Status:
TERMINATED
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD
Lead Sponsor:
Neutec Ar-Ge San ve Tic A.Ş
Conditions:
COPD
Eligibility:
All Genders
40-100 years
Phase:
PHASE4
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 D...
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 D...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03363503
Start Date
April 13 2018
End Date
April 13 2022
Last Update
May 20 2022
Active Locations (2)
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1
Akdeniz University Faculty of Medicine, Chest Diseases Department
Antalya, Turkey (Türkiye)
2
Republic of Turkey Ministry of Health Antalya Training and Research Hospital
Antalya, Turkey (Türkiye)