Trial document




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  DRKS00012661

Trial Description

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Title

Safety and efficacy of the treatment with the beecura beehive air therapy system BCS-IH16

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Trial Acronym

swarm study

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URL of the Trial

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Brief Summary in Lay Language

For the Treatment of lung diseases such as Asthma bronchiale or COPD medication in the form of tablets or Inhalation therapy / metered-dose inhalers has shown to be effective. Additionally there are indications that the Inhalation of beehive air may improve the lung capacity. Up to now several Inhalation therapies have been conducted by apiculturists, who offer this Therapie as a Wellness Treatment. So far there is no scientific proof for the benefit of the beehive air therapy.
This study therefore is designed to show proof of the efficacy of the beehive air inhalation, measured by the improvement of the lung capacity. Furthermore the safety of the beecura beehive air therapy System BCS-HI16 will be verified. The patients will receive either inhalations with the beehive air or inhalations with a Placebo, air from an empty beehive with an extracted honeycomb.
Before study start the medical history of the Patient will be documented and a comprehensive physical examination, including a spirometry, will be done. Furthermore the patients will have to fill out a questionnaire on their Quality of life.
During the Course of the study the Patient will receive 10 inhalations with the beehive air or the Placebo on 10 consecutive days. After the 10th day another spirometry will be done and another questionnaire on life Quality has to be filled out by the Patient.
Potential subjects for this study are patients with Asthma bronchiale or COPD.


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Brief Summary in Scientific Language

Prospective, randomized, interventional study to determine efficacy and safety of the treatment of patients with COPD or Asthma bronchiale and a FEV1 of 50-80% with the beecura beehive therapy system BCS-IH16.
The efficacy is considered as verified when the FEV1 has improved by 6 % after the inhalation of the beehive air.
The safety will be measured by allergic reactions or dyspnoeas during or immediately after the Inhalation of the beehive air or deterioration of the FEV1 immediately after the beehive air Inhalation.
Patients will be randomized to either group A (beehive air) or group B (air of empty beehive with extracted honeycomb/placebo).

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012661
  •   2018/04/30
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  •   no
  •   Approved
  •   EK-MPG-MO-1/17-1, Ethikkommission bei der Sächsischen Landesärztekammer
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Secondary IDs

  •   CIV-17-06-020224 
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Health Condition or Problem studied

  •   J44 -  Other chronic obstructive pulmonary disease
  •   J45 -  Asthma
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Interventions/Observational Groups

  •   Patients with COPD or Asthma bronchiale and a FEV1 between 50 and 80%. Patients inhale beehive air using the beecura beehive air therapy system BCS-IH16 (10 daily therapy sessions over 10 days). Tests: physical examination (including spirometry) and questionnaires.
  •   Patients with COPD or Asthma bronchiale and a FEV1 between 50 and 80%. Patients inhale placebo (air from an empty beehive with an extracted honeycomb) using the beecura beehive air therapy system BCS-IH16 (10 daily therapy sessions over 10 days). Tests: physical examination (including spirometry) and questionnaires.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Treatment
  •   Parallel
  •   II-III
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2018/05/03
  •   30
  •   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

- 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

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Exclusion Criteria

- 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

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Addresses

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    • APIPRO Natura
    • Mr.  Jürgen  Schmiedgen 
    • Hauptstr. 13
    • 09474  Crottendorf OT Walthersdorf
    • Germany
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    • Praxis
    • Mr.  Dr. med.  Thomas  Huber 
    • Seminarstr. 41
    • 08289  Schneeberg
    • Germany
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    • Praxis
    • Mr.  Dr. med.  Thomas  Huber 
    • Seminarstr. 41
    • 08289  Schneeberg
    • Germany
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Sources of Monetary or Material Support

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    • APIPRO Natura
    • Mr.  Jürgen  Schmiedgen 
    • Hauptstr. 13
    • 09474  Crottendorf OT
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/05/16
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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.