Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neutec Ar-Ge San ve Tic A.Ş
• Treatments: Fluticasone; Salmeterol Xinafoate; Xhance

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