The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00996424
• Date of registration: 15/10/2009
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Ghent
• Public title: The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function
• Scientific title: The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function.
• Date of first enrolment: January 2010
• Target sample size: 19
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00996424
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Belgium

Contacts

• Name: Sabine Van Daele, MD, PhD
• Affiliation: University Hospital, Ghent

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who can perform lung function tests and who can produce sputum (> 5 years of
age)

- (Fe)males between 6-64 years

Exclusion Criteria:

- Patients on the waiting lists for lung transplant.

- Pregnancy or breast feeding

- Patients can not take part in another 'inhalation'trial for Cystic Fibrosis



Age minimum: 6 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: normal saline

Drug: Acetylcysteine

Primary Outcome(s)

Changes in visco-elasticity and lung function. [Time Frame: after one dose of N-acetylcystein compared to normal saline]

Changes in visco-elasticity and lung function. [Time Frame: after one month of two doses per day of N-acetylcysteine compared to normal saline.]

Secondary ID(s)

2009/464

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

BVSM