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Tiotropium/Salmeterol/Fluticasone Fixed Dose Combination Tratment Via Discair vs Tiotropium Via Handihaler + Salmeterol/Fluticasone Via Diskus Free Combination Treatment

Sponsor
Neutec Ar-Ge San ve Tic A.Ş (Industry)
Overall Status
Completed
CT.gov ID
NCT03395002
Collaborator
(none)
58
Enrollment
2
Locations
2
Arms
25.3
Actual Duration (Months)
29
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall objective is to asses the bronchodilator effect of Tiotropium/Salmeterol/Fluticasone combination delivered via Discair® twice daily as compared with original products Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18 mcg Inhalation Powder once daily free combination treatment in patients with stable moderate to severe COPD.

Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder
  • Drug: Tiotropium 18 mcg Inhalation Powder
  • Drug: Salmeterol/Fluticasone 50/500 mcg Inhalation Powder
 Phase 4

Detailed Description

The overall objective is to asses the bronchodilator effect of Tiotropium/Salmeterol/Fluticasone combination delivered via Discair® twice daily as compared with original products Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18 mcg Inhalation Powder once daily free combination treatment in patients with stable moderate to severe COPD.

For formerly diagnosed patients who met all the inclusion criteria and receiving COPD treatment, the day of the screening visit will be based on the completion of a run-in period, with the length determined by the specific medication. During the run-in period, salbutamol (100 μg inhaler) will be prescribed as a rescue medication.

Patients (following run-in period for formerly diagnosed patients) will be randomly assigned to receive Tiotropium/Salmeterol/Fluticasone fixed dose combination as dry powder inhalation delivered via Discair® twice daily or Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18 mcg Inhalation Powder once daily free combination for 2-days treatment period.

Patients will be evaluated at 4 consecutive visits: baseline (enrollment), screening, treatment and after treatment.

Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Bronchodilator Efficacy of Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Combination Treatment Administered Via Discair® With Original Products Seretide Diskus 500 mcg Inhalation Powder Plus Spiriva 18 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date :
Mar 22, 2018
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tiotropium/Salmeterol/Fluticasone

Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Discair®

Drug: Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder
Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily via Discair® for two days.
Other Names:
  • Saltif 9/50/500 mcg Inhalation Powder

    		•
    Active Comparator: Tiotropium + Salmeterol/Fluticasone

    Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® + Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus®

    Drug: Tiotropium 18 mcg Inhalation Powder
    Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® for two days.
    Other Names:
  • Spiriva 18 mcg Inhalation Powder

    • Drug: Salmeterol/Fluticasone 50/500 mcg Inhalation Powder
    Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for two days
    Other Names:
  • Seretide Diskus® 500 mcg Inhalation Powder

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean max change (ml) from baseline in FEV1 over a period of 48 hrs. [48 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    2. Mean % change from baseline in FEV1 over a period of 48 hrs. [48 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    3. Mean max change (ml) from baseline in FVC over a period of 48 hrs. [48 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    4. Mean % change from baseline in FVC over a period of 48 hrs. [48 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    5. FEV1 (AUC0-12) response [AUC: area under the curve; response defined as change from baseline] [Day 1: 0-12 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    6. FVC (AUC0-12) response [Day 1: 0-12 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    7. FEV1 (AUC12-24) response [Day 1: 12-24 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    8. FVC (AUC12-24) response [Day 1: 12-24 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    9. FEV1 (AUC24-48) response [Day 2: 0-24 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    10. FVC (AUC24-48) response [Day 2: 0-24 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    11. FEV1 (AUC0-48) response [48 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    12. FVC (AUC0-48) response [48 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    Secondary Outcome Measures

    1. The time to onset of bronchodilator effect [48 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    2. The time to onset of maximum effect [48 hrs]

      Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment (pre-dose, 15. min, 30. min, 1. hr, 2. hr, 4.hr, 8.hr and 12.hr) during the first treatment day and at 16 different time points (15. min, 30. min, 1. hr, 2. hr, 4.hr, 6 hr, 8.hr and 12.hr) during the second treatment day.

    3. Evaluation of safety of study drug [48 hrs]

      Number of participants with treatment-related adverse events and/or abnormal laboratory values.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients aged ≥40 years with 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/FVC ratio <0.70, and FEV1 <80% of predicted normal value at screening visit.

    • Patients with a mMRC score ≥2

    • Current smokers or ex-smokers with a smoking history of at least 10 pack-years

    • Patients who have an exacerbation within least a year and no exacerbation within last 4 weeks

    • Females patients with childbearing potential using effective birth control method

    • 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 drugs contains long acting beta-2 agonists, corticosteroids, anticholinergics or lactose.

    • History of asthma or significant chronic respiratory diseases except COPD.

    • 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.

    • Patients with serum potassium level ≤ 3.5 mEq/L or >5.5 mEq/L

    • Patients who used systemic corticosteroids or immunosupresants within 4 weeks prior to study onset

    • Patients who have a history of myocardial infarction, hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks

    • Patients who have lung cancer

    • Patients who had lung volume reduction operation

    • Patients who had 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 or atopy

    • Known symptomatic prostatic hypertrophy requiring drug therapy or operation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cukurova University Faculty of Medicine, Chest Diseases Department Adana Turkey
    2 Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Neutec Ar-Ge San ve Tic A.Ş

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Neutec Ar-Ge San ve Tic A.Ş
    ClinicalTrials.gov Identifier:
    NCT03395002
    Other Study ID Numbers:
    • NEU-01.17
    First Posted:
    Jan 9, 2018
    Last Update Posted:
    Jun 12, 2020
    Last Verified:
    Jan 1, 2019
    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
    Tiotropium
    Salmeterol
    Fluticasone
    COPD
    Bronchodilator effect
    Discair
    Diskus
    Spirometry
    Additional relevant MeSH terms:
    Fluticasone
    Xhance
    Tiotropium Bromide
    Salmeterol Xinafoate

    Study Results

    No Results Posted as of Jun 12, 2020