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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00621582
First received: February 13, 2008
Last updated: May 18, 2012
Last verified: May 2012
History of Changes

February 13, 2008
May 18, 2012
May 2006
February 2008   (final data collection date for primary outcome measure)
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)
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Complete list of historical versions of study NCT00621582 on ClinicalTrials.gov Archive Site
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Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities
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.

Study Design:
Observational
Time Perspective: Prospective
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Non-Probability Sample

primary care clinic
Pulmonary Disease, Chronic Obstructive
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4918
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February 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00621582
205.373
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Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP