A method to study the effect of bronchodilators on smoke retention in COPD patients: study protocol for a randomized controlled trial
2011

Study on Bronchodilators and Smoke Retention in COPD Patients

Sample size: 40 publication Evidence: moderate

Author Information

Author(s): Wouter van Dijk, Paul Scheepers, Robbert Cremers, Jacques Lenders, Chris van Weel, Tjard Schermer, Yvonne Heijdra

Primary Institution: Radboud University Nijmegen Medical Centre

Hypothesis

We hypothesised an interaction between bronchodilators and smoking that enhances smoke exposure, and hence cardiovascular disease.

Conclusion

The study aims to provide crucial new insights on the safety of prescribing bronchodilators to COPD patients who continue smoking.

Supporting Evidence

  • The pilot study revealed valid equations for inhaled tar and nicotine.
  • The study is registered at ClinicalTrials.gov.
  • Participants smoke cigarettes under controlled conditions.
  • The study protocol is approved by the local accredited medical review ethics committee.

Takeaway

This study is trying to find out if using bronchodilators while smoking makes COPD patients absorb more harmful smoke into their lungs.

Methodology

The study is designed as a double-blinded, placebo-controlled, randomised crossover trial.

Potential Biases

Selection bias is minimized by recruiting patients from a specific department and using strict inclusion criteria.

Limitations

The study is limited to COPD patients classified as GOLD stage II-III, which may affect generalizability.

Participant Demographics

Participants are current smokers with COPD, specifically GOLD stage II-III.

Statistical Information

P-Value

p < 0.01

Statistical Significance

p < 0.01

Digital Object Identifier (DOI)

10.1186/1745-6215-12-37

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