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

Overview

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 Title of Study: “Comparison of Efficacy and Safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Treatment Administered Via Capsair and Original Product Seretide Diskus 500 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease (COPD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 13, 2022

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 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.

Interventions

  • Drug: Salmeterol/Fluticasone Capsair®
    • Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
  • Drug: Salmeterol/Fluticasone Diskus®
    • Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks

Arms, Groups and Cohorts

  • Experimental: Salmeterol/Fluticasone Capsair®
    • Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
  • Active Comparator: Salmeterol/Fluticasone Diskus®
    • Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Mean maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1)
    • Time Frame: 8-weeks treatment period after randomization
    • 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.
  • Mean percentage (%) change from baseline in
    • Time Frame: 8-weeks treatment period after randomization
    • 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.
  • Comparison of FEV1 values at pre-dose and 2 hours post-dose
    • Time Frame: 8-weeks treatment period after randomization
    • Spirometric measurement will be performed at pre-dose and 2 hours post-dose
  • FEV1 (AUC0-12) response [AUC: area under the curve; response defined as change from baseline]
    • Time Frame: 8-weeks treatment period after randomization
    • 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.
  • FVC (AUC0-12) response
    • Time Frame: 8-weeks treatment period after randomization
    • 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.
  • FEV1 (AUC12-24) response
    • Time Frame: 8-weeks treatment period after randomization
    • 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.
  • FVC (AUC12-24) response
    • Time Frame: 8-weeks treatment period after randomization
    • 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.
  • FEV1 (AUC0-24) response
    • Time Frame: 8-weeks treatment period after randomization
    • 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.
  • FVC (AUC0-24) response
    • Time Frame: 8-weeks treatment period after randomization
    • 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.

Secondary Measures

  • Mean change from baseline in transition dyspnea index (TDI) after 8-weeks treatment
    • Time Frame: 8-weeks treatment period after randomization
    • 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).
  • Mean change from baseline in St. George’s Respiratory Questionnaire (SGRQ) after 8-weeks treatment
    • Time Frame: 8-weeks treatment period after randomization
    • 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.
  • Mean change from baseline in symptom severity and frequency (mean change from baseline in CAT score)
    • Time Frame: 8-weeks treatment period after randomization
    • 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).
  • Frequency of rescue medicine (salbutamol) used
    • Time Frame: 8-weeks treatment period after randomization
    • Patients will use a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms.
  • Time to onset of bronchodilator effect and maximum effect
    • Time Frame: 8-weeks treatment period after randomization
    • 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.
  • Adverse events, serious adverse events and all cause mortality.
    • Time Frame: 10 weeks after randomization
    • Safety will be assessed through the vital signs, number of adverse events, serious adverse events and all cause mortality.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Neutec Ar-Ge San ve Tic A.Ş
  • Provider of Information About this Clinical Study
    • Sponsor

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