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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adelaida Lamas Ferreiro, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT01377792
First received: May 9, 2011
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Changes in inflammatory markers during the treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measurement of inflammatory markers in induced sputum.

  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377792

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

No publications provided

Responsible Party: Adelaida Lamas Ferreiro, Dra.Adelaida Lamas Ferreiro, Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT01377792     History of Changes
Other Study ID Numbers: SSH-FQ1
Study First Received: May 9, 2011
Last Updated: January 29, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013