se and real-world effectiveness of smoking cessation methods in patients with chronic obstructive pulmonary disease (RESPIRO)

• Conditions: J44.8; J44.9; F17.2; Other specified chronic obstructive pulmonary disease; Chronic obstructive pulmonary disease, unspecified

• Registration Number: DRKS00015450
• Lead Sponsor: Medizinische Fakultät der Heinrich Heine Universität Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-05
• Study Completion: 2020-05-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2010

Inclusion Criteria

Current tobacco smokers (daily or occasionally) or recent ex-smoker (<12 months) with confirmed diagnosis of COPD:
a. J44.8 Other specified chronic obstructive pulmonary disease, including chronic bronchitis: asthmatic (obstructive) – emphysematous – obstructive,
b. J44.9 Chronic obstructive pulmonary disease, unspecified

Exclusion Criteria

1) Other severe or chronic pulmonary diagnosis, e.g. tuberculosis or bronchial carcinoma;
2) Moderate or severe cognitive impairment or low literacy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Prevalence rates of use of evidence-based (e.g., nicotine replacement therapy, bupropion, varenicline, behavioural support) and non-evidence based (e.g. hypnosis, acupuncture, e-cigarettes) smoking cessation methods in COPD patients during their most recent quit attempt.<br>2) The real-world effectiveness of these smoking cessation methods with cross-sectional data, adjusted for potential confounders (in particular nicotine dependence).<br>These parameters will be collected by paper-and-pencil baseline questionnaire.

Secondary Outcome Measures

Name	Time	Method
1) The real-world effectiveness of smoking cessation methods with longitudinal data (6-month follow-up). These parameters will be collected by paper-and-pencil follow-up survey.<br>2) Prevalence rates of the use of so-called harm reduction strategies (such as cutting down), rates (and duration) of smoking cessation attempts, external and internal triggers of these attempts. These parameters will be collected by paper-and-pencil baseline questionnaire together with the primary endpoints.<br>3) Differences in key performance indicators of smoking cessation between smokers with COPD and the general smoking population of Germany (comparison of primary and secondary outcomes of RESPIRO with data from our ongoing DEBRA study (German Study on Tobacco Use), DRKS00011322). <br>