Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Asthma

• Registration Number: NCT03755544
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-28
• Study Start: 2019-01-16
• Status Verified: 2020-02
• Primary Completion: 2020-02-13
• Study Completion: 2020-02-13
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma Control Test (ACT)	12 weeks	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.
COPD Assessment Test (CAT)	12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
A questionnaire to assess Physician's/nurse's perception of Salmeterol/fluticasone Easyhaler overall use	12 weeks	A multiple-choice questionnaire for the physician/nurse, completed for each patient. Evaluation will be by frequency tables and summary statistics.
Health care utilisation questionnaire	24 weeks	A dichotomous questionnaire for all patients, there are 6 questions, with 'Yes' or 'No' answers, to collect health care use. Evaluation will be by frequency tables and summary statistics.
Forced vital capacity (FVC)	12 weeks	from spirometry
Feeling of Satisfaction with Inhaler questionnaire (FSI-10)	12 weeks	patient's satisfaction with inhaler
Asthma symptom control assessment	12 weeks	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.
Forced expiratory volume in one second (FEV1)	12 weeks	from spirometry
Mini-AQLQ questionnaire	12 weeks	A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-7. There are 15 questions to answer. The total score is calculated and ranges between 15 and 105. Lower scores indicate worse quality of life.
Modified Medical Research Council (mMRC) dyspnea questionnaire	12 weeks	A bipolar questionnaire for patients with COPD, there is one question with 5 choices between two extremes, respondents choose the answer that reflects their opinion (in the range 0-4).. Higher scores indicate worse dyspnea symptoms.
Symptom burden and exacerbation risk assessment (ABCD classification)	12 weeks	Patients will be assessed by the physician, based on symptoms and exacerbation history according to the ABCD classification scheme (GOLD, 2018).

Trial Locations

Locations (1)

Lungenpraxis; 🇩🇪 Hamburg, Germany