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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00996424
Recruitment Status : Terminated (Insufficient recruitment.)
First Posted : October 16, 2009
Last Update Posted : August 15, 2011
Information provided by:
University Hospital, Ghent

Brief Summary:

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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Acetylcysteine Drug: normal saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function.
Study Start Date : January 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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Ages Eligible for Study:   6 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00996424

University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Sabine Van Daele, MD, PhD University Hospital, Ghent

Additional Information:
Responsible Party: Sabine Van Daele, MD, PhD, University Hospital Ghent Identifier: NCT00996424     History of Changes
Other Study ID Numbers: 2009/464
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs