Observational Program to Study Prescribing Practices of Montelast, 10 mg Film-coated Tablets (manufactured by Actavis Ltd., Malta for Actavis Group PTC ehf., Iceland) For Treatment of Bronchial Asthma and Allergic Rhinitis

Study identification

• EU PAS number:
  EUPAS13107
• Study ID:
  13108
• Official title and acronym:
  Observational Program to Study Prescribing Practices of Montelast, 10 mg Film-coated Tablets (manufactured by Actavis Ltd., Malta for Actavis Group PTC ehf., Iceland) For Treatment of Bronchial Asthma and Allergic Rhinitis
• DARWIN EU® study:
  No
• Study countries:
  Russian Federation
• Study description:
  The program is a prospective, observational clinical epidemiological study. Acting outpatient department allergologists and pulmonologists are planned to participate in the program. Doctors’ participation is voluntary. No specific procedures different of those used in routine practice are planned (except for data collected in accordance with CRF, to be collected for every subject enrolled). Data collection will be performed at baseline and after treatment completion, but not later than 12 weeks of study. All the procedures and visits schedule are determined by routine clinical practice and are not in any way specified by the protocol. When included into the program, demographic data will be collected, as well as clinical disease manifestations, underlying disease and its treatment, and prescribed treatment with Montelast.
• Study status:
  Finalised

Research institutions and networks

Institutions

Actavis

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:25/03/2015

Actual:25/03/2015

Study start date

Planned:01/05/2015

Actual:08/07/2015

Date of final study report

Planned:20/12/2015

Actual:15/02/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

LLC Actavis

Regulatory

• Was the study required by a regulatory body?:
  No