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

Launched by NEUTEC AR-GE SAN VE TIC A.Ş · Dec 5, 2017

Keywords

ClinConnect 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.

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 Sa...

Gender

ALL

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