Patient Registry of Roflumilast In Real Life

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Patient Registry of Roflumilast In Real Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015767
• Other study ID #: RO-2455-407-RD
• Secondary ID: U1111-1146-5619
• Status: Completed
• Phase: N/A
• First received: December 13, 2013
• Last updated: June 21, 2017
• Start date: February 1, 2013
• Est. completion date: August 31, 2016

Study information

• Verified date: May 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.

Description:

The drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. Roflumilast is approved for and marketed globally for maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.

This study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. The study will enroll approximately 1350 (EU)+600(North Asia) patients. This multi-centre trial will be conducted in at least 4 EU and 2 North Asian countries.

The overall time to participate in this study is 12 months. No visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study.

Participants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Greece,  Hong Kong,  Korea, Republic of,  Norway,  Slovakia, 

Outcome

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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