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Completed

NCT Number: NCT07013760

Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain

Observational retrospective study to characterize and assess clinical outcomes of patients receiving tezepelumab after marketing approval in Spain

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–105 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Andalucia, Spain

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About this study

T-ROSS-II has been designed to conduct a new observational study to generate additional evidence on the use of tezepelumab in severe asthma patients in routine clinical practice in Spain after its launch.

This is an observational, multi-centre, retrospective, single-arm study in patients 12 years and older with severe asthma.

Approximately 400 patients meeting the study eligibility criteria will be included in the T-ROSS-II.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who received at least 1 tezepelumab dose after commercialization in Spain diagnosed with severe asthma who are inadequately controlled with high-dose inhaled corticosteroids and a long-acting β2-agonist ± additional medications for asthma control.

  • Patients aged ≥12 years at the index date.
  • Patients with continuous enrolment in the data source for at least 12-months before the index date.
  • Patients with at least three months of continuous enrolment in the data source after the index date.

Exclusion criteria

Patients who received tezepelumab or any biologic drug for the treatment of asthma in a clinical trial at any time during the 12-months prior to the index date*.

  • Patients who had initiated 3 or more non-tezepelumab biologic treatment (omalizumab, mepolizumab, reslizumab, benralizumab and dupilumab) for severe asthma at any time prior to the index date).

Treatment and study plan

Primary outcomes

  1. 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 )

    Time frame: Index date (treatment initiation with tezepelumab)

    To describe the demographic characteristics of patients

  2. Exacerbation (number of exacerbations)

    Time frame: 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)

  3. 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.)

    Time frame: From 12 months before index date until index date (defined as the date of treatment initiation with tezepelumab)

  4. Number of respiratory infections and diseases in the previous 12 months and index date

    Time frame: From 12 months before index date until index date (defined as the date of treatment initiation with tezepelumab)

  5. Number of participants with an Allergy test (Prick test, RAST or similar, clinical relevance of allergy, etc.) (only baseline)

    Time frame: Only on the baseline (12 months prior to Index date)

Secondary outcomes

  1. Asthma Control Test (ACT)

    Time frame: 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)

    A short, simple, patient-based tool for identifying subjects with poorly controlled asthma. ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The seores range from 5 (poor control of asthma) to 25 (complete control of osthmo), with higher seores reflecting greater asthma control. An ACT score >19 indicates well controlled asthma. The investigators will use the Spanish validation

  2. Lung function measurements

    Time frame: 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)

    Lung function measurements including spirometry (FEV1 (L))

  3. FeNO (ppb)

    Time frame: 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)

  4. Blood neutrophil count (109 /L, mm^3)

    Time frame: 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)

  5. IgE (IU/mL)

    Time frame: 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)

  6. Asthma Impairment and Risk Questionnaire (AIRQ)

    Time frame: 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)

    The score range from 1 to 10. Scores from 0-1 indicate well controlled-asthma. From 2-4 no well-controlled and ≥ 5 bad control.

  7. Asthma Quality of Life Questionnaire (AQLQ)

    Time frame: 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)

    It is a validated scale with 32 questions. The questions are scored on a scale of 1- 7, with higher scores indicating better quality of life.

  8. MiniAQLQ (Mini Asthma Quality of Life Questionnaire)

    Time frame: 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)

    This instrument has 15 questions. The questions are scored on a scale of 1- 7, with higher scores indicating better quality of life.

  9. SNOT-22 (Sino-Nasal Outcome Test)

    Time frame: 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)

    It consists of 22 items, rated from 0 ('no problem at all') to 5 ('worst possible symptom'). Possible SNOT-22 total-scores range from 0 to 110, with higher SNOT-22 total-scores indicating worse symptoms.

  10. Blood eosinophil count (BEC) (109 /L, mm^3)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Observational Retrospective Study to Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain

Acronym: T-ROSS-II

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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