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

Neutec Ar-Ge San ve Tic

Status and phase

Terminated

Phase 4

Conditions

COPD

Treatments

Drug: Salmeterol/Fluticasone Capsair®

Drug: Salmeterol/Fluticasone Diskus®

Study type

Interventional

Funder types

Industry

Identifiers

NCT03363503

NEU-11.15

Details and patient eligibility

About

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.

Full description

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).

Safety will be assessed through vital signs, adverse events, serious adverse events and all cause mortality.

Enrollment

64 patients

Sex

All

Ages

40 to 100 years old

Volunteers

No Healthy Volunteers

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