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

January 29, 2013 updated by: Adelaida Lamas Ferreiro

Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Cystic Fibrosis Unit. Ramón y Cajal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in lung function test measured by spirometry
Time Frame: 12 months
12 months
Changes in inflammatory markers during the treatment
Time Frame: 12 months
Measurement of inflammatory markers in induced sputum.
12 months
Quality of life
Time Frame: 12 months
Measurement of quality of life of patients during treatment by CFQ-R test
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adelaida Lamas Ferreiro

Investigators

  • Principal Investigator: Adelaida Lamas, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 21, 2011

Study Record Updates

Last Update Posted (Estimate)

January 30, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSH-FQ1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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