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Trial record 14 of 318 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT03395002
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Neutec Ar-Ge San ve Tic A.Ş

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
COPD 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 22, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019


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 Name: 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 Name: 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 Name: Seretide Diskus® 500 mcg Inhalation Powder




Primary Outcome Measures :
  1. Mean max change (ml) from baseline in FEV1 over a period of 48 hrs. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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] [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 48 hrs ]
    Number of participants with treatment-related adverse events and/or abnormal laboratory values.



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.


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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 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

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): NCT03395002


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

Locations
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Turkey
Cukurova University Faculty of Medicine, Chest Diseases Department Recruiting
Adana, Turkey
Contact: Ismail Hanta, Professor Doctor       ismailhnt@gmail.com   
Principal Investigator: Ismail Hanta         
Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: Hakan Gunen, Professor Doctor       hgunen@yahoo.com   
Principal Investigator: Hakan Gunen         
Sponsors and Collaborators
Neutec Ar-Ge San ve Tic A.Ş

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Responsible Party: Neutec Ar-Ge San ve Tic A.Ş
ClinicalTrials.gov Identifier: NCT03395002     History of Changes
Other Study ID Numbers: NEU-01.17
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019

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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:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Tiotropium Bromide
Bronchodilator Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics