Dataset Information

Randomised placebo-controlled study of the effect of paracetamol on asthma severity in adults.

ABSTRACT:

Objective

To investigate the effect of regular paracetamol on bronchial hyper-responsiveness (BHR) and asthma control in adult asthma.

Setting

Single research-based outpatient clinic.

Participants

94 adults with mild-to-moderate asthma received randomised treatment; 85 completed the study. Key inclusion criteria were age 18-65 years, forced expiratory volume in 1 s (FEV1) >70% predicted, provocation concentration of methacholine causing a 20% reduction in FEV1 (PC20) between 0.125 and 16 mg/mL. Key exclusion criteria included an asthma exacerbation within the previous 2 months, current regular use of paracetamol, use of high-dose aspirin or non-steroidal anti-inflammatory drugs, current or past cigarette smoking >10 pack-years.

Interventions

In a 12-week randomised, double-blind, placebo-controlled, parallel-group study, participants received 12 weeks of 1 g paracetamol twice daily or placebo twice daily.

Primary and secondary outcome measures

The primary outcome variable was BHR, measured as the PC20 at week 12. Secondary outcome variables included FEV1, fractional exhaled nitric oxide (FeNO) and asthma control questionnaire (ACQ) score.

Results

At 12 weeks, the mean (SD) logarithm base two PC20 was 1.07 (2.36) in the control group (N=54) and 0.62 (2.09) in the paracetamol group (N=31). After controlling for baseline PC20, the mean difference (paracetamol minus placebo) was -0.48 doubling dose worsening in BHR in the paracetamol group (95% CI -1.28 to 0.32), p=0.24. There were no statistically significant differences (paracetamol minus placebo) in log FeNO (0.09 (95% CI -0.097 to 0.27)), FEV1 (-0.07 L (95% CI -0.15 to 0.01)) or ACQ score (-0.04 (95% CI -0.27 to 0.18)).

Conclusions

There was no significant effect of paracetamol on BHR and asthma control in adults with mild-to-moderate asthma. However, the study findings are limited by low power and the upper confidence limits did not rule out clinically relevant adverse effects.

Trial registration

Australia New Zealand Clinical Trials Registry Number: NZCTR12609000551291.

SUBMITTER: Ioannides SJ

PROVIDER: S-EPMC3927716 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Publications

Randomised placebo-controlled study of the effect of paracetamol on asthma severity in adults.

Ioannides Sally J SJ Williams Mathew M Jefferies Sarah S Perrin Kyle K Weatherall Mark M Siebers Robert R Crane Julian J Patel Mitesh M Travers Justin J Shirtcliffe Philippa P Beasley Richard R

BMJ open 20140212 2

<h4>Objective</h4>To investigate the effect of regular paracetamol on bronchial hyper-responsiveness (BHR) and asthma control in adult asthma.<h4>Setting</h4>Single research-based outpatient clinic.<h4>Participants</h4>94 adults with mild-to-moderate asthma received randomised treatment; 85 completed the study. Key inclusion criteria were age 18-65 years, forced expiratory volume in 1 s (FEV1) >70% predicted, provocation concentration of methacholine causing a 20% reduction in FEV1 (PC20) betwee ...[more]

PMID: 24525393

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Dataset Information

Randomised placebo-controlled study of the effect of paracetamol on asthma severity in adults.

Objective

Setting

Participants

Interventions

Primary and secondary outcome measures

Results

Conclusions

Trial registration

Publications

Randomised placebo-controlled study of the effect of paracetamol on asthma severity in adults.

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