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Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00144339
  Purpose

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium
Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Tiotropium Tiotropium bromide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 Mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The co-primary endpoints are:yearly rate of decline in pre and post bronchodilator FEV1 from day 30 (steady state) until completion of double-blind treatment. [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Spirometry parameters at 6 month intervals over 4 years Exacerbations HRQoL Adverse events [ Time Frame: 4 years ]

Enrollment: 5993
Study Start Date: December 2002
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

Written informed consent, male or female patients 40 years of age or older, smoking history of at least 10 pack years, diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication

Exclusion Criteria:

Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate, Mi in past 6 months, unstable or life threatening arrhythmia in past year, hospitalization for NYHA heart failure class III or IV in past year, active TB, asthma, pulmonary resection, malignancy treated with radiation or chemotherapy in past 5 years, respiratory infection in 4 weeks prior to screening, known hypersensitivity to anticholinergic drugs or components, known moderate to severe renal impairment, known narrow angle glaucoma, significant symptomatic BPH or bladder neck obstruction, need for oxygen therapy >12 hr/day, use of oral corticosteroids at unstable doses or >10 mg/day

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144339

  Show 490 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Publications indexed to this study:
Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 205.235
Study First Received: September 2, 2005
Last Updated: October 29, 2008
ClinicalTrials.gov Identifier: NCT00144339  
Health Authority: Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   Hungary: National Institute of Pharmacy, H-1051 Budapest;   Lithuania: State Medicines Control Agency, LT-01132 Vilnius;   Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych;   Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow;   Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26;   Slovenia: Agency for Medicinal Products, SI-1000 Ljubljana;   Australia: Responsilble Ethics Committee;   New Zealand: Multicentre Ethics Committee/Medsafe;   Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna;   Belgium: Federal Agency for Medicines and Health Products;   United States: Food and Drug Administration;   France: AFFSAPS;   Hong Kong: Dept. of Health of Hong Kong;   Italy: Comitato Etico Az. Osp. Univ. Pisana di Pisa;   Malaysia: Ministry of Health, Malaysia;   Norway: Norwegian Medicines Agency (Statens Legemiddelverk);   Portugal: INFARMED - National Authority of Medicines and Health Products, IP;   Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnología);   Taiwan: Department of Health, Executive Yuan, Taiwan;   Philippines: Department of Health, Republic of the Philippines;   Thailand: Ministry of Public Health;   Finland: National Agency for Medicines;   Singapore: Health Science Authority, Ministry of Health;   Switzerland: Swissmedic;   Turkey: Ministry of Health Central Ethics Committee;   Great Britain: MHRA;   South Africa: Medicines Control Council

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Chronic Disease
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Respiratory System Agents
Parasympatholytics
Disease Attributes
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009