We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621582
First Posted: February 22, 2008
Last Update Posted: October 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
  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) ]

    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 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) ]

    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)


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621582


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

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00621582     History of Changes
Other Study ID Numbers: 205.373
First Submitted: February 13, 2008
First Posted: February 22, 2008
Results First Submitted: February 9, 2010
Results First Posted: June 15, 2010
Last Update Posted: October 23, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action