Comparison of 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe COPD

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to compare the bronchodilator efficacy a of tiotropium inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

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

Details

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

Criteria

Inclusion Criteria:

• Patients aged 40 years and older with moderate to severe COPD diagnosis

• Current/former smokers with at least a 10 pack-year history of cigarette smoking

• Patients with established clinical COPD and severity defined as a post-broncodilator FEV1/FVC ratio of ≤0.70 and FEV1 ≤80 % of predicted normal at screening

• Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods

• Have no excacerbation within last 4 weeks

• Hava capability of communicate with investigator

• Accept to adapt the procedures of study protocol

• Signed and dated informed consent

Exclusion Criteria:

• History of hypersensitivity to anticholinergics

• Diagnosis of asthma

• History of alergic rinit and athopy

• Current or history of lung cancer

• Known symptomatic prostatic hypertrophy requiring drug therapy

• Known narrow-angle glaucoma requiring drug therapy

• Have experienced exacerbation of COPD or lower respiratory inflammatory disease requiring use of antibiotics, oral or parenteral corticosteroids (CS) within 4 weeks prior to screening visit and/or during run-in period

• Patients vaccinated with poored virüs vaccinate within 2 weeks prior to screening visit and/or during run-in period

• Patients with a recent history of myocardial infarction, acute ischemic cardiac disease or severe cardiac arrhythmia requiring drug therapy

• Women who are pregnant or lactating or are planning on becoming pregnant during the study