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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377792
• Other study ID #: SSH-FQ1
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2011
• Last updated: January 29, 2013
• Start date: March 2009
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Hypertonic saline
comparison of different dosages of drug

Locations

Country	Name	City	State
Spain	Cystic Fibrosis Unit. Ramón y Cajal University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Adelaida Lamas Ferreiro

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in lung function test measured by spirometry		12 months	No
Secondary	Changes in inflammatory markers during the treatment	Measurement of inflammatory markers in induced sputum.	12 months	No
Secondary	Quality of life	Measurement of quality of life of patients during treatment by CFQ-R test	12 months	No