Trial Information
Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial
Inclusion Criteria:
- Patients were included if they reported breathlessness that had an impact on their
daily life and were suffering from one of the following conditions:
- Advanced malignant disease (primary lung cancer or secondary lung metastases/ lung
involvement due to cancer)
- COPD stage III (severe) and IV (very severe) according to GOLD criteria.[7]
Exclusion Criteria:
- Unable to provide informed consent
- Too ill to be interviewed and not fluent or illiterate in German
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
change of severity of breathlessness
Outcome Time Frame:
between baseline and one month
Safety Issue:
No
Principal Investigator
Claudia Bausewein, PhD MD MSc
Investigator Role:
Principal Investigator
Investigator Affiliation:
King's College London
Authority:
Germany: Ethics Commission
Study ID:
CREC 05/06-69
NCT ID:
NCT01123902
Start Date:
June 2006
Completion Date:
February 2008
Related Keywords:
- Primary Lung Cancer or Secondary Lung Metastases
- COPD III/IV
- Breathlessness
- Dyspnea
- Hand-held fan
- Palliative Care
- Dyspnea
- Lung Neoplasms
- Neoplasm Metastasis