Clinical trial NCT02541006: 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
Official title: A Randomized, Parallel-group, Phase IV Study to Compare the Bronchodilator Efficacy of Tiotropium (18 µg Once Daily [od]) Delivered Via a DISCAIR With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: FEV1
FVC
AUC 0-24
bronchodilator efficacy
tiotropium
Lead sponsor: Neutec Ar-Ge San ve Tic A.Ş
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Median maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
timeFrame: 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
measure: Percantage (%) change from baseline in FEV1 and FVC
timeFrame: 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
measure: Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours -Post-dose
timeFrame: 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
measure: - Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response
timeFrame: 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 outcomes:
measure: Time to onset of bronchodilator effect and maximum effect
timeFrame: 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
measure: Adverse Events
timeFrame: predose and up to 24 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Neutec Ar-Ge San ve Tic A.S Clinical Trial
name: Neutec Ar-Ge San ve Tic A.S
role: STUDY_DIRECTOR
References:
citation: Yildiz P, Bayraktaroglu M, Gorgun D, Secik F. Bronchodilator efficacy of 18 mug once-daily tiotropium inhalation via Discair(R) versus HandiHaler(R) in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial. Int J Chron Obstruct Pulmon Dis. 2016 Nov 22;11:2859-2867. doi: 10.2147/COPD.S119114. eCollection 2016.