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

NCT02541006 | Completed Phase 4

• 1 other identifier: Neu-21.12
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Keywords

FEV1; FVC; AUC 0-24; bronchodilator efficacy; tiotropium

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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

Study Arms (2)

Tiotropium 18 mcg dry powder for inhalation

EXPERIMENTAL

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

Drug: Tiotropium 18 mcg

SPIRIVA 18 mcg HANDIHALER

ACTIVE COMPARATOR

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

Drug: Tiotropium 18 mcg

Interventions

Tiotropium 18 mcg DRUG

tiotropium 18 mcg once a day

SPIRIVA 18 mcg HANDIHALER; Tiotropium 18 mcg dry powder for inhalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

Related Publications (1)

• 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.

  PMID: 27920513 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Neutec Ar-Ge San ve Tic A.S

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 4, 2015
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 16, 2020

Record last verified: 2013-11

Data Sharing

• IPD Sharing: Will not share