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

NCT03363503 | Terminated Phase 4

• 1 other identifier: NEU-11.15
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

COPD

Keywords

COPD; Salmeterol/Fluticasone; Discair; Diskus; Spirometry

Outcome Measures

Primary Outcomes (9)

• Mean maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1)

  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-weeks treatment period after randomization

• Mean percentage (%) change from baseline in

  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-weeks treatment period after randomization

• Comparison of FEV1 values at pre-dose and 2 hours post-dose

  Spirometric measurement will be performed at pre-dose and 2 hours post-dose

  8-weeks treatment period after randomization

• FEV1 (AUC0-12) response [AUC: area under the curve; response defined as change from baseline]

  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-weeks treatment period after randomization

• FVC (AUC0-12) response

  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-weeks treatment period after randomization

• FEV1 (AUC12-24) response

  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-weeks treatment period after randomization

• FVC (AUC12-24) response

  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-weeks treatment period after randomization

• FEV1 (AUC0-24) response

  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-weeks treatment period after randomization

• FVC (AUC0-24) response

  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-weeks treatment period after randomization

Secondary Outcomes (6)

• Mean change from baseline in transition dyspnea index (TDI) after 8-weeks treatment

  8-weeks treatment period after randomization

• Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) after 8-weeks treatment

  8-weeks treatment period after randomization

• Mean change from baseline in symptom severity and frequency (mean change from baseline in CAT score)

  8-weeks treatment period after randomization

• Frequency of rescue medicine (salbutamol) used

  8-weeks treatment period after randomization

• Time to onset of bronchodilator effect and maximum effect

  8-weeks treatment period after randomization

Study Arms (2)

Salmeterol/Fluticasone Capsair®

EXPERIMENTAL

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 Diskus®

ACTIVE COMPARATOR

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

Drug: Salmeterol/Fluticasone Diskus®

Interventions

Salmeterol/Fluticasone Capsair® DRUG

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

Also known as: Serair 50/500 mcg Capsair® Inhalation Powder

Salmeterol/Fluticasone Capsair®

Salmeterol/Fluticasone Diskus® DRUG

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

Also known as: Seretide Diskus® 500 mcg Inhalation Powder

Salmeterol/Fluticasone Diskus®

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

Study Sites (2)

Akdeniz University Faculty of Medicine, Chest Diseases Department

Antalya, Turkey (Türkiye)

Location

Republic of Turkey Ministry of Health Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: December 6, 2017
• Study Start: April 13, 2018
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

TU (2)