Drug Use Survey of RESPIMAT in Patients With COPD
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01145053
First received: June 15, 2010
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
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.
| Condition |
|---|
|
Pulmonary Disease, Chronic Obstructive |
| Study Type: | Observational |
| 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 Pharmaceuticals:
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.
| Enrollment: | 361 |
| Study Start Date: | May 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Treatment |
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
300
Criteria
Inclusion criteria:
Patients with COPD who is expected to be treatable with long term. All patients must have a diagnosis of COPD and register after the start of treatment of Tiotropium Respimat.
Exclusion criteria:
There is no special restriction, because this PMS is an observational investigation under conditions of normal clinical practice. Spiriva Respimat is contraindicated in patients with hypersensitivity to Tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients in Package labelling.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01145053 History of Changes |
| Other Study ID Numbers: | 205.463 |
| Study First Received: | June 15, 2010 |
| Results First Received: | December 18, 2012 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive |
ClinicalTrials.gov processed this record on June 17, 2013