therapy is used each night during sleep. It is a device which produces pressurised air, which is delivered through a nasal or face mask. It should be worn each night during sleep for the 6 month duration of the study. The pressure will vary between individuals. This pressure shall be determined by an overnight titration sleep study at the baseline study visit.
Intervention code [1] 3061 0
Treatment: Devices
Comparator / control treatment
The comparator treatment group will have usual medical care for COPD according to internationally recognised Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (GOLD) guidelines, including inhalers and pulmonary rehabilitation.
Control group
Active

Outcomes
Primary outcome [1] 4388 0
High sensitivity C-reactive Protein (CRP) measured by blood sampling
Timepoint [1] 4388 0
Week 0, 6, 12, 24 from baseline visit
Secondary outcome [1] 7403 0
Quality of life variables from questionnaires Modified Medical Research Council (MMRC)
Transitional dyspnoea questionnaire/Baseline dyspnoea questionnaire (TDI/BDI)
36-item short-form health survey (SF36)
Pittsburgh Sleep Quality Index (PSQI)
Epworth Sleepiness Scale (ESS)
St George Respiratory Questionnaire (SGRQ)
Timepoint [1] 7403 0
Weeks 0, 6, 12, 24 from baseline visit
Secondary outcome [2] 7404 0
Lung function outcomes
Testing will consist of:
- spirometry (prior to and after 400 mcg salbutamol),
- lung volumes (by body plethysmography),
- diffusing capacity for carbon monoxide,
- respiratory system resistance and reactance by forced oscillation technique,
- hypertonic saline challenge,
- sputum induction
- exhaled nitric oxide assay.
Timepoint [2] 7404 0
Weeks 0, 6, 12, 24 from baseline visit
Secondary outcome [3] 7405 0
Number of exacerbations of COPD and medication use
Timepoint [3] 7405 0
Weeks 0, 6, 12, 24 from baseline visit
Secondary outcome [4] 7406 0
Other serum (blood sample analysis)inflammatory markers (eg. Adipokines, IL-6, IL-8 and TNF-alpha, insulin resistance (homeostatic model assessment))
Timepoint [4] 7406 0
Weeks 0, 6, 12, 24 from baseline visit

Eligibility
Key inclusion criteria
1. Age >= 18 years
2. GOLD Stage III or IV (severe COPD): post-bronchodilator forced expiratory volume in 1 second/forced vital (FEV1/FVC) < 0.70, FEV1 <50% predicted.
3. An established clinical history of COPD
4. Ex-smokers with a smoking history of at least 10 pack-years. Ex-smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
5. Moderate to severe Obstructive Sleep Apnoea (Apnoea Hypopnea Index >= 15)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A subject will not be eligible for inclusion in this study if any of
the following criteria apply:
-Subjects who have a moderate exacerbation (that required systemic corticosteroid therapy or antibiotics) of COPD in the previous month or a severe exacerbation (that required hospitalization) in the 3 months prior to baseline visit.
-Current respiratory disorders other than COPD and asthma (e.g., lung cancer, sarcoidosis, tuberculosis, lung fibrosis, bronchiectasis)
-Had lung-volume reduction surgery and/or a lung transplant
-Requirement for nocturnal non-invasive ventilation or long term oxygen therapy (defined as oxygen therapy prescribed for 12 hours or more per day) at start of study
-Receiving long-term oral corticosteroid therapy (defined as continuous use for greater than 6 weeks. Courses of oral corticosteroids separated by a period of less than 7 days will be considered as continuous use).
- Severe OSA (minimum oxygen saturation < 65% or Respiratory Disturbance Index (RDI) > 80) requiring immediate treatment due to severity or increased associated risk (eg Transport worker
-Current treatment with CPAP (defined as CPAP usage within 3 months of baseline visit).
-Unwilling to use CPAP therapy.
-Serious, uncontrolled non-respiratory disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the 6-month study duration.
-Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
-Participation in any other interventional research study in the last 4 weeks before baseline visit.

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)
Allocation concealment will be achieved by the use of opaque, sealed envelopes. The randomisation list and preparation of the sealed envelopes will be by an individual not involved with the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation list will be generated by computer program using random permuted blocks. There will be stratification by study centre (Sydney or Newcastle).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2008
Actual
13/11/2009
Date of last participant enrolment
Anticipated
Actual
25/08/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 920 0
2050

Funding & Sponsors
Funding source category [1] 3530 0
Other
Name [1] 3530 0
NHMRC Centre for Clinical Research Excellence in respiratory and sleep
Country [1] 3530 0
Australia
Primary sponsor type
Other
Name
NHMRC Centre for Clinical Research Excellence in respiratory and sleep
Address
Woolcock Institute of Medical Research
PO Box M77, Missenden Road, 2050 NSW
Country
Australia
Secondary sponsor category [1] 3168 0
Hospital
Name [1] 3168 0
Department of Respiratory Medicine
Address [1] 3168 0
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country [1] 3168 0
Australia
Secondary sponsor category [2] 3191 0
Hospital
Name [2] 3191 0
Department of Sleep and Respiratory Medicine
Address [2] 3191 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country [2] 3191 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5567 0
South-West Sydney Area Health Service Ethics Review Committee
Ethics committee address [1] 5567 0
Research Development Office
Level 8, Building 14
Royal Prince Alfred Hospital
CAMPERDOWN NSW 2050
Ethics committee country [1] 5567 0
Australia
Date submitted for ethics approval [1] 5567 0
Approval date [1] 5567 0
11/06/2008
Ethics approval number [1] 5567 0
HREC Ref. 08/RPAH/190

Summary
Brief summary
In this study, we aim to improve the evidence-based management of moderate to severe COPD patients with concurrent obstructive sleep apnea.
Our primary hypothesis: Treatment of moderate to severe OSA with CPAP in patients with GOLD Stage III COPD leads to reduced systemic inflammation.
Our secondary hypotheses:
1. This reduction in inflammation is associated with an improvement in respiratory outcomes (Quality of life, symptoms) in COPD.
2. CPAP therapy is well-tolerated in COPD patients with significant OSA.
Trial website
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 28708 0
Dr Keith Wong
Address 28708 0
Dept of Respiratory Medicine Royal Prince Alfred Hospital Missenden Road Camperdown NSW 2050
Country 28708 0
Australia
Phone 28708 0
+61 2 9114 0445
Fax 28708 0
Email 28708 0
keithw@woolcock.org.au
Contact person for public queries
Name 11865 0
Sarah Newton-John
Address 11865 0
Clinical Research Operations Group
Woolcock Institute of Medical Research
PO Box 77, Missenden Road, Camperdown, NSW 2050
Country 11865 0
Australia
Phone 11865 0
+61 2 9114 0436
Fax 11865 0
+61 2 9114 0011
Email 11865 0
sarahnj@woolcock.org.au
Contact person for scientific queries
Name 2793 0
Dr Keith Wong
Address 2793 0
Dept of Respiratory Medicine
Royal Prince Alfred Hospital
Missenden Road
Camperdown
NSW 2050
Country 2793 0
Australia
Phone 2793 0
+61 2 9114 0445
Fax 2793 0
+61 2 9515 8196
Email 2793 0
keithw@woolcock.org.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

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