Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD

NCT ID: NCT03755544

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-16

Study Completion Date

2020-02-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Orion Pharma Clinical Study Director

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Locations

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Lungenpraxis

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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3106013

Identifier Type: -

Identifier Source: org_study_id

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