ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03363503
Recruitment Status : Not yet recruiting
First Posted : December 6, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Neutec Ar-Ge San ve Tic A.Ş

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 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.


Condition or disease Intervention/treatment Phase
COPD Drug: Salmeterol/Fluticasone Capsair® Drug: Salmeterol/Fluticasone Diskus® Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 Capsair®
Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
Other Name: Serair 50/500 mcg Capsair® Inhalation Powder

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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 Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363503


Contacts
Contact: Neutec R&D +90 850 201 51 00 esrakorkmaz@neutecrdc.com

Locations
Turkey
Akdeniz University Faculty of Medicine, Chest Diseases Department Not yet recruiting
Antalya, Turkey
Contact: Aykut Cilli, Professor Doctor         
Contact       acilli@akdeniz.edu.tr   
Principal Investigator: Aykut Cilli, Professor Doctor         
Republic of Turkey Ministry of Health Antalya Training and Research Hospital Not yet recruiting
Antalya, Turkey
Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş

Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
ClinicalTrials.gov Identifier: NCT03363503     History of Changes
Other Study ID Numbers: NEU-11.15
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Neutec Ar-Ge San ve Tic A.Ş:
COPD
Salmeterol/Fluticasone
Discair
Diskus
Spirometry

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics