Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD (SUNNY)

Orion Pharma

Status: Completed

Conditions: Asthma; Chronic Obstructive Pulmonary Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03755544

3106013

Details and patient eligibility

About

A non-interventional study to assess the clinical effectiveness of Salmeterol/fluticasone Easyhaler to achieve and maintain asthma or COPD control.

Full description

A prospective, open-label, non-interventional, multicentre study in adult patients with asthma or COPD who are treated with Salmeterol/fluticasone Easyhaler. During the study the Salmeterol/fluticasone Easyhaler will be used according to the Summary of Product Characteristics. Clinical effectiveness of the treatment will be evaluated with change in asthma or COPD symptoms during 12 weeks treatment.

Enrollment: 231 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

1. Male or female patients with asthma or COPD who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the study
2. Age ≥18 years.
3. Written informed consent obtained.

Main Exclusion Criteria:

1. Pregnant or lactating female patients.
2. Participation in other clinical studies during the study.
3. Known hypersensitivity (allergy) to salmeterol, fluticasone propionate or the excipient lactose
4. Any significant medical disease or condition or other factor that might interfere with study assessments or study participation.

Trial design

231 participants in 2 patient groups

Asthma patients

Description:

Male or female patients with diagnosed asthma who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the beginning of the study, and for whom the decision has already been made to switch to Salmeterol/fluticasone Easyhaler. During the study, the Salmeterol/fluticasone Easyhaler will be used according to the local Summary of Product Characteristics (SmPC).

COPD patients

Description:

Male or female patients with diagnosed COPD who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the beginning of the study, and for whom the decision has already been made to switch to Salmeterol/fluticasone Easyhaler. During the study, the Salmeterol/fluticasone Easyhaler will be used according to the local Summary of Product Characteristics (SmPC).