Status:
COMPLETED
Tiotropium/Salmeterol/Fluticasone Fixed Dose Combination Tratment Via Discair vs Tiotropium Via Handihaler + Salmeterol/Fluticasone Via Diskus Free Combination Treatment
Lead Sponsor:
Neutec Ar-Ge San ve Tic A.Ş
Conditions:
COPD
Eligibility:
All Genders
40-100 years
Phase:
PHASE4
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 m...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2020
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03395002
Start Date
March 22 2018
End Date
April 30 2020
Last Update
June 12 2020
Active Locations (2)
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1
Cukurova University Faculty of Medicine, Chest Diseases Department
Adana, Turkey (Türkiye)
2
Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)