- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07293884
N- Acetylcysteine in Airway Clearance in Broncheictasis
Efficacy of Nebulized Versus Intravenous N- Acetylcysteine in Airway Clearance in Broncheictasis
It has been deduced that reducing the production of mucus or improving the clearance of sputum in the airway is the key to enhance the therapeutic efficacy for bronchiectasis . Mucoactive drugs are commonly used to clear the airway in mucus hypersecretion diseases. Currently, investigators have found that N-acetylcysteine (NAC), an effective mucolytic agent, not only reduces the viscosity and elasticity of sputum, but it also has anti-inflammatory and antioxidant activity.
Additionally, the Spanish guidelines on the treatment of bronchiectasis indicate that the use of N-acetylcysteine should be considered for patients with bronchiectasis and COPD. Therefore, as a classic mucolytic agent with antioxidant and anti-inflammatory properties, N-acetylcysteine can be effective in the treatment of bronchiectasis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects aged above 18 years old; with a diagnosis of bronchiectasis who are admitted to chest department due to acute exacerbation
Exclusion Criteria:
- current smokers, a known allergy to N-acetylcysteine; pregnancy or lactation (for women); primary diagnosis of COPD or asthma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: IV N Acetyle cysteine
Intervention: N Acetyle cysteine given by IV injection
|
Arm: IV N Acetyle cysteine
|
|
Active Comparator: Nebulized N Acetyle cysteine
Intervention: Nebulized N Acetyle cysteine
|
Arm: Nebulized N Acetyle cysteine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sputum viscosity score
Time Frame: At the end of 1 week of treatment
|
Sputum viscosity score \(0\): Normal (liquid)\(1\): Mildly increased viscosity (fluid)\(2\): Moderately increased viscosity (viscous)\(3\): Severely increased viscosity (sticky)
|
At the end of 1 week of treatment
|
|
Amount of sputum
Time Frame: At the end of 1 week treatment
|
At the end of 1 week treatment
|
|
|
Expectoration difficulty score
Time Frame: At the end of 1 week of treatment
|
Expectoration difficulty score \(0\): No difficulty\(1\): Mild difficulty\(2\): Moderate difficulty\(3\): Marked difficulty
|
At the end of 1 week of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Need for mechanical ventilation
Time Frame: At the end of 1 week of treatment
|
At the end of 1 week of treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NAcetylcysteine broncheictasis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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