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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152984
First Posted: September 12, 2005
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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 ]

Secondary Outcome Measures:
  • Forced vital capacity (FVC) [ Time Frame: 12 weeks ]
  • Peak expiratory flow rate (PEFR) [ Time Frame: 12 weeks ]
  • Use of rescue medication [ Time Frame: 12 weeks ]
  • AUC0-6hFEV1 [ Time Frame: after first dose on Day 1 and after 4 weeks of treatment ]
  • Change in trough FEV1 (i.e. trough response) from baseline. [ Time Frame: after 4 and 12 weeks of treatment ]
  • Change in peak FEV1 from baseline (=peak response) after first dose [ Time Frame: after 4 and 12 weeks of treatment ]
  • AUC0-6hFVC defined in the same way as for FEV1. [ Time Frame: Day 1, week 4 ]
  • Trough FVC defined in the same way as for FEV1. [ Time Frame: Day 1, week 4 ]
  • Peak FVC defined in the same way as for FEV1 [ Time Frame: Day 1, week 4 ]
  • Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement). [ Time Frame: 12 weeks ]
  • Weekly average number of puffs of rescue medication used [ Time Frame: 12 weeks ]
  • Occurrence of adverse events [ Time Frame: 12 weeks ]
  • Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry [ Time Frame: 12 weeks ]
  • Change from baseline in Physical examination [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152984


  Show 68 Study Locations
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
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: November 1, 2013
Last Verified: October 2013

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