NCT07556159|Recruiting

A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice

AIRITY

A Hybrid Cross-sectional and Prospective Study to Assess Patient Characteristics, Disease Burden, Disease Control, Phenotypes, Endotypes, and Outcomes in a Real-world Setting in Patients With Asthma

Sanofi ClinicalTrials.gov

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3 other identifiers

PIR211912025-524916-13-00U1111-1336-5183

Study Type

observational

Target

2,500

Locations

3 countries

Sites

Timeline

RegisteredApr 2026

StartedApr 2026

CompletionApr 2029

Brief Summary

The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and both disease-specific and generic health-related quality of life. The study consists of two parts: a cross-sectional study, and a prospective follow-up evaluate changes in disease trajectories in participants with asthma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,500

participants targeted

Target at P75+ for all trials

Timeline

33mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach

3 countries

54 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 years study duration

Study Progress11%

Apr 2026Apr 2029

First Submitted

Initial submission to the registry

March 31, 2026

Completed

1 day until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed

28 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2029

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

March 31, 2026

Last Update Submit

July 23, 2026

Conditions

Asthma

Keywords

Cross-SectionalMulticenterInhaled Corticosteroids

Outcome Measures

Primary Outcomes (7)

Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities
Descriptive Statistical Analyses may include sociodemographic and clinical characteristics, comorbidities, exacerbation history, medication burden, biomarkers and lung function.
Part 1: At baseline
Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma
ACQ-5 is a 5-question survey. The five ACQ-5 questions are scored on a 6-point scale (0 = good control, 6 = poor control), and the overall score is the mean of the five responses. Participant's scores are then classified into three prescribed groups as having well-controlled asthma (score ≤ 0.75); partially controlled asthma (score 0.75-1.5), or not well controlled asthma (score \>1.5). A change in ACQ-5 score of 0.5 is considered the minimal clinically important difference (MCID)
Part 1: At baseline
Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma
The Asthma Quality of Life Questionnaire (AQLQ) includes 32 items, The mini-AQLQ is a reduced version of the AQLQ which includes 15 items. The questions correspond to 4 dimensions of health: symptoms (5 items), limitation of usual activities (4 items), emotional function (3 items) and environmental stimuli (3 items). The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability. Higher scores indicating better quality of life (less impairment) and lower scores indicating worse quality of life (greater impairment).
Part 1: At baseline
Part 1: Physician Global Assessment of Asthma Severity and Symptom Control
Asthma severity, asthma control, and comorbidity will be assessed using three global impression of severity items: Physician Global Impression of Severity (PhGIS) - asthma severity. PhGIS - asthma control, and PhGIS - comorbidity.
Part 1: At baseline
Part 2: Descriptive Statistical Analysis of Difference in Asthma Symptom Control (ACQ-5) Between Part 2 Cohorts A1 and A2
Data on participant's asthma symptoms and control will be collected via the ACQ-5, 5-question survey. The five ACQ-5 questions are scored on a 6-point scale (0 = good control, 6 = poor control), and the overall score is the mean of the five responses. Participant's scores are then classified into three prescribed groups as having well-controlled asthma (score \<=0.75); partially controlled asthma (score 0.75-1.5), or not well controlled asthma (score \>1.5). A change in ACQ-5 score of 0.5 is considered the MCID.
Part 2: At Weeks 52 and 104
Part 2: Number of Participants Analyzed with Treatment Utilization Pattern between Part 2 Cohorts A1 and A2
Treatment utilization will include systemic corticosteroids (SCS), ICS, and short-acting beta agonists (SABA). Number of participants with various treatment utilization pattern will be assessed and reported.
Part 2: At Weeks 52 and 104
Part 2: Descriptive Statistical Analysis of Difference in Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV₁) between Part 2 Cohorts B1 and Cohort B2
Pre-BD FEV₁ is the forced expiratory volume in 1 second measured by spirometry prior to bronchodilator administration.
Part-2: At Weeks 52 and 104

Secondary Outcomes (21)

Part 1: Physician-Reported Outcomes to Characterize Physician Perspectives
Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Their Demographics and Clinical Characteristics
Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Their Disease Burden, Health Status, Treatment Experiences
Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Medication Use
Part 1: From 12 months prior to study enrollment
Part 1: Number of Participants Characterised by Their Lifestyle and Environmental Influences
Part 1: From 12 months prior to study enrollment
+16 more secondary outcomes

Study Arms (5)

Part-1: Participants With Asthma

Participants receiving treatment with low-, medium-, or high-dose inhaled corticosteroids (ICS) and/or biologic therapies as part of standard of care (SoC) for the management of asthma in routine clinical practice.