Back to resultsSalmeterol/Fluticasone 50/500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD (COPD)
Primary Purpose
COPD
Status
Terminated
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Salmeterol/Fluticasone Capsair®
Salmeterol/Fluticasone Diskus®
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, Salmeterol/Fluticasone, Discair, Diskus, Spirometry
Eligibility Criteria
Inclusion Criteria:
- Patients aged ≥40 years with moderate-severe COPD diagnosis according to the GOLD (The Global Initiative for Chronic Obstructive Lung Disease) strategy
- Patients who have symptomatic stable moderate to severe COPD diagnosis with post-bronchodilator FEV1/ Forced Vital Capacity (FVC) <0.70, and FEV1 ≥30% and <80% of predicted normal value at screening visit
- Current smokers or ex-smokers with a smoking history of at least 10 pack-years
- Patients who have no exacerbation within last 4 weeks
- Females patients with childbearing potential using effective birth control method
- Patients whose medication unchanged within least 4 weeks
- Patients who has a capability of communicate with investigator
- Patients who accept to comply with the requirements of the protocol
- Patients who signed written informed consent prior to participation
Exclusion Criteria:
- History of hypersensitivity to long acting beta-2 agonists or corticosteroids
- History of asthma or significant chronic respiratory diseases (e.g., interstitial lung diseases, significant bronchiectasis, etc.)
- Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to screening visit or during run-in period
- Use of immunosupresants or systemic corticosteroids within least 4 weeks
- History of severe cardiac arrhythmia or myocardial infarction within less than 6 months
- Significant or uncontrolled disease that may preclude participant from participating in the study
- Diognosis of cancer
- History of lung volume reduction operation
- Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period
- Women patients who are pregnant or nursing
- History of allergic rhinitis and atopy
Sites / Locations
- Akdeniz University Faculty of Medicine, Chest Diseases Department
- Republic of Turkey Ministry of Health Antalya Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Salmeterol/Fluticasone Capsair®
Salmeterol/Fluticasone Diskus®
Arm Description
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks
Outcomes
Primary Outcome Measures
Mean maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1)
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Mean percentage (%) change from baseline in
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Comparison of FEV1 values at pre-dose and 2 hours post-dose
Spirometric measurement will be performed at pre-dose and 2 hours post-dose
FEV1 (AUC0-12) response [AUC: area under the curve; response defined as change from baseline]
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FVC (AUC0-12) response
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FEV1 (AUC12-24) response
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FVC (AUC12-24) response
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FEV1 (AUC0-24) response
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
FVC (AUC0-24) response
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Secondary Outcome Measures
Mean change from baseline in transition dyspnea index (TDI) after 8-weeks treatment
Transition Dyspnea Index (TDI), a measure of the degree of breathlessness, captures changes from baseline. Baseline Dyspnea Index (BDI) score is based on three domains: functional impairment, magnitude of task and magnitude of effort. BDI will be measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best).
Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) after 8-weeks treatment
SGRQ is a 51-item health related quality of life questionnaire and it consists of three sections; Symptoms-measuring the frequency and severity of respiratory symptoms, Activity-measuring limitation of activities by breathlessness and activities that cause breathlessness and Impacts-measuring disturbances in social and psychological functioning due to airway disease. It will be performed to evaluate quality of life of the patients by comparing pre-treatment and post-treatment values. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Mean change from baseline in symptom severity and frequency (mean change from baseline in CAT score)
The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. It contains 8 questions regarding symptoms with scoring rage of zero to 40 (It will be completed using a 6 point scale).
Frequency of rescue medicine (salbutamol) used
Patients will use a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.
Time to onset of bronchodilator effect and maximum effect
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Adverse events, serious adverse events and all cause mortality.
Safety will be assessed through the vital signs, number of adverse events, serious adverse events and all cause mortality.
Full Information
NCT ID
NCT03363503
First Posted
November 17, 2017
Last Updated
May 16, 2022
Sponsor
Neutec Ar-Ge San ve Tic A.Ş
1. Study Identification
Unique Protocol Identification Number
NCT03363503
Brief Title
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD
Acronym
COPD
Official Title
Comparison of Efficacy and Safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Treatment Administered Via Capsair and Original Product Seretide Diskus 500 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Adequate number of patients could not be reached in the relevant centers.
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
April 13, 2022 (Actual)
Study Completion Date
April 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neutec Ar-Ge San ve Tic A.Ş
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the current study is to compare the efficacy and safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder treatment administered via Capsair twice daily and original product Seretide Diskus 500 mcg Inhalation Powder treatment twice daily in patients with moderate-severe COPD.
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits of 11-weeks study period.
Detailed Description
The aim of the current study is to compare the efficacy and safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder treatment administered via Capsair twice daily and original product Seretide Diskus 500 mcg Inhalation Powder treatment twice daily in patients with moderate-severe COPD.
Patients who met all the inclusion criteria will enter a 1-week run-in period with the length determine by the specific medication, during which their usual treatment will be stopped and they will receive salbutamol as required.
Following run-in period, patients will be randomly assigned to receive Salmeterol/Fluticasone 50/500 mcg as dry powder capsule for inhalation by Capsair or Salmeterol/Fluticasone 50/500 mcg as dry powder for inhalation by Diskus twice daily for 8-weeks treatment period.
Patients will be evaluated at 6 consecutive visits: baseline (enrollment), screening, treatment (treatment initiation, after 4 and 8 weeks of treatment) and after treatment (will carry out by telephone two weeks following the last dose of study medication).
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits of 11-weeks study period.
Safety will be assessed through vital signs, adverse events, serious adverse events and all cause mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
COPD, Salmeterol/Fluticasone, Discair, Diskus, Spirometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salmeterol/Fluticasone Capsair®
Arm Type
Experimental
Arm Description
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
Arm Title
Salmeterol/Fluticasone Diskus®
Arm Type
Active Comparator
Arm Description
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Salmeterol/Fluticasone Capsair®
Other Intervention Name(s)
Serair 50/500 mcg Capsair® Inhalation Powder
Intervention Description
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Salmeterol/Fluticasone Diskus®
Other Intervention Name(s)
Seretide Diskus® 500 mcg Inhalation Powder
Intervention Description
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks
Primary Outcome Measure Information:
Title
Mean maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1)
Description
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Time Frame
8-weeks treatment period after randomization
Title
Mean percentage (%) change from baseline in
Description
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Time Frame
8-weeks treatment period after randomization
Title
Comparison of FEV1 values at pre-dose and 2 hours post-dose
Description
Spirometric measurement will be performed at pre-dose and 2 hours post-dose
Time Frame
8-weeks treatment period after randomization
Title
FEV1 (AUC0-12) response [AUC: area under the curve; response defined as change from baseline]
Description
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Time Frame
8-weeks treatment period after randomization
Title
FVC (AUC0-12) response
Description
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Time Frame
8-weeks treatment period after randomization
Title
FEV1 (AUC12-24) response
Description
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Time Frame
8-weeks treatment period after randomization
Title
FVC (AUC12-24) response
Description
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Time Frame
8-weeks treatment period after randomization
Title
FEV1 (AUC0-24) response
Description
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Time Frame
8-weeks treatment period after randomization
Title
FVC (AUC0-24) response
Description
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Time Frame
8-weeks treatment period after randomization
Secondary Outcome Measure Information:
Title
Mean change from baseline in transition dyspnea index (TDI) after 8-weeks treatment
Description
Transition Dyspnea Index (TDI), a measure of the degree of breathlessness, captures changes from baseline. Baseline Dyspnea Index (BDI) score is based on three domains: functional impairment, magnitude of task and magnitude of effort. BDI will be measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best).
Time Frame
8-weeks treatment period after randomization
Title
Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) after 8-weeks treatment
Description
SGRQ is a 51-item health related quality of life questionnaire and it consists of three sections; Symptoms-measuring the frequency and severity of respiratory symptoms, Activity-measuring limitation of activities by breathlessness and activities that cause breathlessness and Impacts-measuring disturbances in social and psychological functioning due to airway disease. It will be performed to evaluate quality of life of the patients by comparing pre-treatment and post-treatment values. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Time Frame
8-weeks treatment period after randomization
Title
Mean change from baseline in symptom severity and frequency (mean change from baseline in CAT score)
Description
The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. It contains 8 questions regarding symptoms with scoring rage of zero to 40 (It will be completed using a 6 point scale).
Time Frame
8-weeks treatment period after randomization
Title
Frequency of rescue medicine (salbutamol) used
Description
Patients will use a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.
Time Frame
8-weeks treatment period after randomization
Title
Time to onset of bronchodilator effect and maximum effect
Description
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits.
Time Frame
8-weeks treatment period after randomization
Title
Adverse events, serious adverse events and all cause mortality.
Description
Safety will be assessed through the vital signs, number of adverse events, serious adverse events and all cause mortality.
Time Frame
10 weeks after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged ≥40 years with moderate-severe COPD diagnosis according to the GOLD (The Global Initiative for Chronic Obstructive Lung Disease) strategy
Patients who have symptomatic stable moderate to severe COPD diagnosis with post-bronchodilator FEV1/ Forced Vital Capacity (FVC) <0.70, and FEV1 ≥30% and <80% of predicted normal value at screening visit
Current smokers or ex-smokers with a smoking history of at least 10 pack-years
Patients who have no exacerbation within last 4 weeks
Females patients with childbearing potential using effective birth control method
Patients whose medication unchanged within least 4 weeks
Patients who has a capability of communicate with investigator
Patients who accept to comply with the requirements of the protocol
Patients who signed written informed consent prior to participation
Exclusion Criteria:
History of hypersensitivity to long acting beta-2 agonists or corticosteroids
History of asthma or significant chronic respiratory diseases (e.g., interstitial lung diseases, significant bronchiectasis, etc.)
Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to screening visit or during run-in period
Use of immunosupresants or systemic corticosteroids within least 4 weeks
History of severe cardiac arrhythmia or myocardial infarction within less than 6 months
Significant or uncontrolled disease that may preclude participant from participating in the study
Diognosis of cancer
History of lung volume reduction operation
Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period
Women patients who are pregnant or nursing
History of allergic rhinitis and atopy
Facility Information:
Facility Name
Akdeniz University Faculty of Medicine, Chest Diseases Department
City
Antalya
Country
Turkey
Facility Name
Republic of Turkey Ministry of Health Antalya Training and Research Hospital
City
Antalya
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD
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