Drug Use Survey of RESPIMAT in Patients With COPD

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT01145053
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate safety and effectiveness information on the use of Tiotropium Respimat for long time of period in daily practical clinical circumstances, and to obtain proper drug use information.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-12-18
• Results First Submitted QC: 2012-12-18
• Results First Posted: 2013-01-30
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	Week 52	The number of patient with any AEs, patients with drug-related AEs

Secondary Outcome Measures

Name	Time	Method
Amount of Sputum	Week 0 and Week 52	Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.
Nocturnal Sleep	Week 0 and Week 52	Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night.
Effectiveness	Week 52	Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician.
Forced Expiratory Volume in One Second (FEV1)	Week 0 and Week 52	FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.
Cough Frequency	Week 0 and Week 52	Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.
Shortness of Breath	Week 0 and Week 52	Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day.