Safety and efficacy of the treatment with the beecura beehive air therapy system BCS-IH16
- Conditions
- J44J45Other chronic obstructive pulmonary diseaseAsthma
- Registration Number
- DRKS00012661
- Lead Sponsor
- APIPRO Natura
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
patients must be capable to fill out an questionnaire on their quality of life
- patients with a COPD or Asthma bronchiale and FEV1 between 50 % and 80 %
- stable pulmonary medication without any changes in the last seven days
- written informed consent
- acute exacerbation of the pulmonary disease
- allergy against bee or wasp stings
- restrictive lung disorders
- malignant disease which is not yet cured
- diseases with a life expectancy less than 6 months
- heart insufficiency with an ejection fraction of less than 40 %
- imprisoned individuals or mental immature adults
- pregnant or breastfeeding patients
- women of child bearing potential not using contraception
- drug and alcohol abuse
- patients not capable of giving consent
- severe cognitive deficits or dementia
- participation in other clinical studies
- persons who may be dependet on the sponsor or investigator
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy, measured by FEV1 (%). The efficacy is considered as verified when the FEV1 has improved by 6 % after the inhalation of the beehive air. Measuring time points: before study start and after beehive air therapy. The efficacy will be measured by a questionnaire (SF-36) and evaluation by the patient.
- Secondary Outcome Measures
Name Time Method Safety, measured by: 1) occurences of allergic reactions or anaphylactic shock during or immediately after inhalation of the beehive air 2) dyspnoea during the inhalation of the beehive air or deterioration of FEV1 immediately after the beehive air inhalation.