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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00621582
First received: February 13, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition
Pulmonary Disease, Chronic Obstructive

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: Yes ]
    Patient tolerability assessment classified as "Unsatisfied", "Satisfied", "Good" and "Very Good"


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: Yes ]
    The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8)


Enrollment: 4918
Study Start Date: May 2006
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Study Design:

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621582

Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00621582     History of Changes
Other Study ID Numbers: 205.373
Study First Received: February 13, 2008
Results First Received: February 9, 2010
Last Updated: February 27, 2014
Health Authority: China:

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on April 16, 2014