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OpenTrials
Completed

NCT Number: NCT02172482

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

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

Completed

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiotropium Bromide

Drug

Tiotropium bromide18 micrograms (capsule with powder for inhalation)

Other names: Spiriva®

Primary outcomes

  1. Change from baseline in breathlessness when walking/climbing stairs

    Time frame: Baseline, after 4 weeks

  2. Change from baseline in overall severity of the clinical picture

    Time frame: Baseline, after 4 weeks of treatment

  3. Occurrence of Adverse Events

    Time frame: up to 4 weeks

  4. Change from baseline in breathlessness on Physical exercise

    Time frame: Baseline, after 4 weeks

  5. Change from baseline in breathlessness during housework

    Time frame: Baseline, after 4 weeks

  6. Change from baseline in breathlessness during everyday activities

    Time frame: Baseline, after 4 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
First posted
Jun 24, 2014
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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