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Completed

NCT Number: NCT01651455

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

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.

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Key information

Conditions

Cystic Fibrosis Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Gram-Negative Bacterial Infections Infant, Newborn, Diseases Infections Lung Diseases Pancreatic Diseases Pseudomonas Infections Respiratory Tract Diseases

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

U.O. Azienda Ospedaliera

Verona, Veneto, 37126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients

    Time frame: 5 years

Secondary outcomes

  1. To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients

    Time frame: 5 years

  2. To evaluate the number of patients with Pseudomonas Aeruginosa infection during observational period

    Time frame: 5 years

  3. To describe length of time without Pseudomonas A. infection in non-colonized patients during observational period.

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Collaborators

  • Medidata Solutions

Registry information

Official study title

Maintaining Lung Function in Cystic Fibrosis Patients: Evaluation and Comparison Between Two Decades in a Retrospective Monocentric Observational Study

Acronym: MAESTRALE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 27, 2012
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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