NCT05169619

Brief Summary

This study aims to determine the prevalence of Asthma, Difficult-to-Treat and Severe Asthma in Portugal, and characterize patients to better understand their disease characteristics, treatment profile and health care resource use to improve clinical management of the disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
842

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

37 active sites

Status
completed

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

Study Start

First participant enrolled

April 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2024

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

November 15, 2021

Last Update Submit

March 5, 2025

Conditions

Keywords

AsthmaSevere AsthmaDifficult-to-treat asthmaPrevalence

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with asthma, difficult-to-treat asthma, and severe asthma

    Ratio between the total number of participants with confirmed asthma, difficult-to-treat asthma, and severe asthma and the total number of participants

    From date of inclusion until the end of the study currently planned (2,5 years)

Secondary Outcomes (26)

  • Subject's characteristics - Age

    From date of inclusion until the end of the study currently planned (2,5 years)

  • Subject's characteristics - Living in a city or rural community

    From date of inclusion until the end of the study currently planned (2,5 years)

  • Subject's characteristics - Family history

    From date of inclusion until the end of the study currently planned (2,5 years)

  • Subject's characteristics - Comorbidities and allergies

    From date of inclusion until the end of the study currently planned (2,5 years)

  • Subject's characteristics - Obesity

    From date of inclusion until the end of the study currently planned (2,5 years)

  • +21 more secondary outcomes

Eligibility Criteria

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

The population of study will be adult (=\> 18 years) persons registered in the Portuguese National health service patients' database. Participants will be enrolled in the study according to proportionate allocation from primary care health units that will be identified based on demographic stratification (i.e. NUTS III)

You may qualify if:

  • Adults =\>18 years old registered in Portuguese National Health service patients' database of primary care units.
  • Give voluntary signed informed consent,
  • Ability to understand ans answer questionnaires.

You may not qualify if:

  • Participants that have a physical condition that could interfere with the study assessments or prevent the participant from adequately participating in the study (e.g. mobility problems, not able to perform spirometry,…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Research Site

Alpendorada, Portugal, 4575-029, Portugal

Location

Research Site

Vila Cova Da Lixa, Portugal, 4615-604, Portugal

Location

Research Site

Aradas, 3810-437, Portugal

Location

Research Site

Arazede, 3140-022, Portugal

Location

Research Site

Braga, 4700-395, Portugal

Location

Research Site

Cascais, 2750-642, Portugal

Location

Research Site

Coimbra, 3030-790, Portugal

Location

Research Site

Evora, 7005-389, Portugal

Location

Research Site

Evora, 7005-451, Portugal

Location

Research Site

Fafe, 4820-273, Portugal

Location

Research Site

Leiria, 2410-272, Portugal

Location

Research Site

Lisbon, 1749-080, Portugal

Location

Research Site

Lisbon, 1769-001, Portugal

Location

Research Site

Lisbon, 1800-192, Portugal

Location

Research Site

Mafra, 2640-465, Portugal

Location

Research Site

Montenegro, 8005-518, Portugal

Location

Research Site

Oeiras, 2780-163, Portugal

Location

Research Site

Ovar, 3880-225, Portugal

Location

Research Site

Pinhal Novo, 2955-050, Portugal

Location

Research Site

Ponte, 4805-273, Portugal

Location

Research Site

Porto, 4050-046, Portugal

Location

Research Site

Porto, 4100-203, Portugal

Location

Research Site

Porto, 4450-021, Portugal

Location

Research Site

Porto, 4460-282, Portugal

Location

Research Site

Queluz, 2745-862, Portugal

Location

Research Site

Quinta Do Conde, 2975-326, Portugal

Location

Research Site

Ribeira de Pena, 4870-162, Portugal

Location

Research Site

Rio de Mouro, 2635-364, Portugal

Location

Research Site

Tavira, 8800-534, Portugal

Location

Research Site

Tomar, 2300-469, Portugal

Location

Research Site

Tondela, 3460-541, Portugal

Location

Research Site

Viana do Castelo, 4900-369, Portugal

Location

Research Site

Vila do Conde, 4480-807, Portugal

Location

Research Site

Vila Nova da Barquinha, 2260-400, Portugal

Location

Research Site

Vila Nova de Gaia, 4400-712, Portugal

Location

Research Site

Vila Real, 5000-557, Portugal

Location

Research Site

Vouzela, 3670-261, Portugal

Location

Related Publications (1)

  • Jacome C, Brito D, Joao C, Lopes F, Santos J, Amorim L, Barbosa MJ, Pardal M, Teixeira P, Bernardo F, Fonseca JA, Correia-de-Sousa J. EPI-ASTHMA study protocol: a population-based multicentre stepwise study on the prevalence and characterisation of patients with asthma according to disease severity in Portugal. BMJ Open. 2022 Sep 19;12(9):e064538. doi: 10.1136/bmjopen-2022-064538.

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • JoĂ£o Fonseca, MD/PhD

    cintesis

    PRINCIPAL INVESTIGATOR
  • Jaime Correia de Sousa, MD/PhD

    ICVS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 27, 2021

Study Start

April 30, 2021

Primary Completion

March 6, 2024

Study Completion

March 6, 2024

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations