Drug Use Survey of RESPIMAT in Patients With COPD
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|ClinicalTrials.gov Identifier: NCT01145053|
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : January 30, 2013
Last Update Posted : March 27, 2014
|Condition or disease|
|Pulmonary Disease, Chronic Obstructive|
|Study Type :||Observational|
|Actual Enrollment :||361 participants|
|Official Title:||Long Time Survey of RESPIMAT in Daily Clinical Use|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
- Incidence of Adverse Events (AEs) [ Time Frame: Week 52 ]The number of patient with any AEs, patients with drug-related AEs
- Effectiveness [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
- Amount of Sputum [ Time Frame: 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.
- Shortness of Breath [ Time Frame: 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.
- Nocturnal Sleep [ Time Frame: 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.
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): NCT01145053
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|