Spiriva® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Tolerability and Efficacy of Spiriva® 18 Micrograms in Patients With COPD in Daily Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172482
• Other study ID #: 205.277
• Status: Completed
• Phase: N/A
• First received: June 20, 2014
• Last updated: June 20, 2014
• Start date: June 2002

Study information

• Verified date: June 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

As part of the post-marketing surveillance, information is to be gathered regarding the tolerance and efficacy of Spiriva® 18 micrograms in patients with COPD under conditions of daily practice

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63127
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Men and women aged at least 40 years presenting with the symptoms of COPD

Exclusion Criteria:

• Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium bromide
Tiotropium bromide18 micrograms (capsule with powder for inhalation)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in breathlessness when walking/climbing stairs		Baseline, after 4 weeks	No
Primary	Change from baseline in overall severity of the clinical picture		Baseline, after 4 weeks of treatment	No
Primary	Occurrence of Adverse Events		up to 4 weeks	No
Primary	Change from baseline in breathlessness on Physical exercise		Baseline, after 4 weeks	No
Primary	Change from baseline in breathlessness during housework		Baseline, after 4 weeks	No
Primary	Change from baseline in breathlessness during everyday activities		Baseline, after 4 weeks	No

External Links

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