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

Sponsor

Neutec Ar-Ge San ve Tic A.Ş (Industry)

Overall Status

Completed

CT.gov ID

NCT02541006

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: Tiotropium 18 mcg	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tiotropium 18 mcg dry powder for inhalation Tiotropium 18 mcg dry powder for inhalation, one inhalation, once daily with the DISCAIR	Drug: Tiotropium 18 mcg tiotropium 18 mcg once a day
Active Comparator: SPIRIVA 18 mcg HANDIHALER Tiotropium 18 mcg dry powder capsul for inhalation one capsule once daily with the HandiHaler	Drug: Tiotropium 18 mcg tiotropium 18 mcg once a day

Arm

Intervention/Treatment

Experimental: Tiotropium 18 mcg dry powder for inhalation

Tiotropium 18 mcg dry powder for inhalation, one inhalation, once daily with the DISCAIR

Drug: Tiotropium 18 mcg

tiotropium 18 mcg once a day

Active Comparator: SPIRIVA 18 mcg HANDIHALER

Tiotropium 18 mcg dry powder capsul for inhalation one capsule once daily with the HandiHaler

Drug: Tiotropium 18 mcg

tiotropium 18 mcg once a day

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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