NCT01122758

Brief Summary

The research project CHAIN (COPD Assessment History in Spain): "A Multidimensional Study on the Evolution of Chronic Obstructive Pulmonary Disease (COPD)is a multicentre, observational study conducted in several areas of Spain aimed to better define COPD natural history and its phenotypes

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
2,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

December 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

4.1 years

First QC Date

May 11, 2010

Last Update Submit

November 27, 2012

Conditions

COPD

Keywords

CohortCOPDNatural historyPhenotypingSmoking

Outcome Measures

Primary Outcomes (1)

  • To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD

    5 years

Secondary Outcomes (1)

  • - Progression of the disease by degree of severity. - Effect of treatment on disease progression and variability of response according to phenotypes. - Geographical differences. - The impact of exacerbations. - The importance of comorbidities and

    5 years

Study Arms (2)

COPD cohort

Inclusion criteria: * Patients ≥ 35 years. * Diagnosis of COPD (GOLD PBD FEV1/FVC ratio \<0.70). * Being in a stable phase of disease (8 weeks without exacerbation). * Cummulative smoking ≥ 10 pack-years. * Absence of asthma or other chronic respiratory disease that justify the ventilatory disorder (although a history of asthma is not an exclusion criteria); * Absence of malignancy or very serious comorbidities that would prevent study completion. Exclusion criteria: * Patients \<35 years. * Recent exacerbation (\<8 weeks). * Not giving written informed consent. * Presence of asthma or other chronic respiratory disease justifying the ventilatory disorder, * Diffuse bronchiectasis not associated with COPD. * Presence of malignancy or very serious comorbidities that would prevent study completion. * Difficulty to perform appropriate follow-up.

Control cohort

Inclusion criteria: * Patients ≥ 35 years. * Absence of diagnosis of COPD (GOLD PBD FEV1/FVC ratio \>=0.70). * Cummulative smoking ≥ 10 pack-years. * Absence of asthma or other chronic respiratory disease that justify the ventilatory disorder (although a history of asthma is not an exclusion criteria); * Absence of malignancy or very serious comorbidities that would prevent study completion. Exclusion criteria: * Patients \<35 years. * Not giving written informed consent. * Presence of asthma or other chronic respiratory disease justifying the ventilatory disorder, * Diffuse bronchiectasis not associated with COPD. * Presence of malignancy or very serious comorbidities that would prevent study completion. * Difficulty to perform appropriate follow-up.

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be selected from the outpatient clinics, pulmonary function labs, and / or pulmonology wards of each participating center

You may qualify if:

  • Patients ≥ 35 years.
  • Diagnosis of COPD (GOLD PBD FEV1/FVC ratio \<0.70).
  • Being in a stable phase of disease (8 weeks without exacerbation).
  • Cummulative smoking ≥ 10 pack-years.

You may not qualify if:

  • Absence of malignancy or very serious comorbidities that would prevent study completion.
  • Patients \<35 years.
  • Recent exacerbation (\<8 weeks).
  • Not giving written informed consent.
  • Presence of asthma or other chronic respiratory disease justifying the ventilatory disorder,
  • Diffuse bronchiectasis not associated with COPD.
  • Presence of malignancy or very serious comorbidities that would prevent study completion.
  • Difficulty to perform appropriate follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ciro Casanova

Santa Cruz de Tenerife, Canary Islands, Spain

RECRUITING

40-50 additional centres throughout Spain

Bunyola, 07110, Spain

RECRUITING

Related Publications (8)

  • Casanova C, Gonzalez-Davila E, de Torres JP, Cabrera C, Cosio BG, O'Donnel DE, Martinez-Gonzalez C, Solanes I, Fuster A, Gotera C, Marin A, Amado C, Iscar M, Marin JM, Neder JA, Feu N, Soriano JB, Lopez-Campos JL, Divo M, Peces-Barba G, Celli BR. Lung Diffusing Capacity Improves the Prognostic Validity of the GOLD Spirometric Staging in COPD. Arch Bronconeumol. 2026 Jan;62(1):20-27. doi: 10.1016/j.arbres.2025.05.004. Epub 2025 May 16. English, Spanish.

    PMID: 40447521DERIVED

  • Casanova C, Gonzalez-Davila E, Martinez-Gonzalez C, Cosio BG, Fuster A, Feu N, Solanes I, Cabrera C, Marin JM, Balcells E, Peces-Barba G, de Torres JP, Marin-Oto M, Calle M, Golpe R, Ojeda E, Divo M, Pinto-Plata V, Amado C, Lopez-Campos JL, Celli BR. Natural Course of the Diffusing Capacity of the Lungs for Carbon Monoxide in COPD: Importance of Sex. Chest. 2021 Aug;160(2):481-490. doi: 10.1016/j.chest.2021.03.069. Epub 2021 Apr 18.

    PMID: 33878339DERIVED

  • Calle Rubio M, Rodriguez Hermosa JL, de Torres JP, Marin JM, Martinez-Gonzalez C, Fuster A, Cosio BG, Peces-Barba G, Solanes I, Feu-Collado N, Lopez-Campos JL, Casanova C; CHAIN Study Investigators. COPD Clinical Control: predictors and long-term follow-up of the CHAIN cohort. Respir Res. 2021 Feb 4;22(1):36. doi: 10.1186/s12931-021-01633-y.

    PMID: 33541356DERIVED

  • Soriano JB, Hahsler M, Soriano C, Martinez C, de-Torres JP, Marin JM, de Lucas P, Cosio BG, Fuster A, Casanova C; CHAIN investigators. Temporal transitions in COPD severity stages within the GOLD 2017 classification system. Respir Med. 2018 Sep;142:81-85. doi: 10.1016/j.rmed.2018.07.019. Epub 2018 Aug 3.

    PMID: 30170807DERIVED

  • Martinez-Gonzalez C, Casanova C, de-Torres JP, Marin JM, de Lucas P, Fuster A, Cosio BG, Calle M, Peces-Barba G, Solanes I, Aguero R, Feu-Collado N, Alfageme I, Romero Plaza A, Balcells E, de Diego A, Marin Royo M, Moreno A, Llunell Casanovas A, Galdiz JB, Golpe R, Lacarcel Bautista C, Cabrera C, Marin A, Soriano JB, Lopez-Campos JL; CHAIN Study Investigators. Changes and Clinical Consequences of Smoking Cessation in Patients With COPD: A Prospective Analysis From the CHAIN Cohort. Chest. 2018 Aug;154(2):274-285. doi: 10.1016/j.chest.2018.02.007. Epub 2018 Feb 22.

    PMID: 29476876DERIVED

  • Cosio BG, Soriano JB, Lopez-Campos JL, Calle-Rubio M, Soler-Cataluna JJ, de-Torres JP, Marin JM, Martinez-Gonzalez C, de Lucas P, Mir I, Peces-Barba G, Feu-Collado N, Solanes I, Alfageme I, Casanova C; CHAIN Study. Defining the Asthma-COPD Overlap Syndrome in a COPD Cohort. Chest. 2016 Jan;149(1):45-52. doi: 10.1378/chest.15-1055. Epub 2016 Jan 6.

    PMID: 26291753DERIVED

  • Casanova C, Marin JM, Martinez-Gonzalez C, de Lucas-Ramos P, Mir-Viladrich I, Cosio B, Peces-Barba G, Solanes-Garcia I, Aguero R, Feu-Collado N, Calle-Rubio M, Alfageme I, de Diego-Damia A, Irigaray R, Marin M, Balcells E, Llunell A, Galdiz JB, Golpe R, Lacarcel C, Cabrera C, Marin A, Soriano JB, Lopez-Campos JL, Soler-Cataluna JJ, de-Torres JP; COPD History Assessment in Spain (CHAIN) Cohort. Differential Effect of Modified Medical Research Council Dyspnea, COPD Assessment Test, and Clinical COPD Questionnaire for Symptoms Evaluation Within the New GOLD Staging and Mortality in COPD. Chest. 2015 Jul;148(1):159-168. doi: 10.1378/chest.14-2449.

    PMID: 25612228DERIVED

  • de Torres JP, Marin JM, Martinez-Gonzalez C, de Lucas-Ramos P, Mir-Viladrich I, Cosio B, Peces-Barba G, Calle-Rubio M, Solanes-Garcia I, Aguero Balbin R, de Diego-Damia A, Feu-Collado N, Alfageme Michavila I, Irigaray R, Balcells E, Llunell Casanovas A, Galdiz Iturri JB, Marin Royo M, Soler-Cataluna JJ, Lopez-Campos JL, Soriano JB, Casanova C; COPD History Assessment in Spain (CHAIN) Cohort*. Clinical application of the COPD assessment test: longitudinal data from the COPD History Assessment in Spain (CHAIN) cohort. Chest. 2014 Jul;146(1):111-122. doi: 10.1378/chest.13-2246.

    PMID: 24522636DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

complete blood and serum samples

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveSmoking

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Ciro Casanova, MD

    Hospital Nuestra Señora de la Candelaria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ciro Casanova, MD

CONTACT

casanovaciro@gmail.com

Joan B Soriano, MD

CONTACT

34971148437jbsoriano@caubet-cimera.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 13, 2010

Study Start

December 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2016

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations

ES(2)