Clinical trial NCT02015767: Patient Registry of Roflumilast In Real Life
Official title: Patient Registry of Roflumilast In Real Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Drug therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 1950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of observed exacerbations
timeFrame: 12 months
Secondary outcomes:
measure: Severity of exacerbations
timeFrame: 12 months
measure: Seasonal variation of exacerbation
timeFrame: 12 months
measure: Number of hospitalizations due to COPD exacerbations
timeFrame: 12 months
measure: Change from Baseline in lung function parameters (FEV1 and FEV1/FVC)
timeFrame: Baseline and Month 12
measure: Change from Baseline in blood oxygen saturation
timeFrame: Baseline and Month 12
measure: Percentage of compliance to treatment
timeFrame: 12 months
measure: Changes in concomitant administration of COPD maintenance treatments
timeFrame: 12 months
measure: Health status using the COPD Assessment Questionnaire (CAT)
timeFrame: Baseline, Month 6 and Month 12
measure: Change from Baseline in breathlessness
timeFrame: Baseline and Month 12
measure: Number of Participants with adverse Drug Reactions (ADRs)
timeFrame: 12 months
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
city: Razgrad
country: Bulgaria
city: Sofia
country: Bulgaria
city: Troyan
country: Bulgaria
city: Vratsa
country: Bulgaria
city: Agrinio
country: Greece
city: Athens
country: Greece
city: Edessa
country: Greece
city: Herakleion-Crete
country: Greece
city: Imitos
country: Greece
city: Kaisariani
country: Greece
city: Kalamaria
country: Greece
city: Katerini
country: Greece
city: Nafpaktos
country: Greece
city: Patras
country: Greece
city: Peiraias
country: Greece
city: Peristeri
country: Greece
city: Ptolemaida
country: Greece
city: Pyrgos
country: Greece
city: Thessaloniki
country: Greece
city: Volos
country: Greece
city: Hong Kong
country: Hong Kong
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Jeonju
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Arendal
country: Norway
city: Bergen
country: Norway
city: Elverum
country: Norway
city: Fredrikstad
country: Norway
city: Kongsvinger
country: Norway
city: Sandvika
country: Norway
city: Skien
country: Norway
city: Straume
country: Norway
city: Tonsberg
country: Norway
city: Tønsberg
country: Norway
city: Banska Bystrica
country: Slovakia
city: Bardejov
country: Slovakia
city: Bratislava
country: Slovakia
city: Humenne
country: Slovakia
city: Malacky
country: Slovakia
city: Michalovce
country: Slovakia
city: Nitra
country: Slovakia
city: Povazska Bystrica
country: Slovakia
city: Presov
country: Slovakia
city: Revuca
country: Slovakia
city: Senica
country: Slovakia
city: Spisska Nova Ves
country: Slovakia
city: Sturovo
country: Slovakia
city: Topolcany
country: Slovakia
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: