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

This study has been terminated.
(Insufficient recruitment.)
Sponsor:
Collaborator:
BVSM
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00996424
First received: October 15, 2009
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

Inhalation treatment with mucolytics is one of the cornerstones of CF treatment for respiratory problems.

The efficacy of inhalation treatment with recombinant DNAse and hypertonic saline is well established. The North American CF foundation reported that there is insufficient evidence for or against the chronic use of inhaled N-Acetylcysteine (NAC) to improve lung function and reduce exacerbations .

In vitro tests proved the positive effect of NAC on sputum rheology . Evidence based research however on the in vivo effect of NAC on visco-elasticity and lung function is rare. There are only three randomized controlled clinical trials on nebulised NAC, none of them showing a statistically significant or clinically relevant beneficial effect. Nevertheless at least in Europe for many years inhalation treatment with NAC is advised. Because of the disgusting sulphur odour, many patients are reluctant to use this inhalation medication.

We intend to start an open placebo controlled in vivo cross-over study to evaluate the effect of Acetyl cysteine compared to normal saline on the sputum visco-elasticity and on the short term effect on lung function.

Sputum producing CF-patients, able to perform lung function tests will be enrolled.

Sputum viscoelasticity will be measured by a controlled-stress rheometer (AR 1000-N; TA-Instruments, Ghent, Belgium) at 20° C, using a cone-plate geometry 8.

Lung function measurement (FVC, FEV1, FEF 25-75) will be done in a Masterlab body plethysmograph (Jaeger®) Sputum samples will be collected before lung function test on a regular control visit. Three ml of NAC or 4 ml of normal saline will be inhaled, afterwards a second sputum sample will be collected and a control lung function test will be performed. Visco-elasticity measurements will be done on sputum samples before and after inhalation of NAC or normal saline. Patients will continue to inhale N-acetylcysteine or normal saline two times per day for one month. After one month a control lung function and a third sputum sample will be collected, visco-elasticity and lung function will be measured and compared to the initial values in both groups and between groups. After a wash-out period of normal saline inhalations during 2 weeks in both groups, patients in the initial control group will be asked to switch to inhalation of 3 ml of NAC two times per day and the former NAC group will continue to inhale two times 4 ml of normal saline during four weeks. After one month the same measurements of visco-elasticity and lung function tests will be done.


Condition Intervention Phase
Cystic Fibrosis
Drug: Acetylcysteine
Drug: normal saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Changes in visco-elasticity and lung function. [ Time Frame: after one dose of N-acetylcystein compared to normal saline ] [ Designated as safety issue: No ]
  • Changes in visco-elasticity and lung function. [ Time Frame: after one month of two doses per day of N-acetylcysteine compared to normal saline. ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetylcysteine
Inhalation with N-Acetylcysteine
Drug: Acetylcysteine
Inhalation with N-Acetylcysteine
Placebo Comparator: normal saline
Inhalation with normal saline solution
Drug: normal saline
Inhalation with normal saline solution

  Eligibility

Ages Eligible for Study:   6 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996424

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
BVSM
Investigators
Principal Investigator: Sabine Van Daele, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Sabine Van Daele, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00996424     History of Changes
Other Study ID Numbers: 2009/464
Study First Received: October 15, 2009
Last Updated: August 12, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on September 15, 2014