Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities

The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients with COPD of varying severities over 8 weeks.

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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

About this study

Study Design:

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Incl. Criteria Patients with clinical diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) according to definition of China COPD guideline.

Patients over 40 years old

Exclusion criteria

Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva® Patient with known narrow-angle glaucoma

Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction
Patient with known moderate to severe renal impairment (i.e.,creatinin clearance<=50ml/min)
Pregnant or nursing women
Patient with any significant disease other than COPD which would exclude him/her from participating in the study
Patients with any conditions listed in [special precautions], [drug interactions], and [contraindication] of Spiriva® China package insert
Patients with signed informed consent of any other study

Treatment and study plan

Primary outcomes

Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)

Time frame: 0 weeks (Visit 1) and 8 weeks (Visit 3)

The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least).

Represents number of participants who score ""good"" and ""excellent"" at visit 1 (0 weeks) and visit 3 (8 weeks)
Patient Tolerability Assessment at Visit 3

Time frame: 8 weeks (Visit 3)

Patient tolerability assessment classified as "Unsatisfied", "Satisfied", "Good" and "Very Good"

Secondary outcomes

Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)

Time frame: 2 weeks (Visit 2 and 8 weeks (Visit 3)

The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8;

Represents number of participants who score ""good"" and ""excellent"" at visit 2 (2 weeks) and visit 3 (8 weeks)
Physician Tolerability Assessment at Visit 3

Time frame: 8 weeks (Visit 3)

The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2008
First posted: Feb 22, 2008
Registry last updated: Oct 23, 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.

Published trials that share one or more normalized conditions with this study.

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