Trial | NCT01377792  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    71
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.
Study Started
Mar 31
2009
Primary Completion
May 31
2011
Study Completion
Sep 30
2012
Last Update
Jan 30
2013
Estimate

Drug Hypertonic saline

comparison of different dosages of drug

5 ml Active Comparator

10 ml Active Comparator

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
No Results Posted