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Trial registered on ANZCTR


Registration number
ACTRN12609000551291
Ethics application status
Approved
Date submitted
6/07/2009
Date registered
7/07/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of regular paracetamol on asthma symptoms in mild to moderate asthma
Scientific title
A randomised, double-blind, placebo-controlled study to investigate the effect of regular paracetamol on airway responsiveness and asthma control in mild to moderate asthma
Secondary ID [1] 273244 0
PA01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 4241 0
Condition category
Condition code
Respiratory 4463 4463 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects randomised to the intervention group will receive paracetamol tablets (1g dose) twice daily for 12 weeks.
Intervention code [1] 3965 0
Treatment: Drugs
Comparator / control treatment
Subjects randomised to the control group will receive placebo tablets (calcium hydrogen phosphate-cellulose dummy pills made to match a 500mg paracetamol tablet) twice daily for 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 5343 0
Bronchial hyper-responsiveness assessed using a methacholine challenge test.
Timepoint [1] 5343 0
12 weeks after commencement of treatment
Secondary outcome [1] 8981 0
Forced expiratory volume in 1 second (FEV1) as assessed by spirometry.
Timepoint [1] 8981 0
6 and 12 weeks after commencement of treatment.
Secondary outcome [2] 8982 0
Asthma symptom control as assessed using the Asthma Control Questionnaire score
Timepoint [2] 8982 0
6 and 12 weeks after commencement of treatment.
Secondary outcome [3] 9295 0
Fraction of exhaled nitric oxide (FeNo) measured using a chemoluminescence analyser.
Timepoint [3] 9295 0
6 and 12 weeks after commencement of treatment
Secondary outcome [4] 9296 0
Exacerbations of asthma requiring a visit to a doctor and the need for prednisone or nebulised bronchodilators (this data will be collected during study investigator interviews of the subject, and from a review of subject completed questionnaires and General Practitioner reports).
Timepoint [4] 9296 0
Monitored throughout the 12 weeks of the study
Secondary outcome [5] 244586 0
Mean morning and evening peak flow as measured by the subject using a peak-flow meter and calculated from 3 morning and 3 evening readings.
Timepoint [5] 244586 0
Peak flows will be measured for the first 7 days of the study compared with the measures taken during the last 7 days of the study (week 11-12).

Eligibility
Key inclusion criteria
1. Wheeze in the past 12 months and a doctor's diagnosis of asthma 2. Baseline FEV1 greater than or equal to 70% predicted 3. Provocative concentration of methacholine required to achieve a 20% fall in FEV1 (PC20 methacholine) of between 0.125-16.0 mg/ml
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients taking theophylline, ipratropium bromide, tiotropium or leukotriene receptor antagonists regularly in the previous 3 months. 2. An exacerbation of asthma within the previous two months requiring prednisone or nebulised bronchodilator. 3.Current or past cigarette smoking greater than 10 pack years (pack years are calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked). 4.History of allergy or sensitivity to paracetamol or opiates or a history of allergy or sensitivity to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) in subjects who have never taken paracetamol. 5. Current or past history of liver disease or on potentially hepatotoxic drugs. 6. Current use of regular paracetamol, or aspirin greater than 150 mg/day, or high doses of NSAIDs in patients who are unable to discontinue this use during the trial. 7. History of alcoholism, or current excessive alcohol intake. 8. Previous intentional acute overdose of paracetamol, previous suicide attempt or current depression. 9. Evidence of malnutrition or Body Mass Index (BMI) < 16 kg/m2. 10. Pregnant or breastfeeding women or women of child-bearing age not using adequate contraception. 11. Subjects with a screening alanine aminotransferase level above the normal reference range or other screening liver function test abnormalities considered significant by the investigator. 12. Subjects unsuitable for bronchial hyperresponsiveness challenge testing.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
13/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment outside Australia
Country [1] 1549 0
New Zealand
State/province [1] 1549 0

Funding & Sponsors
Funding source category [1] 4583 0
Charities/Societies/Foundations
Name [1] 4583 0
Medical Research Institute of New Zealand
Country [1] 4583 0
New Zealand
Funding source category [2] 237230 0
Charities/Societies/Foundations
Name [2] 237230 0
Wellington Medical Research Foundation Incorporated
Country [2] 237230 0
New Zealand
Funding source category [3] 237231 0
Government body
Name [3] 237231 0
Health Research Council of New Zealand
Country [3] 237231 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Level 7, CSB Building, Wellington Hospital, Riddiford Street, Newtown, Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 4132 0
None
Name [1] 4132 0
Address [1] 4132 0
Country [1] 4132 0
Other collaborator category [1] 739 0
University
Name [1] 739 0
Wellington Asthma Research Group
Address [1] 739 0
University of Otago Wellington School of Medicine and Health Sciences
23 Mein Street
Newtown
Wellington 6021
Country [1] 739 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6630 0
Central Regional Ethics Committee
Ethics committee address [1] 6630 0
Ethics committee country [1] 6630 0
New Zealand
Date submitted for ethics approval [1] 6630 0
19/11/2008
Approval date [1] 6630 0
19/06/2009
Ethics approval number [1] 6630 0
CEN/08/12/070

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

Contacts
Principal investigator
Name 29223 0
Address 29223 0
Country 29223 0
Phone 29223 0
Fax 29223 0
Email 29223 0
Contact person for public queries
Name 12470 0
Sally Eyers
Address 12470 0
Medical Research Institute of New Zealand, Level 7, CSB Building, Wellington Hospital, Riddiford Street, Newtown, Wellington 6021
Country 12470 0
New Zealand
Phone 12470 0
+64 4 805 0239
Fax 12470 0
+64 4 389 5707
Email 12470 0
sally.eyers@ccdhb.org.nz
Contact person for scientific queries
Name 3398 0
Sally Eyers
Address 3398 0
Medical Research Institute of New Zealand, Level 7, CSB Building, Wellington Hospital, Riddiford Street, Newtown, Wellington 6021
Country 3398 0
New Zealand
Phone 3398 0
+64 4 805 0239
Fax 3398 0
+64 4 389 5707
Email 3398 0
sally.eyers@ccdhb.org.nz

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
EmbaseThe effect of 1g of acetaminophen twice daily for 12weeks on alanine transaminase levels-A randomized placebo-controlled trial.2015https://dx.doi.org/10.1016/j.clinbiochem.2015.04.011
N.B. These documents automatically identified may not have been verified by the study sponsor.