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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541006
• Other study ID #: Neu-21.12
• Status: Completed
• Phase: Phase 4
• Start date: November 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2013
• Source: Neutec Ar-Ge San ve Tic A.S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• Tiotropium 18 mcg
tiotropium 18 mcg once a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neutec Ar-Ge San ve Tic A.S

References & Publications (1)

Yildiz P, Bayraktaroglu M, Gorgun D, Secik F. Bronchodilator efficacy of 18 µg once-daily tiotropium inhalation via Discair(®) versus HandiHaler(®) 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. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	- 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	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
Secondary	Adverse Events		predose and up to 24 hours postdose