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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive; Asthma	Drug: Tiotropium inhalation capsules; Drug: Placebo inhalation capsules	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	472 participants
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
Study Start Date :	December 2004
Actual Primary Completion Date :	April 2006
Actual Study Completion Date :	April 2006

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. 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 :

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 68 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

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

More Information

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Additional Information:

Related Info 

ClinicalTrials.gov Identifier:	NCT00152984 History of Changes
Other Study ID Numbers:	205.301
First Posted:	September 12, 2005
Last Update Posted:	December 28, 2017
Last Verified:	December 2017

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