A Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), in Patients With Chronic Obstructive Pulmonary Disease
NCT02203474 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2021-11-09
Summary
The primary objective of this study is to demonstrate the superiority of tiotropium hydrofluoroalkane (HFA) breath actuated inhaler (BAI) to placebo HFA BAI following repeated, once-daily dosing.
Conditions
Interventions
- DRUG
-
Tiotropium HFA BAI 5 mcg
- DRUG
-
Tiotropium 18 mcg Capsule
- DRUG
-
Placebo
Sponsors & Collaborators
-
Teva Branded Pharmaceutical Products R&D, Inc.
lead INDUSTRY
Principal Investigators
-
Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2014-08-31
- Completion
- 2014-08-31
More Related Trials
-
A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS® Inhaler 250/50mcg Plus SPIRIVA HANDIHALER® Inhaler Versus SPIRIVA HANDIHALER® Inhaler Plus Placebo DISKUS® Inhaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
NCT00784550 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Proven Hyperinflation
NCT02172521 ·Status: COMPLETED
-
Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema
NCT00570544 ·Status: COMPLETED
-
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
NCT00281567 ·Status: COMPLETED ·Phase: PHASE3
-
Spiriva® Assessment of FEV1 (SAFE)
NCT00277264 ·Status: COMPLETED ·Phase: PHASE3
-
Tiotropium (Spiriva) Rehabilitation Study
NCT00274521 ·Status: COMPLETED ·Phase: PHASE3
-
Mechanisms of Dyspnea Relief During Exercise in COPD Patients Following Treatment With Tiotropium (Spiriva)
NCT00274027 ·Status: COMPLETED ·Phase: PHASE3
-
Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders
NCT00274014 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
NCT00144339 ·Status: COMPLETED ·Phase: PHASE3
-
12 Week Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD According to Swedish Guidelines (SPIRIMILD)
NCT00144196 ·Status: COMPLETED ·Phase: PHASE4
-
Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD
NCT00274053 ·Status: COMPLETED ·Phase: PHASE3
-
SPIRIVA in Ususal Care
NCT00274079 ·Status: COMPLETED ·Phase: PHASE4
-
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 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice
NCT00624377 ·Status: COMPLETED
-
Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease
NCT01126437 ·Status: COMPLETED ·Phase: PHASE3
-
Tiotropium Handihaler vs. Tiotropium Respimat in COPD
NCT05838703 ·Status: WITHDRAWN ·Phase: PHASE2
-
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT03118765 ·Status: COMPLETED ·Phase: PHASE2
-
12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
NCT00240435 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of the Lung Deposition Rate and Distribution Pattern of Tiotropium Via HandiHalerTM in Healthy Subjects and Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02172456 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 4 COPD and Suboptimal Inspiratory Flow Rate
NCT05165485 ·Status: COMPLETED ·Phase: PHASE4
-
Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)
NCT00662740 ·Status: TERMINATED ·Phase: PHASE3
-
PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
NCT01566773 ·Status: COMPLETED ·Phase: PHASE2
-
Bioequivalence Study of Tiotropium Bromide Inhalation Powder
NCT05161156 ·Status: COMPLETED ·Phase: PHASE3
-
Investigate the Impact of Early Treatment Initiation With Tiotropium in Patients Recovering From Hospitalization for an Acute COPD Exacerbation 2
NCT01662986 ·Status: COMPLETED ·Phase: PHASE4
-
Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Dose Compared to Monocomponents in Healthy Male Volunteers
NCT02254174 ·Status: COMPLETED ·Phase: PHASE1