Trial document




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  DRKS00015450

Trial Description

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Title

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

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Trial Acronym

RESPIRO

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URL of the Trial

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Brief Summary in Lay Language

Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death worldwide. The exact prevalence of COPD in the German population is not known, but available data indicate a prevalence of 13% in adults aged over 40 years. In Western countries, tobacco smoking represents the most important cause for the development of COPD and only tobacco abstinence has been proven to reduce the accelerated loss of lung function. According to clinical guidelines, advice on quitting tobacco and assistance to do so should be provided to all COPD patients. However, quitting tobacco is extremely difficult: less than 5% of unaided attempts succeed in the long term. Success rates can be increased substantially through use of methods which have proven to be effective, but evidence of these methods usually derives from rigorously controlled studies. Hence, generalizability of these data to the general patient population seen in routine care is limited. Observational "real-world" studies are important to supplement existing data. Particularly for COPD patients, for whom abstinence is even more difficult than for smokers without COPD, hardly any data from Germany is available on current use and effectiveness of evidence-based methods under real-world conditions. Moreover, little is known on the use and effectiveness of smoking cessation methods which have not yet been proven to be effective (e.g., acupuncture), and on the electric (e-)cigarette as a potential new aid for smoking cessation in patients with COPD.

The overall aim of this study is to provide detailed data on use and effectiveness of cessation methods in COPD patients in the "real-world".

We plan to collect data from a baseline sample of approximately 2,000 smokers and recent ex-smokers (<12 months abstinence) with COPD, representative for patients in pulmonary care, from about 25 pulmonary practices in the German federal state North Rhine-Westphalia.

The following data will be collected by means of baseline questionnaire and second postal questionnaire six months following baseline: respiratory symptoms, health-related quality of life, current smoking status, smoking and quitting behavior, methods used for a quit attempt (if so).

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Brief Summary in Scientific Language

Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death worldwide. The exact prevalence of COPD in the German population is not known, but available data indicate a prevalence of 13% in adults aged over 40 years. In Western countries, tobacco smoking represents the most important cause for the development of COPD and only tobacco abstinence has been proven to reduce the accelerated loss of lung function. According to clinical guidelines, advice on quitting tobacco and assistance to do so should be provided to all COPD patients. However, quitting tobacco is extremely difficult: less than 5% of unaided attempts succeed in the long term. Success rates can be increased substantially through use of evidence-based methods, but evidence of these methods usually derives from randomised controlled trials (RCTs). Hence, generalizability of these data to the general patient population seen in routine care is limited because of RCT selection criteria. Observational "real-world" studies are important to supplement RCT data. Particularly for COPD patients, who frequently suffer from anxio-depressive symptoms and strong nicotine dependency which make abstinence even more difficult for this group, hardly any data from Germany is available on current use and effectiveness of evidence-based methods under real-world conditions. Moreover, little is known on the use and effectiveness of non-evidence based smoking cessation methods (e.g., acupuncture) and on the electric (e-)cigarette as a potential new aid for smoking cessation in patients with COPD.

Within the proposed cross-sectional study, we aim to collect baseline questionnaire data of 2,000 smokers and recent ex-smokers (<12 months abstinence) with COPD from 25 pulmonary practices in the German federal state North Rhine-Westphalia. Baseline questions cover rates, success, and triggers of quit attempts, use of “harm reduction” strategies, and use of cessation methods, as well as respiratory symptoms and health-related quality of life. Primary analyses focus on use and effectiveness of evidence-based and non-evidence based cessation methods under real-world conditions. A six-month postal follow-up focuses on smoking status and on whether or not patients have made a quit attempt during the past six months. This prospective element enables us to further analyse the real-world effectiveness of smoking cessation methods using longitudinal data (secondary objective). Potential confounders will be considered (e.g., nicotine dependency, severity of COPD, anxio-depressive symptoms). Moreover, data will be compared with data from the general German smoking population (DEBRA study, DRKS00011322) which we are currently collecting.

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Organizational Data

  •   DRKS00015450
  •   2018/09/05
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  •   yes
  •   Approved
  •   5680R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   J44.8 -  Other specified chronic obstructive pulmonary disease
  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
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Interventions/Observational Groups

  •   Within the proposed cross-sectional study, we aim to collect baseline questionnaire data of 2,000 tobacco smokers and recent ex-smokers (<12 months abstinence) with COPD from 25 pulmonary practices in the German federal state North Rhine-Westphalia. Baseline questions cover rates, success, and triggers of quit attempts, use of “harm reduction” strategies, and use of cessation methods, as well as respiratory symptoms and health-related quality of life. Primary analyses focus on use and effectiveness of evidence-based and non-evidence based cessation methods under real-world conditions. A six-month postal follow-up focuses on smoking status and on whether or not patients have made a quit attempt during the past six months. This prospective element enables us to further analyse the real-world effectiveness of smoking cessation methods using longitudinal data (secondary objective). Potential confounders will be considered (e.g., nicotine dependency, severity of COPD, anxio-depressive symptoms). Moreover, data will be compared with data from the general German smoking population (DEBRA study, DRKS00011322) which we are currently collecting.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

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.
2) The real-world effectiveness of these smoking cessation methods with cross-sectional data, adjusted for potential confounders (in particular nicotine dependence).
These parameters will be collected by paper-and-pencil baseline questionnaire.

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Secondary Outcome

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.
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.
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).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2018/10/01
  •   2000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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Exclusion Criteria

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

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Addresses

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    • Medizinische Fakultät der Heinrich Heine Universität Düsseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Institut für Allgemeinmedizin (ifam) Medizinische Fakultät der Heinrich Heine Universität
    • Ms.  Dr.rer.nat.  Sabrina  Kastaun 
    • Werdenerstr. 4/ 101007
    • 40227  Düsseldorf
    • Germany
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    • Institut für Allgemeinmedizin (ifam) Medizinische Fakultät der Heinrich Heine Universität
    • Ms.  B.Sc.  Yekaterina  Pashutina 
    • Werdenerstr. 4/ 101007
    • 40225  Duesseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Research Commission of the Medical Faculty at the Heinrich-Heine-University Duesseldorf, Germany
    • Moorenstr. 5
    • 40225  Duesseldorf
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.