Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD

Orion Corporation, Orion Pharma231 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

231

Conditions

Asthma Chronic Obstructive Pulmonary Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Lungenpraxis

Hamburg, Germany

Outcomes

Primary Outcomes

Asthma Control Test (ACT)

A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-5. There are 5 questions to answer. The total score is calculated, ranging between 5 and 25. Lower scores indicate worse asthma control.

Time frame: 12 weeks

COPD Assessment Test (CAT)

A bipolar questionnaire for patients with COPD, there are 8 questions with 2 answers showing different extremes, respondents choose the numbered answer that reflects their opinion (in the range 0-5). The total score is calculated and ranges between 0 and 40. Higher scores indicate worse COPD control.

Time frame: 12 weeks

Secondary Outcomes

Asthma symptom control assessment

A dichotomous questionnaire for patients with asthma, there are 4 questions with 'Yes' or 'No' answers, respondents choose the answer that reflects their opinion. A great number of 'Yes' answers indicate worse asthma control.

Time frame: 12 weeks

Forced expiratory volume in one second (FEV1)

from spirometry

Time frame: 12 weeks

Feeling of Satisfaction with Inhaler questionnaire (FSI-10)

patient's satisfaction with inhaler

Time frame: 12 weeks

A questionnaire to assess Physician's/nurse's perception of Salmeterol/fluticasone Easyhaler overall use

A multiple-choice questionnaire for the physician/nurse, completed for each patient. Evaluation will be by frequency tables and summary statistics.

Time frame: 12 weeks

Mini-AQLQ questionnaire

Data from ClinicalTrials.gov

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