Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD

Asthma Clinical Trial

— SUNNY  

Official title:

Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD; a Non-interventional Switch Study to Evaluate the Impact on Clinical Effects, Patient's Satisfaction, Preference and Use of Easyhaler

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755544
• Other study ID #: 3106013
• Status: Completed
• Start date: January 16, 2019
• Est. completion date: February 13, 2020

Study information

• Verified date: February 2020
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: February 13, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Germany	Lungenpraxis	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	Forced expiratory volume in one second (FEV1)	from spirometry	12 weeks
Secondary	Feeling of Satisfaction with Inhaler questionnaire (FSI-10)	patient's satisfaction with inhaler	12 weeks
Secondary	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.	12 weeks
Secondary	Mini-AQLQ questionnaire	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.	12 weeks
Secondary	Health care utilisation questionnaire	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.	24 weeks
Secondary	Modified Medical Research Council (mMRC) dyspnea questionnaire	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.	12 weeks
Secondary	Symptom burden and exacerbation risk assessment (ABCD classification)	Patients will be assessed by the physician, based on symptoms and exacerbation history according to the ABCD classification scheme (GOLD, 2018).	12 weeks
Secondary	Forced vital capacity (FVC)	from spirometry	12 weeks