Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000729022
Ethics application status
Approved
Date submitted
31/08/2010
Date registered
1/09/2010
Date last updated
15/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of regular paracetamol use on the airways in asthma.
Scientific title
A randomised, double blind, parallel group, placebo-controlled trial of paracetamol on airways resistance in asthma.
Secondary ID [1] 252597 0
Nil
Universal Trial Number (UTN)
U1111-1116-6276
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 258094 0
Condition category
Condition code
Respiratory 258274 258274 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects randomised to the treatment group will take paracetamol 1g (2 x 500mg tablets) four times per day for 14 days.
Intervention code [1] 257120 0
Treatment: Drugs
Comparator / control treatment
Subjects randomised to the control group will take 2 x placebo tablets (dummy pills made primarily from calcium hydrogen phosphate and cellulose microcrystalline, to match 500gm paracetamol tablets in appearance) four times per day for 14 days
Control group
Placebo

Outcomes
Primary outcome [1] 259117 0
Airways resistance at 5Hz measured using an impulse oscillometry system (IOS)
Timepoint [1] 259117 0
14 days after commencement of treatment.
Primary outcome [2] 259118 0
Airways resistance at 20Hz measured using an impulse oscillometry system (IOS)
Timepoint [2] 259118 0
14 days after commencement of treatment.
Secondary outcome [1] 265429 0
Forced expiratory volume in one second (FEV1) using spirometry.
Timepoint [1] 265429 0
14 days after commencement of treatment.
Secondary outcome [2] 265432 0
Peripheral airways resistance (R5-20Hz) using an impulse oscillometry system (IOS).
Timepoint [2] 265432 0
14 days after commencement of treatment.
Secondary outcome [3] 266502 0
Markers of oxidative stress and prostaglandin metabolism present in the urine measured by enzyme immunoassay and mass spectrometry.
Timepoint [3] 266502 0
Baseline and 14 days after commencement of treatment.
Secondary outcome [4] 265430 0
Fraction of exhaled nitric oxide (FeNO) using an exhaled nitric oxide gas analyser.
Timepoint [4] 265430 0
14 days after commencement of treatment.
Secondary outcome [5] 265431 0
Airways reactance at 5Hz (X5) using an impulse oscillometry system (IOS).
Timepoint [5] 265431 0
14 days after commencement of treatment.

Eligibility
Key inclusion criteria
1. A doctor’s diagnosis of asthma plus wheeze in the previous 12 months and asthma inhaler use in the previous 12 months
2.18 – 65 years old
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients currently taking a long acting beta agonist (LABA), tiotropium or theophylline.
2.An exacerbation of asthma within the previous 6 weeks requiring prednisone, or nebulised bronchodilator.
3.Current or past cigarette smoking > 10 pack years.
4.History of allergy, sensitivity, potential significant drug interaction or other contra-indication to paracetamol
5.History of liver disease
6.Patients with a current history of regular use of paracetamol, who are unwilling or unable to discontinue use of this medication during the trial period.
7.Previous suicide attempt or current depression score of > 13 on the Hamilton Depression Rating Score (HDRS).
8.Body Mass Index (BMI) < 16.0 kg/m2.
9.Pregnant or breast-feeding women and women of child-bearing age not using adequate contraception.
10.Unable to perform or master techniques of pulmonary function testing.
11.Any other safety concern at the investigator’s discretion.

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)
Potential subjects will be sourced primarily from the research database, and from advertising if required. The study researcher will initially discuss the nature of the study over the phone with the subject and review eligibility criteria. If interested an information sheet will be sent for review. An appointment will be made at the clinic, where the study investigator will obtain informed consent and further determine their eligibility. At this appointment subjects will be randomised to active or placebo treatment.
The attending researchers will be blinded to the randomisation schedule, and only nominated members of the study team (for example the safety data reviewers) will have access to the schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done by a senior doctor on the research team once they have received from a statistician a randomisation table generated by statistical computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2844 0
New Zealand
State/province [1] 2844 0

Funding & Sponsors
Funding source category [1] 257563 0
Government body
Name [1] 257563 0
The Health Research Council of New Zealand (HRC)
Country [1] 257563 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Level G, CSB Building, Wellington Hospital
Riddiford Street, Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 256787 0
None
Name [1] 256787 0
Address [1] 256787 0
Country [1] 256787 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259585 0
Multi Region Ethics Committee
Ethics committee address [1] 259585 0
Ethics committee country [1] 259585 0
New Zealand
Date submitted for ethics approval [1] 259585 0
09/08/2010
Approval date [1] 259585 0
30/08/2010
Ethics approval number [1] 259585 0
MEC/10/06/050

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

Contacts
Principal investigator
Name 31589 0
Address 31589 0
Country 31589 0
Phone 31589 0
Fax 31589 0
Email 31589 0
Contact person for public queries
Name 14836 0
Richard Beasley
Address 14836 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 14836 0
New Zealand
Phone 14836 0
+64-4-8050147
Fax 14836 0
+64-4-3895707
Email 14836 0
richard.beasley@mrinz.ac.nz
Contact person for scientific queries
Name 5764 0
Richard Beasley
Address 5764 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 5764 0
New Zealand
Phone 5764 0
+64-4-8050147
Fax 5764 0
+64-4-3895707
Email 5764 0
richard.beasley@mrinz.ac.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
No additional documents have been identified.