Observational Study of Obstructive Lung Disease (NOVELTY)

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.

Multivariable models will be used to assess the following: the occurrence of exacerbations
and other conditions, including upper and lower Respiratory Tract Infections (RTIs) and their
relationship with clinical outcomes, the relationship between Patient Reported Outcomes (PRO)
and disease control with impact on daily activity and quality of life, and the relationship
between healthcare resource use overall and related to respiratory diseases with disease
severity, clinical outcomes, disease type, etc.

Multivariable analysis techniques will be used to identify phenotypes and endotypes, based on
biomarkers and/or clinical parameters that are associated with differential outcomes for
symptom burden, clinical evolution and healthcare utilisation.

Inclusion Criteria:

- Diagnosis, or suspected diagnosis, of asthma and/or COPD, according to clinician`s
judgment

- Age: 12 years or older (note: in most countries it will only be feasible to include
patients aged 18 years or older)

- Willing and able to sign written, informed consent (or having a responsible, legally
authorised representative acting on patient's behalf)

- Enrolment from an active clinical practice

Exclusion Criteria:

- Patients who participated in any respiratory interventional trial during the 12 months
prior to enrolment or at enrolment

- Patients who, in the opinion of the physician, are unlikely to complete 3 years of
follow-up, e.g. poor literacy, substance abuse, life-threatening co-morbidity

- Patients whose primary respiratory diagnosis (i.e. the condition causing most of their
respiratory symptoms) is not asthma or COPD (however, a co-diagnosis of another
respiratory disease such as bronchiectasis or interstitial lung disease together with
asthma or COPD will be accepted)

In addition, the following are considered criteria for exclusion from the exploratory
genetic research (donation of blood for DNA and RNA analysis)

- Previous allogeneic bone marrow transplant

- Non-leukocyte depleted whole blood transfusion within 120 days of the date of the
genetic sample collection