NOVELTY

• Research type

  Research Study

• Full title

  A NOVEL observational longiTudinal studY on patients with a diagnosis or suspected diagnosis of asthma and/or COPD to describe patient characteristics, treatment patterns and the burden of illness over time and to identify phenotypes and endotypes associated with differential outcomes that may support future development of personalised treatment strategies.

• IRAS ID

  199809

• Contact name

  Tim Harrison

• Contact email

  tim.harrison@nottingham.ac.uk

• Sponsor organisation

  AstraZeneca AB

• Clinicaltrials.gov Identifier

  NCT02760329

• Clinicaltrials.gov Identifier

  227190, PAREXEL Number

• Duration of Study in the UK

  4 years, 0 months, 30 days

• Research summary

  The NOVELTY study is a multi-country, multicentre, observational, prospective, longitudinal cohort study which will include patients with a physician diagnosis, or suspected diagnosis, of asthma and/or COPD. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. All patients enrolled in the NOVELTY study will be followed up yearly by their treating physician for a total duration of three years. In addition, patients are expected to be followed up remotely once every quarter.

  Data for the NOVELTY study population will come from several different sources:
  electronic Case Report Form (eCRF), Patient Reported Outcomes (PRO), centralised spirometry data, biological data and Electronic Medical Records (EMR)(some countries, including the UK). The core of the data collection will come from the eCRF, which will be implemented in all countries and will therefore provide a consistently collected set of variables aligned to the study objectives. These data will be enriched by PRO, functional measurements and biospecimen sample collection (when voluntarily consented). In the countries in which EMR data are extracted, both eCRF and EMR will be used as source of patient’s information and the eCRF will be used as a reference to validate the adequacy of existent EMR.

  It is estimated that approximately 7,700 patients with suspected or primary diagnosis of asthma and 7,100 patients with suspected or primary diagnosis of COPD will be enrolled by a diverse set of physicians (e.g. primary care physicians, allergists, pulmonologists) from community and hospital outpatient settings within the countries targeted for NOVELTY.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  16/EM/0439

• Date of REC Opinion

  30 Dec 2016

• REC opinion

  Further Information Favourable Opinion