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

NCT00621582 | Completed Results

• 1 other identifier: 205.373
• Study Type: observational
• Target: 4,918
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  0 weeks (Visit 1) and 8 weeks (Visit 3)

• Patient Tolerability Assessment at Visit 3

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

  8 weeks (Visit 3)

Secondary Outcomes (2)

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

  2 weeks (Visit 2 and 8 weeks (Visit 3)

• Physician Tolerability Assessment at Visit 3

  8 weeks (Visit 3)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 22, 2008
• Study Start: May 1, 2006
• Primary Completion: February 1, 2008
• Last Updated: October 23, 2014
• Results First Posted: June 15, 2010

Record last verified: 2014-10