NCT05032209

Brief Summary

Most of clinical cohorts focused on the course of asthma over time and on the different phenotypes of asthma have investigated children and adults separately. The passage from childhood to adulthood is scarcely explored. In this context, we decided to explore the course of asthma severity from teenage to adulthood in children with severe asthma. The secondary objectives are to assess the quality of life and socioeconomic status in adulthood. This study will be both retrospective (data collected during childhood) and prospective (data collected during adulthood), multicentric and observational

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 2, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

August 27, 2021

Last Update Submit

August 27, 2021

Conditions

Keywords

childhoodadulthood

Outcome Measures

Primary Outcomes (1)

  • severity and control of asthma in adulthood according to the GINA criteria

    12 months

Interventions

follow-up of children with severe asthma in adulthood

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical cohort of adults patients with severe asthma in childhood

You may qualify if:

  • to be aged at least 18 years old in 2021
  • Have had an evaluation for severe asthma during childhood at Trousseau Hospital or Robert Debré Hospital

You may not qualify if:

  • Patient without severe asthma at the time of the assessment in childhood
  • Patient with an associated respiratory disease other than asthma (bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia) whose diagnosis has been invalidated or confirmed during the initial assessment
  • Patient opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Flore AMAT, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 2, 2021

Study Start

July 12, 2021

Primary Completion

July 12, 2022

Study Completion

July 12, 2022

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations