Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000623695
Ethics application status
Approved
Date submitted
16/09/2005
Date registered
10/10/2005
Date last updated
22/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does humidification reduce exacerbations for people with COPD and bronchiectasis?
Scientific title
Does home based humidification treatment reduce exacerbation frequency for people with COPD and bronchiectasis?
Secondary ID [1] 286036 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease. 750 0
bronchiectasis 294012 0
Condition category
Condition code
Respiratory 826 826 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily 2 hours humidifcation treatment over a 12 month treatment period. Humidified air, fully saturated at 37 degree Celsius is delivered at 20 L/min or 25 L/min NHF via a nasal cannula.
Intervention code [1] 630 0
None
Intervention code [2] 291021 0
Treatment: Devices
Comparator / control treatment
Usual care as control
Control group
Active

Outcomes
Primary outcome [1] 1058 0
To determine whether the delivery of humidified air for 2 or more hours per day at home can reduce exacerbation frequency for patients with COPD and bronchiectasis.
Timepoint [1] 1058 0
Assessed at baseline, 3 and 12 months
Secondary outcome [1] 1970 0
The secondary outcome is to determine whether the delivery of humidified air for 2 or more hours per day: Reduces hospital admissions for respiratory conditions.
Timepoint [1] 1970 0
Assessed at baseline, 3 and 12 months
Secondary outcome [2] 1971 0
The secondary outcome is to determine whether the delivery of humidified air for 2 or more hours per day: Reduces the number of exacerbation days over the 12 months.
Timepoint [2] 1971 0
Assessed at baseline, 3 and 12 months
Secondary outcome [3] 1972 0
The secondary outcome is to determine whether the delivery of humidified air for 2 or more hours per day: prolongs time to first exacerbation.
Timepoint [3] 1972 0
Assessed at baseline, 3 and 12 months
Secondary outcome [4] 1973 0
The secondary outcome is to determine whether the delivery of humidified air for 2 or more hours per day: Improves perceived quality of life over the 12 months
Timepoint [4] 1973 0
Assessed at baseline, 3 and 12 months
Secondary outcome [5] 312526 0
The secondary outcome is to determine whether the delivery of humidified air for 2 or more hours per day: Improves subject's lung function over the 12 months. Spirometry was used to assess patient's FEV1 according to ATS/ERS guideline.
Timepoint [5] 312526 0
Assessed at baseline, 3 and 12 months
Secondary outcome [6] 312527 0
The secondary outcome is to determine whether the delivery of humidified air for 2 or more hours per day: Improves subject's exercise capacity (6 Minute Walk Test) over the 12 months
Timepoint [6] 312527 0
Assessed at baseline, 3 and 12 months
Secondary outcome [7] 312528 0
The secondary outcome is to determine whether the delivery of humidified air for 2 or more hours per day: Improves subject's inflammatory markers (sputum cell counts) over the 12 months
Timepoint [7] 312528 0
Assessed at baseline, 3 and 12 months

Eligibility
Key inclusion criteria
COPD; FEV1<70% and FEV1/FVC ratio <70%, and, > 2 exacerbation over the last 12 months, and > 5mL daily sputum production. Bronchiectasis; diagnosis of bronchiectasis confirmed by CT, and, > 2 exacerbation over the last 12 months.

All subjects were recruited when stable with no sign of an exacerbation for at least 4 weeks.
Minimum age
20 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with significant comorbidity, bronchiectasis associated with cystic fibrosis or hypo-gammaglobulinemia were excluded.

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)
Sealed envelope, concealed until assigned, no stratification, randomization by 12-sided die (ignoring 12, allocating active treatment to 1-6 and control to 7-11) with block size 11 (6 treated patients to 5 control patients)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer package
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
1/08/2004
Actual
27/10/2004
Date of last participant enrolment
Anticipated
Actual
31/07/2005
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment outside Australia
Country [1] 229 0
New Zealand
State/province [1] 229 0

Funding & Sponsors
Funding source category [1] 914 0
Charities/Societies/Foundations
Name [1] 914 0
Foundation for Research Science and Technology
Country [1] 914 0
New Zealand
Funding source category [2] 915 0
Commercial sector/Industry
Name [2] 915 0
Fisher & Paykel Healthcare
Country [2] 915 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki 2013
Auckland
Country
New Zealand
Secondary sponsor category [1] 773 0
Hospital
Name [1] 773 0
CCREP (Middlemore Hospital)
Address [1] 773 0
Esme Green Building
Middlemore Hospital
Hospital Rd
Papatoetoe, Auckland 2025
Country [1] 773 0
New Zealand

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Persistent airway inflammation with mucus retention in patients with chronic airway disorders such as COPD and bronchiectasis may lead to frequent exacerbations, reduced lung function and poor quality of life. This study investigates if long-term humidification therapy with high flow fully humidified air at 37 C through nasal cannulae can improve these clinical
outcomes in this group of patients.
Trial website
Trial related presentations / publications
Rea H, et al., The clinical utility of long-term humidification therapy in chronic airway disease,. Respiratory Medicine (2010)
Public notes

Contacts
Principal investigator
Name 35198 0
Dr Harold Rea
Address 35198 0
The University of Auckland, Private Bag 92019,
Auckland 1142, NZ
Country 35198 0
New Zealand
Phone 35198 0
+64 (0) 9 373 7599
Fax 35198 0
Email 35198 0
[email protected]
Contact person for public queries
Name 9819 0
Ms Sue McAuley
Address 9819 0
Centre for Clinical Research and Effective Practice (CCREP)
Middlemore Hospital
Private Bag 93311
Otahuhu Auckland
Country 9819 0
New Zealand
Phone 9819 0
+64 9 2760000
Fax 9819 0
Email 9819 0
[email protected]
Contact person for scientific queries
Name 747 0
Mr Kevin O'Donnell
Address 747 0
Fisher & Paykel Healthcare 15 Maurice Paykel Place East Tamaki Auckland 2013
Country 747 0
New Zealand
Phone 747 0
+64 9 5740123
Fax 747 0
Email 747 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
No additional documents have been identified.