Clinical trial NCT06487065: Observational Retrospective Study To Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab in the Framework Of Use in Special Situations Prior to Commercialisation in Spain
Official title: Observational Retrospective Study To Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab in the Framework Of Use in Special Situations Prior to Commercialisation in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will consist of all the subjects ≥ 12 years old who have received tezepelumab in the "Foreign medication supply" (FMS) program in Spain. However, some patients may have received tezepelumab under "Foreign medication supply" program as well as marketed tezepelumab, but all of them started while FMS program was in place

Brief summary: The aim of this study is to provide the first results on the use of tezepelumab under clinical practice conditions in severe asthma patients who participated in the "foreign medication supply" program in Spain.


Eligibility criteria: Inclusion Criteria:

* Subjects 12 years and older with severe asthma who were inadequately controlled with high dose inhaled corticosteroids plus another medicinal product
* Received at least one dose of tezepelumab under the FMS program, established according to Royal Decree 1015 / 2009 (prior to commercialization)

Exclusion Criteria:

* Subjects having received tezepelumab or any other biologic for the treatment of asthma in the context of a clinical trial at any time during the 12 months prior to the index date.

Primary outcomes:
measure: Comorbidities (e.g., allergic rhinitis, nasal polyposis, gastroesophageal reflux, chronic obstructive pulmonary disease (COPD), atopic dermatitis and other eosinophilic conditions, conditions related to OCS chronic use, etc.)
timeFrame: 12 months before index date and index date (date of treatment initiation with tezepelumab)
measure: Number of respiratory infections and diseases in the previous 12 months and index date
timeFrame: In the previous 12 months and index date (date of treatment initiation with tezepelumab)
measure: Exacerbations in the previous 12 months and Exacerbations from index date until all available follow-up (number and dates for each exacerbation episode)
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
measure: When available, lung function measurements including spirometry, Inspiratory Capacity, and bronchodilator reversibility test.
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
measure: Blood Eosinophil count (109 /L, mm3 )
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
measure: IgE (IU/mL; kU/mL; ng/mL (mg/L); ng/dL (ng/100mL); ng%)
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
measure: FeNO (ppb)
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
measure: Allergy status (Prick test, RAST or similar, clinical relevance of allergy, etc.) (only baseline)
timeFrame: Only on the baseline (12 months prior to Index date)
measure: Neutrophil count (10 9 /L, mm3 )
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
measure: Sputum biomarkers: sputum eosinophils (%); sputum neutrophils (%)
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
measure: Socio-demographic variables: Age (years), Gender (male, female, other); Smoking status (Current smoker, Ex-smoker, Non-smoker) and cumulative index (packs/year); Height (cm) and weight (kg); Body Mass Index (BMI) (kg/m 2 )
timeFrame: Only on the index date (If no information referred to index date is available, latest available data before the index date)
Secondary outcomes:
measure: Asthma Control Test (ACT)
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
measure: Asthma Impairment and Risk Questionnaire (AIRQ)
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
measure: MiniAQLQ
timeFrame: From 12 months before index date (defined as the date of treatment initiation with tezepelumab) until the end of the follow up which will start after index date and will last up to inclusion (the period will last 9-15 months depending on inclusion date)
Other outcomes:
Locations:
city: Alcazar de San Juan
country: Spain
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Bilbao
country: Spain
facility: Research Site
city: Coslada
country: Spain
facility: Research Site
city: Fuenlabrada
country: Spain
facility: Research Site
city: Gran Canaria
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: San Sebastian
country: Spain
facility: Research Site
city: Talavera de la Reina
country: Spain
facility: Research Site
city: Torrejon de Ardoz
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
Study officials:
References: