Skip to main content
OpenTrials
Completed

NCT Number: NCT03755544

Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lungenpraxis

Hamburg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • 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.

Main Exclusion Criteria:

  • 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.

Treatment and study plan

Primary outcomes

  1. Asthma Control Test (ACT)

    Time frame: 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.

  2. COPD Assessment Test (CAT)

    Time frame: 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 outcomes

  1. Asthma symptom control assessment

    Time frame: 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.

  2. Forced expiratory volume in one second (FEV1)

    Time frame: 12 weeks

    from spirometry

  3. Feeling of Satisfaction with Inhaler questionnaire (FSI-10)

    Time frame: 12 weeks

    patient's satisfaction with inhaler

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

    Time frame: 12 weeks

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

  5. Mini-AQLQ questionnaire

    Time frame: 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.

  6. Health care utilisation questionnaire

    Time frame: 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.

  7. Modified Medical Research Council (mMRC) dyspnea questionnaire

    Time frame: 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.

  8. Symptom burden and exacerbation risk assessment (ABCD classification)

    Time frame: 12 weeks

    Patients will be assessed by the physician, based on symptoms and exacerbation history according to the ABCD classification scheme (GOLD, 2018).

  9. Forced vital capacity (FVC)

    Time frame: 12 weeks

    from spirometry

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study 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

Acronym: SUNNY

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 28, 2018
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.