Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma - 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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A 12-week Randomised, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Efficacy and Safety of Inhaled Tiotropium 18μg q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma

Resource links provided by NLM:

Drug Information available for: Tiotropium bromide

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:

AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose) [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Forced vital capacity (FVC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Peak expiratory flow rate (PEFR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Use of rescue medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
AUC0-6hFEV1 [ Time Frame: after first dose on Day 1 and after 4 weeks of treatment ] [ Designated as safety issue: No ]
Change in trough FEV1 (i.e. trough response) from baseline. [ Time Frame: after 4 and 12 weeks of treatment ] [ Designated as safety issue: No ]
Change in peak FEV1 from baseline (=peak response) after first dose [ Time Frame: after 4 and 12 weeks of treatment ] [ Designated as safety issue: No ]
AUC0-6hFVC defined in the same way as for FEV1. [ Time Frame: Day 1, week 4 ] [ Designated as safety issue: No ]
Trough FVC defined in the same way as for FEV1. [ Time Frame: Day 1, week 4 ] [ Designated as safety issue: No ]
Peak FVC defined in the same way as for FEV1 [ Time Frame: Day 1, week 4 ] [ Designated as safety issue: No ]
Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Weekly average number of puffs of rescue medication used [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Occurrence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in Physical examination [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:	472
Study Start Date:	December 2004
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	40 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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Sponsors and Collaborators

Boehringer Ingelheim

Investigators


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

More Information


ClinicalTrials.gov Identifier:	NCT00152984 History of Changes
Other Study ID Numbers:	205.301
Study First Received:	September 8, 2005
Last Updated:	October 31, 2013
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)

Additional relevant MeSH terms:


Asthma Lung Diseases Chronic Disease Pulmonary Disease, Chronic Obstructive Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Disease Attributes Pathologic Processes	Tiotropium Bromide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Parasympatholytics Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016