Tiotropium/Salmeterol/Fluticasone Fixed Dose Combination Tratment Via Discair vs Tiotropium Via Handihaler + Salmeterol/Fluticasone Via Diskus Free Combination Treatment
NCT ID: NCT03395002
Last Updated: 2020-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
58 participants
INTERVENTIONAL
2018-03-22
2020-04-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tiotropium/Salmeterol/Fluticasone
Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Discair®
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.
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®
Tiotropium 18 mcg Inhalation Powder
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® for two days.
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
Interventions
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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.
Tiotropium 18 mcg Inhalation Powder
Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® for two days.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
100 Years
ALL
No
Sponsors
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Neutec Ar-Ge San ve Tic A.Ş
INDUSTRY
Responsible Party
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Locations
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Cukurova University Faculty of Medicine, Chest Diseases Department
Adana, , Turkey (Türkiye)
Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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NEU-01.17
Identifier Type: -
Identifier Source: org_study_id
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