Back to resultsStudy of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Hypertonic saline
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring hypertonic saline, cystic fibrosis, pulmonary inflammation, pulmonary exacerbation
Eligibility 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
Sites / Locations
- Cystic Fibrosis Unit. Ramón y Cajal University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
5 ml
10 ml
Arm Description
Outcomes
Primary Outcome Measures
Free time, specified in days, of pulmonary exacerbation
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
Changes in inflammatory markers during the treatment
Measurement of inflammatory markers in induced sputum.
Quality of life
Measurement of quality of life of patients during treatment by CFQ-R test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01377792
Brief Title
Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis
Official Title
Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adelaida Lamas Ferreiro
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
hypertonic saline, cystic fibrosis, pulmonary inflammation, pulmonary exacerbation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5 ml
Arm Type
Active Comparator
Arm Title
10 ml
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hypertonic saline
Intervention Description
comparison of different dosages of drug
Primary Outcome Measure Information:
Title
Free time, specified in days, of pulmonary exacerbation
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in lung function test measured by spirometry
Time Frame
12 months
Title
Changes in inflammatory markers during the treatment
Description
Measurement of inflammatory markers in induced sputum.
Time Frame
12 months
Title
Quality of life
Description
Measurement of quality of life of patients during treatment by CFQ-R test
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaida Lamas, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cystic Fibrosis Unit. Ramón y Cajal University Hospital
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis
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