NCT04180319: EARCO

EARCO REGISTRY. History Of Patients With Alpha-1 Antitrypsin

Status unknown Last updated 7 February 2020

What this trial tests

trial in Alpha 1-Antitrypsin Deficiency in 3,000 participants. Status unknown.

Timeline

5 February 2020

Primary endpoint
5 February 2021

5 February 2025

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	3,000
Start date	5 February 2020
Primary completion	5 February 2021
Estimated completion	5 February 2025
Sites	1 location across Spain

Conditions studied

• Alpha 1-Antitrypsin Deficiency — all drugs for Alpha 1-Antitrypsin Deficiency →

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

Eligibility, any sex, with Alpha 1-Antitrypsin Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

European Alpha-1 Research Collaboration (EARCO) is a pan-European network committed to promoting clinical research and education in alpha-1 antitrypsin deficiency (AATD). The core project is the pan-European AATD Registry, a collaboration which will offer longitudinal real-world data for patients with AATD. EARCO has a global vision to increase the early diagnosis of alpha-1 antitrypsin deficiency (AATD), understand better the natural history of the disease and ensure optimal access to effective care, placing emphasis on ambitions that serve collective needs of the AATD research community and bringing people with AAT deficiency to the centre of the research environment in a real-world context.

The study population will consist of individuals with diagnosed severe alpha-1 antitrypsin deficiency regardless of the clinical expression and severity.

The study objectives are:

* To generate long-term, high-quality clinical data covering a pan-European population of AATD individuals in all age groups and all stages of disease severity.
* To understand the natural history and prognosis of AATD better with the goal to create and validate prognostic tools to support medical decision making.
* To investigate the effect of augmentation therapy on the progression of emphysema and to examine its impact on clinical and functional outcomes, such as FEV1, quality of life and mortality in a "real-life" population
* To learn more about the course of the disease in patients suffering from severe AATD with genotypes different from Pi\*ZZ We expect to collect detailed information from around 1,000 patients from at least 10 countries during the first year, expanding to 3,000 from more than 25 countries over the 5 years of the CRC and continue a long term follow-up.

We expect to collect detailed information from around 1,000 patients from at least 10 countries during the first year, expanding to 3,000 from more than 25 countries over the 5 years of the CRC and continue a long term follow-up. .

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical and functional characteristics of individuals with alpha-1 antitrypsin deficiency: EARCO international registry.
   Miravitlles M, Turner AM, Torres-Duran M, Tanash H, et al · · 2022 · cited 35× · PMID 36527073 · DOI 10.1186/s12931-022-02275-4
2. The prevalence of bronchiectasis in patients with alpha-1 antitrypsin deficiency: initial report of EARCO.
   Stockley RA, Pye A, De Soyza J, Turner AM, et al · · 2023 · cited 16× · PMID 37573351 · DOI 10.1186/s13023-023-02830-2
3. Demographic and clinical characteristics of patients with α₁-antitrypsin deficiency genotypes PI*ZZ and PI*SZ in the Spanish registry of EARCO.
   Torres-Durán M, López-Campos JL, Rodríguez-Hermosa JL, Esquinas C, et al · · 2022 · cited 14× · PMID 36171983 · DOI 10.1183/23120541.00213-2022
4. Personalised indication of augmentation therapy for emphysema associated with severe alpha-1 antitrypsin deficiency: a case series.
   Aljama C, Martin T, Granados G, Miravitlles M, et al · · 2024 · cited 8× · PMID 39132722 · DOI 10.1177/17534666241271917
5. Risk of lung disease in the PI*SS genotype of alpha-1 antitrypsin: an EARCO research project.
   Martín T, Guimarães C, Esquinas C, Torres-Duran M, et al · · 2024 · cited 7× · PMID 38926693 · DOI 10.1186/s12931-024-02879-y
6. Predicting Exacerbations in Alpha-1 Antitrypsin Deficiency Using Clinical and Pulmonary Function Tests: Portuguese EARCO Registry.
   Faria N, Gomes J, Guimarães C, Marçôa R, et al · · 2024 · cited 3× · PMID 38531325 · DOI 10.1159/000537759
7. Clinical characteristics of AATD-related COPD patients vary with age at diagnosis: data from the EARCO international registry.
   Karadoğan D, Torres-Duran M, Tanash H, Rodríguez-García C, et al · · 2025 · cited 1× · PMID 40616025 · DOI 10.1186/s12890-025-03782-y
8. Characteristics of bronchiectasis in patients with different genotypes of severe α<sub>1</sub>-antitrypsin deficiency from the EARCO registry.
   Mandurino Mirizzi F, Aljama C, Santus P, Mantero M, et al · · 2026 · PMID 41668877 · DOI 10.1183/23120541.00491-2025