Chronic Obstructive Pulmonary DiseaseCOPDTESTONCT02824809
Association Between Testosterone Levels and COPD Severity
An observational study of Chronic Obstructive Pulmonary Disease and Hypogonadism, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The Aims of the study are estimate the association between the severity of COPD and free testosterone level and the prevalence of hypogonadism in adult men with stable COPD Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hypogonadism
- How many people
- 150 participants
- Where
- 1 siteArgentina
- Study dates
- Jun 2016to Mar 2017
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with stable COPD that consult in a tertiary academic teaching hospital in Buenos Aires, Argentina
Who may be able to join
- Adults Men ≥ 45 years
- COPD defined according to clinical diagnosis and spirometry American thoracic society ( ATS) criteria
- Stable COPD without recent acute exacerbation (less than 2 weeks)
Who cannot join
- Refusal to participate or informed consent process
- Those who are under treatment with testosterone replacement or anti-androgens
- Comorbidities: Cirrhosis, Alcoholism, cryptorchidism, panhypopituitarism, Pituitary adenoma.
- Orchiectomy
- Systemic glucocorticoids (equivalent dose ≥ 4 mg of prednisone in the last 3 weeks).
- Relative and absolute contraindications for spirometry.
Trial locations and contacts
1 site in 1 country.
Joaquin Maritano Furcada, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires
Horacio M Castro, MD, 54-11-67622134, matias.castro@hospitalitaliano.org.ar
About this study
Official title: Association Between Testosterone Levels and COPD Severity Measured by BODE Index in Men
The Aims of the study are estimate the association between the severity of COPD and free testosterone level and the prevalence of hypogonadism in adult men with stable COPD
- Keywords
- hypogonadism, Chronic Obstructive Pulmonary Disease, Severity of Illness Index, Testosterone
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypogonadism
What is being measured
The primary outcome is the main question the study is designed to answer.
Free testosterone Level
Measured: One day
Secondary outcomes (1)
Prevalence of Hypogonadism
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Asociacion Argentina Medicina Respiratoria (AAMR)
- Responsible party
- Principal investigator, Horacio Matias Castro, Hospital Italiano de Buenos Aires
- Investigators
- Horacio M Castro, MD, Principal investigator, HIBA, Buenos Aires Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824809
- Sponsor's protocol ID
- 2413
- Acronym
- COPDTESTO
- Status last verified
- Jul 2016
- First submitted
- 2 Jul 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Testosterone Levels and COPD Severity Measured by BODE Index in Men
- ClinicalTrials.gov ID
- NCT02824809
- Acronym / sponsor ID
- COPDTESTO / 2413
- Keywords
- hypogonadism, Chronic Obstructive Pulmonary Disease, Severity of Illness Index, Testosterone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Asociacion Argentina Medicina Respiratoria (AAMR)
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 7 Jul 2016 (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 Aims of the study are estimate the association between the severity of COPD and free testosterone level and the prevalence of hypogonadism in adult men with stable COPD
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with stable COPD that consult in a tertiary academic teaching hospital in Buenos Aires, Argentina
Key inclusion criteria (3 listed)
- Adults Men ≥ 45 years
- COPD defined according to clinical diagnosis and spirometry American thoracic society ( ATS) criteria
- Stable COPD without recent acute exacerbation (less than 2 weeks)
Key exclusion criteria (6 listed)
- Refusal to participate or informed consent process
- Those who are under treatment with testosterone replacement or anti-androgens
- Comorbidities: Cirrhosis, Alcoholism, cryptorchidism, panhypopituitarism, Pituitary adenoma.
- Orchiectomy
- Systemic glucocorticoids (equivalent dose ≥ 4 mg of prednisone in the last 3 weeks).
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
Free testosterone Level
Time frame: One day
1 secondary outcome
Prevalence of Hypogonadism
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Joaquin Maritano Furcada, MD contact
Horacio M Castro, MD principal investigator
HIBA, Buenos Aires Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Hypogonadism, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 3 inclusion and 6 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 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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 Horacio M Castro, MD (1567622134 ext. 054011, matias.castro@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free testosterone Level (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2016.