Tiotropium/Formoterol Via Discair® vs Tiotropium Monotherapy or Tiotropium + Formoterol Free Combination Treatment

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective is to asses the bronchodilator effect of once daily Tiotropium/Formoterol combination delivered via Discair® by comparing Tiotropium (q.d.) monotherapy delivered via Handihaler and tiotropium (q.d.) delivered via Handihaler + formoterol (b.i.d) delivered via Aerolizer free combination treatment in patients with stable moderate to severe COPD.

Spirometric measurements (FEV1, FVC) will be performed for a period of 24 h at 12 different times: pre-treatment (15 min prior to the first dose) and post-treatment (30. min, 60 min [1 hr], 120 min [2 hr], 180 min [3 hr], 240 min [4 hr], 360 min [6 hr], 480 min [8 hr], 600 min [10 hr], 720 min [12 hr], 840 min [14 hr],1440 min [24 hr].

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neutec Ar-Ge San ve Tic A.Ş
• Treatments: Formoterol Fumarate; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Patients aged ≥40 years with COPD diagnosis according to the current 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 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

• Female patients with childbearing potential using effective birth control method

• Patients who signed written informed consent prior to participation

• Patients who accept to comply with the requirements of the protocol

• Patients who have a capability of communicate with investigator

Exclusion Criteria:

• History of hypersensitivity to drugs contains anticholinergics, beta-adrenergic, lactose

• Diagnosis of asthma

• Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period.

• 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 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 with active tuberculosis

• Patients who use oxygen therapy

• Patients who have common interstitial lung diseases like cystic fibrosis, bronchiolitis obliterans

• Patients with serious liver or renal disease that leads to organ failure

• Women who are pregnant or nursing

• History of allergic rhinitis and atopy

• Known symptomatic prostatic hypertrophy requiring drug therapy or operation

• Patients with narrow-angle glaucoma requiring drug therapy