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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014