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

NCT ID: NCT02541006

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-08-31

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).

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tiotropium 18 mcg dry powder for inhalation

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

Group Type: EXPERIMENTAL

Tiotropium 18 mcg

Intervention Type: DRUG

tiotropium 18 mcg once a day

SPIRIVA 18 mcg HANDIHALER

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

Group Type: ACTIVE_COMPARATOR

Tiotropium 18 mcg

Intervention Type: DRUG

tiotropium 18 mcg once a day

Interventions

Tiotropium 18 mcg

tiotropium 18 mcg once a day

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neutec Ar-Ge San ve Tic A.Ş

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neutec Ar-Ge San ve Tic A.S

Role: STUDY_DIRECTOR

Neutec Ar-Ge San ve Tic A.S Clinical Trial

References

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.

Reference Type: BACKGROUND

PMID: 27920513 (View on PubMed)

Other Identifiers

Neu-21.12

Identifier Type: -

Identifier Source: org_study_id