Version: 1.0.0 | Published: 26 Jun 2025 | Updated: 164 days ago
NOVELTY Study (NOCD)
Dataset
Documentation
Description:
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.
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.
Exposure(s):
The NOVELTY study is a longitudinal cohort study which does not involve or study a specific medicinal product; it will constitute a disease registry. Information about exposure to treatments as part of routine care will be collected (frequency, treatment, duration).
Sample Size Estimations:
The target minimum number of 100 patients per diagnostic label (asthma or COPD), physician-assessed severity level and country has been chosen to support many basic local reimbursement specific requirements with reasonable precision, and to provide large sample size for scientific questions applicable across severities and countries. Therefore, considering the targeted countries, it is estimated that approximately 7,700 patients with asthma and 7,100 patients with COPD will be enrolled.
Statistical Analysis:
After baseline data collection and each annual data collection, data will be summarized for the population overall and by pre specified subgroups, including by country, demographics, exposures, symptom history, treatment history, concurrent clinical features, treatment setting, socioeconomic setting and access to healthcare, where relevant.
Patients’ changes regarding their treatment, disease or severity among and other variables that are observed between baseline and follow-up visits, will also be described.
To identify potential differences in disease diagnosis and severity classifications between physicians and guidelines, data collected on lung function results, symptom questionnaires, exacerbation occurrences and medication will allow the formal and consistent classification of the patients according to relevant international guidelines and other current and future phenotypic/diagnostic classifications.
More information on NOVELTY can be found here: https://www.astrazenecaclinicaltrials.com/study/D2287R00103/
Please note: the NOCD is a standalone dataset, and cannot be linked with other SAIL datasets.
Coverage
Spatial:
United Kingdom, Wales
Typical Age Range:
12-130
Pathway:
Study
Provenance
Origin
Purposes:
Disease registry
Sources:
EPR
Collection Situations:
Cohort, study, trial
Temporal
Accrual Periodicity:
Static
Start Date:
25 July 2016
End Date:
30 July 2023
Time Lag:
Other
Accessibility
Access
Access Service:
The SAIL Databank is powered by the UK Secure e-Research Platform (UKSeRP).
Following approval through safeguard processes, access to project-specific data
within the secure environment is permitted using two-factor authentication.
Access Request Cost:
Data provision is free from SAIL. Overall project costing depends on the number
of people that require access to the SAIL Gateway, the activities that SAIL
needs to complete (e.g. loading non-standard datasets), data refreshes,
analytical work required, disclosure control process, and special case
technological requirements.
Delivery Lead Time:
2-6 months
Jurisdictions:
UK
Data Controller:
SAIL
Data Processor:
SAIL Databank
Usage
Data Use Limitations:
General research use
Data Use Requirements:
- Project-specific restrictions
- User-specific restriction
- Time limit on use
Format and Standards
Vocabulary Encoding Schemes:
LOCAL
Conforms To:
LOCAL
Languages:
en
Formats:
SQL database table
Observations
Statistical Population
Population Description
Population Size
Measured Property
Observation Date
Persons
Actual enrollment in study
12255
Count
30 May 2023