Drug Use Survey of RESPIMAT in Patients With COPD
This study has been completed.
Information provided by (Responsible Party):
First received: June 15, 2010
Last updated: February 27, 2014
Last verified: February 2014
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.
Pulmonary Disease, Chronic Obstructive
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Long Time Survey of RESPIMAT in Daily Clinical Use|
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- Incidence of Adverse Events (AEs) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]The number of patient with any AEs, patients with drug-related AEs
Secondary Outcome Measures:
- Effectiveness [ Time Frame: Week 52 ] [ Designated as safety issue: No ]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) [ Time Frame: Week 0 and Week 52 ] [ Designated as safety issue: No ]FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.
- Cough Frequency [ Time Frame: Week 0 and Week 52 ] [ Designated as safety issue: No ]Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.
- Amount of Sputum [ Time Frame: Week 0 and Week 52 ] [ Designated as safety issue: No ]Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.
- Shortness of Breath [ Time Frame: Week 0 and Week 52 ] [ Designated as safety issue: No ]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.
- Nocturnal Sleep [ Time Frame: Week 0 and Week 52 ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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