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Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD (SUNNY)

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ClinicalTrials.gov Identifier: NCT03755544
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Asthma Chronic Obstructive Pulmonary Disease

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.

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Study Type : Observational
Estimated Enrollment : 310 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
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).




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be enrolled by physicians from outpatient clinics
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755544


Contacts
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Contact: Orion Pharma Clinical Study Director +35810 426 6476 clinicaltrials@orionpharma.com

Locations
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Germany
Lungenpraxis Recruiting
Hamburg, Germany
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Study Director: Orion Pharma Clinical Study Director Orion Corporation, Orion Pharma

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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03755544     History of Changes
Other Study ID Numbers: 3106013
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Asthma
Anti-Asthmatic Agents
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action