Cystic FibrosisMAESTRALENCT01651455
Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000
An observational study of Cystic Fibrosis, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
Trial summary
The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Jun 2013
- 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients affected with Pseudomonas A. living in the N-E area of Italy.
Who may be able to join
- Patients with Cystic Fibrosis diagnosed with neo-natal screening
- Patients born between 01/01/1979 and 12/31/1984 (Cohort 1)and patients born between 01/01/1991 and 12/31/1996 (Cohort 2)
- Patients with at least 2 FEV1 yearly measurements from the age of 10 to 15
Who cannot join
- Patients with malignant tumor
- Patients with meconium ileus
- Patients with transplantation (pneumectomy or lobectomy)
- Patients involved in any other clinical trial
- Patients moved to another Clinical Center
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maintaining Lung Function in Cystic Fibrosis Patients: Evaluation and Comparison Between Two Decades in a Retrospective Monocentric Observational Study
The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.
Read the detailed description
The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in terms of FEV1 maintenance from the age of 10 to 15 before and after 2000.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Pseudomonas Aeruginosa
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
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 |
|---|---|---|
| Cohort first decade | Patients born between 01/01/1979 and 12/31/1984 | |
| Cohort second decade | Patients born between 01/01/1991 and 12/31/1996 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients
Measured: 5 years
Secondary outcomes (3)
To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients
Measured: 5 years
To evaluate the number of patients with Pseudomonas Aeruginosa infection during observational period
Measured: 5 years
To describe length of time without Pseudomonas A. infection in non-colonized patients during observational period.
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 posted27 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medidata Solutions
- Responsible party
- Sponsor
- Investigators
- Baroukh Maurice Assael, Professor, Principal investigator, U.O. Fibrosi Cistica Azienda Ospedaliera Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651455
- Sponsor's protocol ID
- MAESTRALE
- Acronym
- MAESTRALE
- Status last verified
- Jul 2013
- First submitted
- 25 Jul 2012
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Lung Function in Cystic Fibrosis Patients: Evaluation and Comparison Between Two Decades in a Retrospective Monocentric Observational Study
- ClinicalTrials.gov ID
- NCT01651455
- Acronym / sponsor ID
- MAESTRALE / MAESTRALE
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Pseudomonas Aeruginosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- Medidata Solutions
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Jul 2012 (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 purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.
Detailed description
The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in terms of FEV1 maintenance from the age of 10 to 15 before and after 2000.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort first decade | – | –Patients born between 01/01/1979 and 12/31/1984 |
| Cohort second decade | – | –Patients born between 01/01/1991 and 12/31/1996 |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients affected with Pseudomonas A. living in the N-E area of Italy.
Key inclusion criteria (3 listed)
- Patients with Cystic Fibrosis diagnosed with neo-natal screening
- Patients born between 01/01/1979 and 12/31/1984 (Cohort 1)and patients born between 01/01/1991 and 12/31/1996 (Cohort 2)
- Patients with at least 2 FEV1 yearly measurements from the age of 10 to 15
Key exclusion criteria (5 listed)
- Patients with malignant tumor
- Patients with meconium ileus
- Patients with transplantation (pneumectomy or lobectomy)
- Patients involved in any other clinical trial
- Patients moved to another Clinical Center
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 describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients
Time frame: 5 years
3 secondary outcomes
To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients
Time frame: 5 years
To evaluate the number of patients with Pseudomonas Aeruginosa infection during observational period
Time frame: 5 years
To describe length of time without Pseudomonas A. infection in non-colonized patients during observational period.
Time frame: 5 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 31 Jul 2013.
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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.
Baroukh Maurice Assael, Professor principal investigator
U.O. Fibrosi Cistica Azienda Ospedaliera Verona
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 Cystic Fibrosis, run by Chiesi Farmaceutici S.p.A. at 1 site in Italy.
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 5 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 31 Jul 2013. 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 Italy. 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?
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?
To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients (time frame: 5 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 31 Jul 2013.