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Trial registered on ANZCTR


Registration number
ACTRN12609000394246
Ethics application status
Approved
Date submitted
1/06/2009
Date registered
2/06/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of feather bedding on childhood asthma: a randomised controlled trial
Scientific title
The effect of feather bedding on childhood asthma: a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood asthma 4890 0
Condition category
Condition code
Respiratory 237245 237245 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents and children in the feather intervention group were supplied with and instructed to use only the feather pillow and quilt on a daily basis for 12 months, with no other forms of upper bedding apart from sheets. Consistent with usual practice, the duck feather and down bedding was commercially pre-washed in hot water, chemically treated and hot air dried by the manufacturer before use, with documentation of the procedures used. (Myer House Brand, Hangzhou, China). On hot nights, the replacement use of thin cotton covers was advised if needed. Feather pillows were used all year. A mite-occlusive cover (Auspharm, Australia) was fitted to the child's mattress.
Intervention code [1] 236678 0
Prevention
Comparator / control treatment
The control group received verbal advice from the research nurse at baseline explaining the then current bedding advice including house dust mite occlusive mattress covers may provide some benefit and synthetic pillows and quilts have been recommended for use in children with severe asthma. The advice was in accord with the National Asthma Campaign recommendations. In addition they were provided with a written set of instructions covering this advice. A mite-occlusive cover (Auspharm, Australia) was also fitted to the child's mattress. The control group were to use the mattress cover and the synthetic bedding for a period of 12 months.
Control group
Active

Outcomes
Primary outcome [1] 238058 0
the proportion of children reporting four or more episodes of wheeze in the 12 months post intervention assessed by standarised questionnaire adminsitered at baseline and at 12 months
Timepoint [1] 238058 0
12 months
Primary outcome [2] 238059 0
an episode of speech limiting wheeze in the 12 months post intervention assessed by standarised questionnaire adminsitered at baseline and at 12 months
Timepoint [2] 238059 0
12 months
Primary outcome [3] 238060 0
reporting one or more episodes of nocturnal wheeze in the 12 months post intervention assessed by standarised questionnaire adminsitered at baseline and at 12 months
Timepoint [3] 238060 0
12 months
Secondary outcome [1] 242247 0
Spirometry at both baseline and endpoint including Foreced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), the FEV1/FVC ratio and the relative and absolute change in FEV1 after challenge
Timepoint [1] 242247 0
12 months
Secondary outcome [2] 242248 0
quality of life assessments using the Juniper Paediatric Quality of Life Questionnaire
Timepoint [2] 242248 0
12 months post intervention

Eligibility
Key inclusion criteria
(1) aged 7 – 14 years;
(2) diagnosed with asthma;
(3) asthma symptoms that include wheeze; (4) four or more episodes of wheeze per year; or (5) have an episode of speech limiting wheeze in the past 12 months; (6) house dust mite (HDM) sensitised (wheal size of >= 3 mm to Der p 1 and/or Der f 1);
(7) sleep in a single bed; and (8) plan to remain in the study region for the next two years
Minimum age
7 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) sensitised to feather (wheal size of < 3 mm to feather extract );
(2) sensitised to cat (wheal size of < 3 mm to cat pelt extract) if there is a cat at home;
(3) having a feather pillow or quilt on their bed when entering the study;

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A block randomisation approach with age blocks by year of birth was used to balance age distribution in each arm and achieve method concealment. The randomisation procedure employed a “biased coin” method to minimise the likelihood that the chance of being allocated to the intervention differs by season. Research nurses conducting clinical assessments were blind to which group the children had been assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence was generated by an independent statistician with subjects randomized against this sequence by research nurses at the study sites.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patient blinding was achieved by providing an alternative intervention to the control group. Each participant, regardless of group allocation, was informed that they had been allocated to a bedding intervention with some preliminary medical literature support that it may benefit asthma. The analyses were first conducted by an independent statistician who had not been involved in the study design or progress in any way and was blind to which group was the intervention group and which the control group
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 5068 0
Government body
Name [1] 5068 0
National Health and Medical Research Council (NHMRC)
Address [1] 5068 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 5068 0
Australia
Primary sponsor type
University
Name
The Australian National University
Address
The Australian National University
Canberra ACT 0200
Australia
Country
Australia
Secondary sponsor category [1] 4577 0
Hospital
Name [1] 4577 0
The Children's Hospital at Westmead
Address [1] 4577 0
The Children's Hospital at Westmead, Locked Bag 4001, Westmead 2145
Country [1] 4577 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239169 0
Australian Capital Territory (ACT) Health Human Research Ethics Committee
Ethics committee address [1] 239169 0
GPO Box 825 Canberra ACT 2601
Ethics committee country [1] 239169 0
Date submitted for ethics approval [1] 239169 0
Approval date [1] 239169 0
20/08/2001
Ethics approval number [1] 239169 0
ETH.7/01.241
Ethics committee name [2] 239170 0
Sydney South West Area Health Service Human Research Ethics Committee
Ethics committee address [2] 239170 0
Locked Bag 7017 Liverpool BC, NSW 1871
Ethics committee country [2] 239170 0
Australia
Date submitted for ethics approval [2] 239170 0
Approval date [2] 239170 0
01/11/2002
Ethics approval number [2] 239170 0
Project Number 02/090
Ethics committee name [3] 239171 0
The Childrens' Hospital at Westmead Ethics Committee
Ethics committee address [3] 239171 0
Locked Bag 4001 Westmead NSW 2145
Ethics committee country [3] 239171 0
Australia
Date submitted for ethics approval [3] 239171 0
Approval date [3] 239171 0
28/02/2003
Ethics approval number [3] 239171 0
Project Number 2003/012

Summary
Brief summary
It is not clear whether children with asthma should be advised to avoid feather pillow and quilts in case feather bedding makes asthma symptoms worse. Some exploratory studies have suggested feather bedding might actually be better for children with asthma. The trial was designed to assess whether a new feather pillow and quilt was associated with a reduction in asthma severity among house dust mite sensitised children with asthma over a one year period compared to the use of non-feather bedding
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29676 0
Address 29676 0
Country 29676 0
Phone 29676 0
Fax 29676 0
Email 29676 0
Contact person for public queries
Name 12923 0
Nicholas Glasgow
Address 12923 0
Dean, Medicine and Health Sciences
College of Medicine, Biology and Environment
College of Physical Sciences
Dean, Medical School
Frank Fenner Building (42)
The Australian National University
CANBERRA ACT 0200 Australia
Country 12923 0
Australia
Phone 12923 0
61 2 61252622
Fax 12923 0
61 2 61254814
Email 12923 0
dean.medical.school@anu.edu.au
Contact person for scientific queries
Name 3851 0
Nicholas Glasgow
Address 3851 0
Dean, Medicine and Health Sciences
College of Medicine, Biology and Environment
College of Physical Sciences
Dean, Medical School
Frank Fenner Building (42)
The Australian National University
CANBERRA ACT 0200 Australia
Country 3851 0
Australia
Phone 3851 0
61 2 61252622
Fax 3851 0
61 2 61254814
Email 3851 0
dean.medical.school@anu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary