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

This study has been completed.
Information provided by (Responsible Party):
Adelaida Lamas Ferreiro, Hospital Universitario Ramon y Cajal Identifier:
First received: May 9, 2011
Last updated: January 29, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Cystic Fibrosis
Drug: Hypertonic saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis

Resource links provided by NLM:

Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Changes in lung function test measured by spirometry [ Time Frame: 12 months ]
  • Changes in inflammatory markers during the treatment [ Time Frame: 12 months ]
    Measurement of inflammatory markers in induced sputum.

  • Quality of life [ Time Frame: 12 months ]
    Measurement of quality of life of patients during treatment by CFQ-R test

Enrollment: 71
Study Start Date: March 2009
Study Completion Date: September 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5 ml Drug: Hypertonic saline
comparison of different dosages of drug
Active Comparator: 10 ml Drug: Hypertonic saline
comparison of different dosages of drug


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01377792

Cystic Fibrosis Unit. Ramón y Cajal University Hospital
Madrid, Spain, 28034
Sponsors and Collaborators
Adelaida Lamas Ferreiro
Principal Investigator: Adelaida Lamas, MD
  More Information

Responsible Party: Adelaida Lamas Ferreiro, Dra.Adelaida Lamas Ferreiro, Hospital Universitario Ramon y Cajal Identifier: NCT01377792     History of Changes
Other Study ID Numbers: SSH-FQ1
Study First Received: May 9, 2011
Last Updated: January 29, 2013

Keywords provided by Hospital Universitario Ramon y Cajal:
hypertonic saline
cystic fibrosis
pulmonary inflammation
pulmonary exacerbation

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases processed this record on April 21, 2017