Alpha-1 Antitrypsin DeficiencyAATDNCT02547532
Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
An observational study of Alpha-1 Antitrypsin Deficiency, run by Fondazione Salvatore Maugeri.
Trial summary
In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alpha-1 Antitrypsin Deficiency
- What is being tested?
- collection of sputum
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Apr 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal volunterrs Patients with COPD without AATD Patients with COPD and with AATD
Who may be able to join
- diagnosis of COPD and a clinical stable condition, i.e. at least three months from the last AECOPD and/or antibiotic treatment.
- For patients with AATD this condition will be diagnosed by laboratory tests showing low levels of AAT and genotyping of AATD-related genes.
- . Exclusion Criteria:
- The presence of important co-morbidities (diabetes, systemic or organ infections, immunodeficiency, tumors, moderate-severe heart failure) will be considered as exclusion criteria.
Who cannot join
None listed.
About this study
In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. These quantitative data obtained from sputum will be analyzed in the context of the clinical and physiological parameters of the patients.
- Conditions
- Alpha-1 Antitrypsin Deficiency
- Being tested
- collection of sputum
- Keywords
- COPD, alpha-1 antitrypsin deficiency, microbioma
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of sputumOther
| Study group | Role | What they receive |
|---|---|---|
| usual COPD | Patients meeting the diagnostic criteria for COPD and without AATD Receives: Other: collection of sputum | |
| normal smokers | subjects with a history of smoking, without symptoms, without AATD and with normal lung function Receives: Other: collection of sputum | |
| normal non smokers | subjects without a history of smoking, without symptoms, without AATD and with normal lung function Receives: Other: collection of sputum | |
| AATD not treated | patients with COPD, with AATD and not on augmentation therapy for AATD Receives: Other: collection of sputum | |
| AATD treated | patients with COPD, with AATD on augmentation therapy for AATD Receives: Other: collection of sputum |
What is being measured
The primary outcome is the main question the study is designed to answer.
composition of microbioma in sputa
Measured: 2 years
Secondary outcomes (1)
correlation with clinical and physiological parameters
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha-1 Antitrypsin DeficiencyStudies 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Grifols Biologicals, LLC
- Responsible party
- Principal investigator, Bruno Balbi, Fondazione Salvatore Maugeri
- Investigators
- Pantaleo Giannuzzi, M.D., Study director, Fondazione Salvatore Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547532
- Sponsor's protocol ID
- Fsalvatoremaugeri
- Acronym
- AATD
- Status last verified
- Jul 2018
- First submitted
- 9 Sep 2015
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
- ClinicalTrials.gov ID
- NCT02547532
- Acronym / sponsor ID
- AATD / Fsalvatoremaugeri
- Conditions
- Alpha-1 Antitrypsin Deficiency
- Keywords
- COPD, alpha-1 antitrypsin deficiency, microbioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Grifols Biologicals, LLC
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 11 Sep 2015 (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.
In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. These quantitative data obtained from sputum will be analyzed in the context of the clinical and physiological parameters of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| usual COPD | – | Other: collection of sputumPatients meeting the diagnostic criteria for COPD and without AATD |
| normal smokers | – | Other: collection of sputumsubjects with a history of smoking, without symptoms, without AATD and with normal lung function |
| normal non smokers | – | Other: collection of sputumsubjects without a history of smoking, without symptoms, without AATD and with normal lung function |
| AATD not treated | – | Other: collection of sputumpatients with COPD, with AATD and not on augmentation therapy for AATD |
| AATD treated | – | Other: collection of sputumpatients with COPD, with AATD on augmentation therapy for AATD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal volunterrs Patients with COPD without AATD Patients with COPD and with AATD
Key inclusion criteria (4 listed)
- diagnosis of COPD and a clinical stable condition, i.e. at least three months from the last AECOPD and/or antibiotic treatment.
- For patients with AATD this condition will be diagnosed by laboratory tests showing low levels of AAT and genotyping of AATD-related genes.
- The presence of important co-morbidities (diabetes, systemic or organ infections, immunodeficiency, tumors, moderate-severe heart failure) will be considered as exclusion criteria.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of sputum | Other | AATD not treated, AATD treated, normal non smokers, normal smokers, usual COPD |
Primary outcome
composition of microbioma in sputa
Time frame: 2 years
1 secondary outcome
correlation with clinical and physiological parameters
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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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.
Pantaleo Giannuzzi, M.D. study director
Fondazione Salvatore Maugeri
Questions about this trial
What is this clinical trial studying?
An observational study of Alpha-1 Antitrypsin Deficiency, run by Fondazione Salvatore Maugeri.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composition of microbioma in sputa (time frame: 2 years). 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 1 Aug 2018.