Patient Registry of Roflumilast In Real Life

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1950

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria
  • Razgrad, Bulgaria
  • Sofia, Bulgaria
  • Troyan, Bulgaria
  • Vratsa, Bulgaria
• Greece
  • Agrinio, Greece
  • Athens, Greece
  • Edessa, Greece
  • Herakleion-Crete, Greece
  • Imitos, Greece
  • Kaisariani, Greece
  • Kalamaria, Greece
  • Katerini, Greece
  • Nafpaktos, Greece
  • Patras, Greece
  • Peiraias, Greece
  • Peristeri, Greece
  • Ptolemaida, Greece
  • Pyrgos, Greece
  • Thessaloniki, Greece
  • Volos, Greece
• Hong Kong
  • Hong Kong, Hong Kong
• Korea, Republic of
  • Busan, Korea, Republic of
  • Daegu, Korea, Republic of
  • Gwangju, Korea, Republic of
  • Jeonju, Korea, Republic of
  • Seoul, Korea, Republic of
  • Suwon, Korea, Republic of
• Norway
  • Arendal, Norway
  • Bergen, Norway
  • Elverum, Norway
  • Fredrikstad, Norway
  • Kongsvinger, Norway
  • Sandvika, Norway
  • Skien, Norway
  • Straume, Norway
  • Tonsberg, Norway
  • Tønsberg, Norway
• Slovakia
  • Banska Bystrica, Slovakia
  • Bardejov, Slovakia
  • Bratislava, Slovakia
  • Humenne, Slovakia
  • Malacky, Slovakia
  • Michalovce, Slovakia
  • Nitra, Slovakia
  • Povazska Bystrica, Slovakia
  • Presov, Slovakia
  • Revuca, Slovakia
  • Senica, Slovakia
  • Spisska Nova Ves, Slovakia
  • Sturovo, Slovakia
  • Topolcany, Slovakia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization.

The registry sites will comprise hospitals, and office-based physicians. The investigators will be mainly pulmonologists, or as per the standard practice of the specific country.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Roflumilast; Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of observed exacerbations	Number of exacerbations observed during the study period and per patient per year	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of exacerbations	Severity of exacerbations (proportion of exacerbations requiring systemic corticosteroid treatment and/or antibiotics or requiring hospitalization).	12 months
Seasonal variation of exacerbation	Seasonal variation of exacerbation during Roflumilast treatment.	12 months
Number of hospitalizations due to COPD exacerbations	Number of hospitalizations due to Chronic obstructive pulmonary disease (COPD) exacerbations per patient per year.	12 months
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
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
Percentage of compliance to treatment	Estimated percentage of prescribed doses taken since the last date of data collection.	12 months
Changes in concomitant administration of COPD maintenance treatments	Changes in concomitant administration of COPD maintenance treatments since start of roflumilast treatment.	12 months
Health status using the COPD Assessment Questionnaire (CAT)		Baseline, Month 6 and Month 12
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: December 13, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: RO-2455-407-RD; U1111-1146-5619 (Other Identifier: WHO Unique Trial Number)