Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD

NCT03755544 | Completed

• 1 other identifier: 3106013
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (9)

• Asthma symptom control assessment

  12 weeks

• Forced expiratory volume in one second (FEV1)

  12 weeks

• Feeling of Satisfaction with Inhaler questionnaire (FSI-10)

  12 weeks

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

  12 weeks

• Mini-AQLQ questionnaire

  12 weeks

Study Arms (2)

Asthma patients

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

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).

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be enrolled by physicians from outpatient clinics

You may qualify if:

• 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
• Age ≥18 years.
• Written informed consent obtained.

You may not qualify if:

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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Lungenpraxis

Hamburg, Germany

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Orion Pharma Clinical Study Director

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 28, 2018
• Study Start: January 16, 2019
• Primary Completion: February 13, 2020
• Study Completion: February 13, 2020
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

DE (1)