COPDCHAINNCT01122758
Chronic Obstructive Pulmonary Disease (COPD) History Assessment In SpaiN (CHAIN)
An observational study of COPD, run by Cimera at 2 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 2,400 participants
- Where
- 2 sitesSpain
- Study dates
- Dec 2009to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be selected from the outpatient clinics, pulmonary function labs, and / or pulmonology wards of each participating center
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Ciro Casanova, MD contact
Spain2 sites, 2 recruiting
- Recruiting
40-50 additional centres throughout Spain
Bunyola, 07110
Joan B Soriano, 724, 34971148437, jbsoriano@caubet-cimera.es
724 724 724, 724, 34971148437, jbsoriano@caubet-cimera.es
- Recruiting
Ciro Casanova
Santa Cruz de Tenerife, Canary Islands
Ciro Casanova, casanovaciro@gmail.com
About this study
Official title: (COPD History Assessment In SpaiN): "Estudio Sobre la Evolución Multidimensional de la Enfermedad Pulmonar Obstructiva Crónica (EPOC)".
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
Read the detailed description
Observational studies are needed to ascertain the natural history and progression of COPD, and to better define its phenotypes. These two aspects are considered fundamental to a proper evaluation of current (and future) COPD treatment options, and it could possibly justify the limited impact of recent major drug trials.
Currently, there remain gaps in the natural history of patients with COPD. Most data are from analysis of mild COPD patients or smokers, usually measuring only fall in FEV1, and both have significant limitations in design and interpretation.
Studies in more severe patients with COPD have also been conducted mainly by studying lung function, possibly influenced by the recommendations of current guidelines for disease management. In recent years, we have more longitudinal data on changes in exercise capacity, imaging, and biomarkers, among other variables of interest, but our knowledge is yet partial.
The research project CHAIN (COPD Assessment History in Spain): "A Multidimensional Study on the Evolution of Chronic Obstructive Pulmonary Disease (COPD) is a multicenter observational study that will follow prospectively two cohorts: a) a COPD group active or former smokers (COPD cohort) and b) a group of active smokers or former smokers without COPD (control cohort). Both cohorts will be followed up for a period of at least 5 years, with visits every 12 months (and phone controls at least every 6 months). We will try to extend the monitoring of the cohort up to 10 years. CHAIN is supported by the PII of COPD SEPAR
- Conditions
- COPD
- Keywords
- Cohort, COPD, Natural history, Phenotyping, Smoking
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2014 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cimera
- Sponsor type
- Research network
- Investigators
- Ciro Casanova, MD, Principal investigator, Hospital Nuestra Señora de la Candelaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122758
- Sponsor's protocol ID
- CHAIN
- Other IDs
- IB1323/10PI
- Acronym
- CHAIN
- Status last verified
- Nov 2012
- First submitted
- 11 May 2010
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40447521Casanova 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.
PubMed 33878339Calle 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.
PubMed 33541356Soriano 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.
PubMed 30170807Martinez-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.
PubMed 29476876Cosio 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.
PubMed 26291753Casanova 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.
PubMed 25612228de 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.
PubMed 24522636
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (COPD History Assessment In SpaiN): "Estudio Sobre la Evolución Multidimensional de la Enfermedad Pulmonar Obstructiva Crónica (EPOC)".
- ClinicalTrials.gov ID
- NCT01122758
- Acronym / sponsor ID
- CHAIN / CHAIN
- Conditions
- COPD
- Keywords
- Cohort, COPD, Natural history, Phenotyping, Smoking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- CimeraResearch network
- Study start
- Dec 2009
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Observational studies are needed to ascertain the natural history and progression of COPD, and to better define its phenotypes. These two aspects are considered fundamental to a proper evaluation of current (and future) COPD treatment options, and it could possibly justify the limited impact of recent major drug trials.
Currently, there remain gaps in the natural history of patients with COPD. Most data are from analysis of mild COPD patients or smokers, usually measuring only fall in FEV1, and both have significant limitations in design and interpretation.
Studies in more severe patients with COPD have also been conducted mainly by studying lung function, possibly influenced by the recommendations of current guidelines for disease management. In recent years, we have more longitudinal data on changes in exercise capacity, imaging, and biomarkers, among other variables of interest, but our knowledge is yet partial.
The research project CHAIN (COPD Assessment History in Spain): "A Multidimensional Study on the Evolution of Chronic Obstructive Pulmonary Disease (COPD) is a multicenter observational study that will follow prospectively two cohorts: a) a COPD group active or former smokers (COPD cohort) and b) a group of active smokers or former smokers without COPD (control cohort). Both cohorts will be followed up for a period of at least 5 years, with visits every 12 months (and phone controls at least every 6 months). We will try to extend the monitoring of the cohort up to 10 years. CHAIN is supported by the PII of COPD SEPAR
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from the outpatient clinics, pulmonary function labs, and / or pulmonology wards of each participating center
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD
Time frame: 5 years
1 secondary outcome
- 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
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
- Derived from this study: PubMed 40447521Casanova 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.
- Derived from this study: PubMed 33878339Casanova 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.
- Derived from this study: PubMed 33541356Calle 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.
- Derived from this study: PubMed 30170807Soriano 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.
- Derived from this study: PubMed 29476876Martinez-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.
- Derived from this study: PubMed 26291753Cosio 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.
- Derived from this study: PubMed 25612228Casanova 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.
- Derived from this study: PubMed 24522636de 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.
- SEPAR-Sociedad Española de Neumología y Cirugía TorácicaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciro Casanova, MD contact
Ciro Casanova, MD principal investigator
Hospital Nuestra Señora de la Candelaria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Cimera at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ciro Casanova, MD (casanovaciro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To better determine COPD with a multidimensional assessment and the phenotypic progression of COPD (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01122758, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012.