A Phase 4 interventional study of Salmeterol/Fluticasone Capsair® and Salmeterol/Fluticasone Diskus® in COPD, sponsored by Neutec Ar-Ge San ve Tic A.Ş. Terminated at 2 sites in Turkey. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by Neutec Ar-Ge San ve Tic A.Ş · Phase 4, Interventional, and Treatment
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.
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 64 is close to the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Neutec Ar-Ge San ve Tic A.Ş is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
Drug: Salmeterol/Fluticasone Capsair®
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks
Drug: Salmeterol/Fluticasone Diskus®
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
Also known as: Serair 50/500 mcg Capsair® Inhalation Powder
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks
Also known as: Seretide Diskus® 500 mcg Inhalation Powder
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.
Time frame: 8-weeks treatment period after randomization
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.
Time frame: 8-weeks treatment period after randomization
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
Time frame: 8-weeks treatment period after randomization
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.
Time frame: 8-weeks treatment period after randomization
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.
Time frame: 8-weeks treatment period after randomization
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.
Time frame: 8-weeks treatment period after randomization
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.
Time frame: 8-weeks treatment period after randomization
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.
Time frame: 8-weeks treatment period after randomization
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.
Time frame: 8-weeks treatment period after randomization
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).
Time frame: 8-weeks treatment period after randomization
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.
Time frame: 8-weeks treatment period after randomization
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).
Time frame: 8-weeks treatment period after randomization
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 frame: 8-weeks treatment period after randomization
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.
Time frame: 8-weeks treatment period after randomization
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.
Time frame: 10 weeks after randomization
This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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