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Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000 (MAESTRALE)

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ClinicalTrials.gov Identifier: NCT01651455
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : July 31, 2013
Sponsor:
Collaborator:
Medidata Solutions
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date July 25, 2012
First Posted Date July 27, 2012
Last Update Posted Date July 31, 2013
Study Start Date September 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 1, 2012)		 To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients [ Time Frame: 5 years ]
Original Primary Outcome Measures
 (submitted: July 26, 2012)		 To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients from the age of 10 to 15 treated before and after 2000 [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures
 (submitted: August 1, 2012)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: July 26, 2012)
  • To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients from the age 10 to 15 before and after 2000 [ 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000
Official Title Maintaining Lung Function in Cystic Fibrosis Patients: Evaluation and Comparison Between Two Decades in a Retrospective Monocentric Observational Study
Brief 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients affected with Pseudomonas A. living in the N-E area of Italy.
Condition Cystic Fibrosis
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 30, 2013)		 92
Original Estimated Enrollment
 (submitted: July 26, 2012)		 120
Actual Study Completion Date June 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01651455
Other Study ID Numbers MAESTRALE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Chiesi Farmaceutici S.p.A.
Study Sponsor Chiesi Farmaceutici S.p.A.
Collaborators Medidata Solutions
Investigators
Principal Investigator: Baroukh Maurice Assael, Professor U.O. Fibrosi Cistica Azienda Ospedaliera Verona
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date July 2013