Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Patient Registry of Roflumilast In Real Life
Verified date | May 2017 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.
Status | Completed |
Enrollment | 1950 |
Est. completion date | August 31, 2016 |
Est. primary completion date | August 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Signed informed consent to the data collection - Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry Exclusion Criteria: There are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Bulgaria, Greece, Hong Kong, Korea, Republic of, Norway, Slovakia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of observed exacerbations | Number of exacerbations observed during the study period and per patient per year | 12 months | |
Secondary | Severity of exacerbations | Severity of exacerbations (proportion of exacerbations requiring systemic corticosteroid treatment and/or antibiotics or requiring hospitalization). | 12 months | |
Secondary | Seasonal variation of exacerbation | Seasonal variation of exacerbation during Roflumilast treatment. | 12 months | |
Secondary | Number of hospitalizations due to COPD exacerbations | Number of hospitalizations due to Chronic obstructive pulmonary disease (COPD) exacerbations per patient per year. | 12 months | |
Secondary | Change from Baseline in lung function parameters (FEV1 and FEV1/FVC) | Change in lung function parameters parameters FEV1(Forced Expired Volume measured after 1 second expiration) and FEV1/FVC (Forced Vital Capacity) from Baseline to the last recorded value and to the end of the study. | Baseline and Month 12 | |
Secondary | Change from Baseline in blood oxygen saturation | Change in blood oxygen saturation assessed with pulse oximetry from Baseline to the last recorded value and the end of the study. | Baseline and Month 12 | |
Secondary | Percentage of compliance to treatment | Estimated percentage of prescribed doses taken since the last date of data collection. | 12 months | |
Secondary | Changes in concomitant administration of COPD maintenance treatments | Changes in concomitant administration of COPD maintenance treatments since start of roflumilast treatment. | 12 months | |
Secondary | Health status using the COPD Assessment Questionnaire (CAT) | Baseline, Month 6 and Month 12 | ||
Secondary | Change from Baseline in breathlessness | Change in breathlessness assessed using the Modified Medical Research Council (mMRC) dyspnoea scale, from Baseline to the end of observation. | Baseline and Month 12 | |
Secondary | Number of Participants with adverse Drug Reactions (ADRs) | An ADR is a response to an observed medicinal product which is noxious and unintended resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product. | 12 months |
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