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

NCT01377792 | Completed Phase 4 DMC

• 1 other identifier: SSH-FQ1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

hypertonic saline; cystic fibrosis; pulmonary inflammation; pulmonary exacerbation

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (3)

• Changes in lung function test measured by spirometry

  12 months

• Changes in inflammatory markers during the treatment

  12 months

• Quality of life

  12 months

Study Arms (2)

5 ml

ACTIVE COMPARATOR

Drug: Hypertonic saline

10 ml

ACTIVE COMPARATOR

Drug: Hypertonic saline

Interventions

Hypertonic saline DRUG

comparison of different dosages of drug

10 ml; 5 ml

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adelaida Lamas Ferreiro: lead

Study Sites (1)

Cystic Fibrosis Unit. Ramón y Cajal University Hospital

Madrid, Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pneumonia

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Adelaida Lamas, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dra.Adelaida Lamas Ferreiro

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: June 21, 2011
• Study Start: March 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2012
• Last Updated: January 30, 2013

Record last verified: 2013-01

Locations

ES (1)