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Completed

NCT Number: NCT01377792

Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis

A phase IV clinical trial, multicentric (3 Hospitals in Madrid) controlled, prospective, open and randomized of long-term treatment with hypertonic saline in cystic fibrosis patients. The purpose of this study is to verify if the long term inhalation (48 weeks) of major volume (10 ml) increases the free time without pulmonary exacerbation, and if this increase is superior to the obtained with the inhalation of the standard volume (5 ml) that has been advocated.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Infections Lung Diseases Pancreatic Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cystic Fibrosis Unit. Ramón y Cajal University Hospital

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of Cystic fibrosis
  • Over 6 years old
  • FEV1 over than 30%
  • Must be able to perform a spirometry
  • Must be able to perform induced sputum
  • Must tolerate the maximum dose of 10 ml hypertonic saline
  • No oral neither intravenous treatment within the previous 2 weeks before the beginning of the study
  • No treatment with hypertonic saline in the 2 weeks before

Exclusion criteria

  • No clinical diagnosis of Cystic Fibrosis
  • No tolerance of 10 ml of hypertonic saline
  • Positive pregnancy test
  • No tolerance of Beta2-agonist
  • Treatment with corticosteroids
  • FEV1 < 30%
  • Liver and/or lung transplantation
  • Oxygen treatment
  • Hospital admission within the 4 previous weeks
  • Oral or intravenous antibiotic treatment within the 2 previous weeks
  • Smokers
  • Pulmonary colonisation with Burkholderia cepacia complex

Treatment and study plan

Hypertonic saline

Drug

comparison of different dosages of drug

Primary outcomes

  1. Free time, specified in days, of pulmonary exacerbation

    Time frame: 12 months

    Exact number of days, along 48 weeks of tretment with hypertonic saline, in wich the patient is free of pulmonary excaerbation symptoms and does not need antibiotics.

Secondary outcomes

  1. Changes in lung function test measured by spirometry

    Time frame: 12 months

  2. Changes in inflammatory markers during the treatment

    Time frame: 12 months

    Measurement of inflammatory markers in induced sputum.

  3. Quality of life

    Time frame: 12 months

    Measurement of quality of life of patients during treatment by CFQ-R test

Sponsors and collaborators

Lead sponsor

Adelaida Lamas Ferreiro

Other

Registry information

Official study title

Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jun 21, 2011
Registry last updated
Jan 30, 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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