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Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01126437
First received: May 6, 2010
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium 18 mcg
Drug: tiotropium 1.25 mcg (2 actuations/day)
Drug: tiotropium 2.5 mcg (2 actuations/day)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Time to first COPD exacerbation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to death [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough FEV1 over 120 weeks (in a substudy of 1300+ patients) [ Designated as safety issue: No ]
  • Time to first hospitalization associated with COPD exacerbation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of hospitalizations associated with COPD exacerbation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to first major adverse cardiovascular event [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number of COPD exacerbations [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to first moderate to severe COPD exacerbation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Time to death from major adverse cardiovascular event [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 17210
Study Start Date: May 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tiotropium 2.5 mcg and placebo
Patients receive one of the active tiotropium arms daily
Drug: tiotropium 1.25 mcg (2 actuations/day)
soft mist inhaler 2 actuations=2 puffs/day
Active Comparator: tiotropium 18 mcg and placebo
Patients receive one of the active tiotropium arms daily
Drug: Tiotropium 18 mcg
HandiHaler
Experimental: tiotropium 5 mcg and placebo
Patients receive one of the active tiotropium arms daily
Drug: tiotropium 2.5 mcg (2 actuations/day)
soft mist inhaler (2 actuations=2 puffs/day)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
  2. Male or female patients 40 years of age or older.
  3. Patients must be current or ex-smokers with a smoking history of ¿10 pack-years. (Patients who have never smoked cigarettes must be excluded)
  4. All patients must have a diagnosis of COPD (P06-12085), and must meet the following criteria: Relatively stable airway obstruction with a post-bronchodilator FEV1 less than 70% of predicted normal and post-bronchodilator FEV1 / FVC less than 70%

Exclusion criteria:

  1. Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patients ability to participate in the study.
  2. Patients with a recent history (i.e., six months or less) of myocardial infarction.
  3. Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
  4. Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
  5. Known active tuberculosis.
  6. Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126437

  Show 1191 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01126437     History of Changes
Other Study ID Numbers: 205.452, 2009-015713-51
Study First Received: May 6, 2010
Last Updated: November 13, 2013
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
China: Food and Drug Administration
Columbia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Agency for Medicinal Product and Medical Devices
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Georgia: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Guatemala: Ministry of Public Health and Social Assistance
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Malaysia: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Central Committee Research Involving Human Subjects
New Zealand: Multi-Regional Ethics Committee
Norway: Norwegian Medicines Agency
Panama: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines: Bureau of Food and Drugs
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Department of Health
Thailand: Food and Drug Administration
Tunisia: Ministry of Public Health
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014