COPD
Conditions
Keywords
FEV1, FVC, AUC 0-24, bronchodilator efficacy, tiotropium
Brief 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).
Interventions
tiotropium 18 mcg once a day
Sponsors
Neutec Ar-Ge San ve Tic A.Ş
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) | prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose |
| Percantage (%) change from baseline in FEV1 and FVC | prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose |
| Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours -Post-dose | Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose |
| - Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response | Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset of bronchodilator effect and maximum effect | 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose |
| Adverse Events | predose and up to 24 hours postdose |
Outcome results
None listed