ASSESSMENT OF THE EFFICACY OF THE HEDUSSIN® MEDICINAL PRODUCT USE IN THE TREATMENT OF PRODUCTIVE (WET) COUGH

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22945
• EU PAS number:
  EUPAS21094
• Study ID:
  22945
• Official title and acronym:
  ASSESSMENT OF THE EFFICACY OF THE HEDUSSIN® MEDICINAL PRODUCT USE IN THE TREATMENT OF PRODUCTIVE (WET) COUGH
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  The staff that will take part in the study consists of paediatricians, general practitioners, internists, allergists, pulmonologists or doctors currently in the process of obtaining these specializations who lead the treatment of patients (in the form of outpatient healthcare) suffering from productive cough of various aetiologies in which, due to clinical indications, the HEDUSSIN® medicinal product has been introduced. Data on the efficacy of the treatment with the HEDUSSIN® medicinal product will be gathered in the Study Questionnaires (SQ) during two subsequent routine visits: first (1), where the Patient will be included in the Study, and second (2) approximately 7-10 days after the first one. The visits will be scheduled in accordance with the needs resulting from the Patient’s clinical state. The inclusion of the Patient into the group where the given treatment method is used should not result from the Study Protocol. It should be dependent solely on the current medical practice and remain in accordance with the current medical knowledge. The medical history collection period, conducted by 50 investigators, is scheduled for 3 months.
• Study status:
  Finalised

Research institutions and networks

Institutions

Europharma

Study timelines

Date when funding contract was signed

Planned: 02/11/2016

Actual: 02/11/2016

Study start date

Planned: 01/12/2016

Actual: 01/12/2016

Data analysis start date

Planned: 31/03/2017

Actual: 31/03/2017

Date of interim report, if expected

Planned: 31/05/2017

Actual: 31/05/2017

Date of final study report

Planned: 15/10/2017

Actual: 27/09/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Phytopharm Klęka S.A.

Study protocol

Initial protocol

PAES HEDUSSIN PB ENG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable