NCT04449419

Brief Summary

The most important pathogenic factor of Chronic Obstructive Pulmonary Disease (COPD) in the Western world is chronic exposure to tobacco smoke, which induces oxidative stress not only in the respiratory system, but in all the body. Mitoquines are circulating hormones directly or indirectly produced by dysfunctional mitochondria, whose function is to protect the body of the consequences of oxidative stress. The objective of this project is to study the modifications that are produced in the serum mitoquines from patients with COPD of varying severity and to assess their potential applications in the clinic.

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
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 26, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

June 26, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

June 19, 2020

Last Update Submit

June 23, 2020

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

  • Hospital Admission

    Hospital Admission due to COPD exacerbation, Date and the event of Hospital admission will be obtained from clinical records of patients during visits 2 and 3.

    1 year

Secondary Outcomes (1)

  • COPD Exacerbation

    1 year

Study Arms (6)

very severe COPD

Patients diagnosed with COPD and FEV1 less than 30

Other: There is not intervention.

Severe COPD

Patients diagnosed with COPD and FEV1 less than 50

Other: There is not intervention.

Moderate COPD

Patients diagnosed with COPD and FEV1 less than 80

Other: There is not intervention.

Mild COPD

Patients diagnosed with COPD and FEV1 80 or more.

Other: There is not intervention.

CONTROL

Non-copd control group

Other: There is not intervention.

Exacerbated Patients

Patients 48 hours after hospital admission for COPD exacerbation.

Other: There is not intervention.

Interventions

There is not intervention.OTHER

There is not intervention

CONTROLExacerbated PatientsMild COPDModerate COPDSevere COPDvery severe COPD

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients selected from Pneumology outpatient clinics, and hospitalization from Hospital Universitario Marqués de Valdecilla a 3rd level hospital reference for a population of 250000.

You may qualify if:

  • Stable COPD (40 years or older with baseline post-bronchodilator forced expiratory volume in 1 s \[FEV1\]/forced vital capacity \[FVC\] ≤0.70) will be recruited during their regular follow-up.
  • Control group: age- and sex-matched volunteers without previous diagnosis of COPD or 6 other respiratory conditions, and with post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity \[FVC\]=0.70.
  • Exacerbated patients (patients 48h after being admited in Hospital due to severe COPD exacerbation.

You may not qualify if:

  • Patients with renal failure or other severe chronic or acute conditions.
  • Patients with exacerbations in the previous 6 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39005, Spain

RECRUITING

Related Publications (8)

  • Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med. 2017 Mar 1;195(5):557-582. doi: 10.1164/rccm.201701-0218PP.

    PMID: 28128970BACKGROUND

  • Habiballa L, Salmonowicz H, Passos JF. Mitochondria and cellular senescence: Implications for musculoskeletal ageing. Free Radic Biol Med. 2019 Feb 20;132:3-10. doi: 10.1016/j.freeradbiomed.2018.10.417. Epub 2018 Oct 15.

    PMID: 30336251BACKGROUND

  • Barreiro E, Gea J. Molecular and biological pathways of skeletal muscle dysfunction in chronic obstructive pulmonary disease. Chron Respir Dis. 2016 Aug;13(3):297-311. doi: 10.1177/1479972316642366. Epub 2016 Apr 6.

    PMID: 27056059BACKGROUND

  • Kang MJ, Shadel GS. A Mitochondrial Perspective of Chronic Obstructive Pulmonary Disease Pathogenesis. Tuberc Respir Dis (Seoul). 2016 Oct;79(4):207-213. doi: 10.4046/trd.2016.79.4.207. Epub 2016 Oct 5.

    PMID: 27790272BACKGROUND

  • Nam HS, Izumchenko E, Dasgupta S, Hoque MO. Mitochondria in chronic obstructive pulmonary disease and lung cancer: where are we now? Biomark Med. 2017 May;11(6):475-489. doi: 10.2217/bmm-2016-0373. Epub 2017 Jun 9.

    PMID: 28598223BACKGROUND

  • Amado CA, Martin-Audera P, Aguero J, Ferrer-Pargada D, Josa Laorden B, Boucle D, Berja A, Lavin BA, Guerra AR, Ghadban C, Munoz P, Garcia-Unzueta M. Alterations in circulating mitochondrial signals at hospital admission for COPD exacerbation. Chron Respir Dis. 2023 Jan-Dec;20:14799731231220058. doi: 10.1177/14799731231220058.

    PMID: 38112134DERIVED

  • Amado CA, Martin-Audera P, Aguero J, Lavin BA, Guerra AR, Boucle D, Ferrer-Pargada D, Berja A, Martin F, Casanova C, Garcia-Unzueta M. Circulating levels of mitochondrial oxidative stress-related peptides MOTS-c and Romo1 in stable COPD: A cross-sectional study. Front Med (Lausanne). 2023 Feb 8;10:1100211. doi: 10.3389/fmed.2023.1100211. eCollection 2023.

    PMID: 36844198DERIVED

  • Amado CA, Martin-Audera P, Aguero J, Lavin BA, Guerra AR, Munoz P, Berja A, Casanova C, Garcia-Unzueta M. Associations between serum mitokine levels and outcomes in stable COPD: an observational prospective study. Sci Rep. 2022 Oct 15;12(1):17315. doi: 10.1038/s41598-022-21757-5.

    PMID: 36243733DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Plasma.

Central Study Contacts

Carlos Antonio Amado Diago, PhD

CONTACT

0034676235753carlosantonio.amado@scsalud.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 26, 2020

Study Start

July 1, 2020

Primary Completion

November 1, 2020

Study Completion

June 1, 2021

Last Updated

June 26, 2020

Record last verified: 2020-06

Locations

ES(1)