12-Week Tiotropium 18?g q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma for Safety and Efficacy - Full Text View

Purpose

The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive Asthma	Drug: Tiotropium inhalation capsules Drug: Placebo inhalation capsules	Phase IV

MedlinePlus related topics:

Asthma COPD (Chronic Obstructive Pulmonary Disease)

ChemIDplus related topics:

Tiotropium Tiotropium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A 12-Week Randomized, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Safety and Efficacy of Tiotropium 18 ?g qd in Patients With COPD and a Pre-Existing Diagnosis of Asthma

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary efficacy endpoint is defined as area under the curve of change in FEV1 from baseline at visit 2 (day 1) for the time period from pre-dose to 6 hours post dose (AUC(0-6hours)FEV1) after 12 weeks of randomised treatment on visit 4 (day 85).

Secondary Outcome Measures:

Secondary endpoints include additional FEV1 and FVC endpoints, morning and evening expiratory flow rate (PEFR), number of puffs of rescue medication (salbutamol), adverse events, pulse rate, systolic and diastolic blood pressure

Estimated Enrollment:	456
Estimated Study Completion Date:	April 2006

Eligibility

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

Criteria

Inclusion criteria:

Diagnosis of COPD and diagnosis of asthma before the age of 30
Current or ex-smokers with a cigarette smoking history of at least 10 pack-years
Treatment with inhaled steroids at least 1 year before study entry
FEV1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years
FEV1 increase of more than 200 mL 30 min. after 400 mcg salbutamol or documented increase of 200 mL after reversibility test within the last 5 years
Post bronchodilator FEV1 less than 80% predicted normal (ECCS) at visit 1
Post bronchodilator FEV1 less than 70% of FVC at visit 1

Exclusion criteria:

Respiratory infection or exacerbation 6 weeks prior to Visit 1 or during run-in period.
Significant diseases other than COPD or asthma
Myocardial infarction within the last 6 months
Unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year
Hospitalisation for heart failure (NYHA Class III or IV) within the last year
History of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
Known active tuberculosis
History of thoracotomy with pulmonary resection
History of cancer within the last 5 years (excluding treated basal cell carcinoma)
Patients requiring oxygen therapy for more than 1 hour per day
Patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before Visit 1
Known hypersensitivity to anticholinergic drugs or lactose

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152984

Show 68 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators


Study Chair:	Boehringer Ingelheim Study Coordinator	B.I. Pharma GmbH & Co. KG

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	205.301
First Received:	September 8, 2005
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00152984
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment; France: National Consultative Ethics Committee for Health and Life Sciences; Germany: BfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte; South Africa: Medicines Control Council; Denmark: Danish Medicines Agency; Canada: Health Canada; Italy: Ministry of Health; Netherlands: Medical Ethics Review Committee (METC)

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Asthma

Chronic Disease

Tiotropium

Respiratory Hypersensitivity

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents

Parasympatholytics

Disease Attributes

Neurotransmitter Agents

Bronchial Diseases

Immune System Diseases

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 October 07, 2008

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00152984