BronchiectasisNCT07293884
N- Acetylcysteine in Airway Clearance in Bronchiectasis
A study testing N Acetyle cysteine given by IV injection and Nebulized N Acetyle cysteine in people with Bronchiectasis, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- N Acetyle cysteine given by IV injection and Nebulized N Acetyle cysteine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2026to 23 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Clinical and high-resolution CT diagnosis of non-cystic fibrosis bronchiectasis.
- Hospital admission due to an acute exacerbation of bronchiectasis.
Who cannot join
- Cystic fibrosis.
- Traction bronchiectasis secondary to interstitial lung disease.
- Active pulmonary tuberculosis.
- Massive hemoptysis.
- Known hypersensitivity to N-acetylcysteine (NAC).
- Pregnancy or lactation.
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- Primary diagnosis of chronic obstructive pulmonary disease (COPD).
- Primary diagnosis of bronchial asthma.
- Immediate indication for invasive mechanical ventilation.
- Inability to provide informed consent or reliably complete symptom assessments.
- Absence of baseline expectoration difficulty (score 0 on the four-point scale).
- Transient bronchial dilatation secondary to acute consolidation or atelectasis.
- Uncertain diagnosis of permanent bronchiectasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Nebulized Versus Intravenous N- Acetylcysteine in Airway Clearance in Bronchiectasis
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
Read the detailed description
Background and Rationale
Bronchiectasis is a chronic respiratory condition characterized by impaired mucus clearance, persistent airway inflammation, and recurrent respiratory infections. During acute exacerbations, increased sputum viscosity and difficulty with expectoration may worsen respiratory symptoms and contribute to hospitalization.
N-acetylcysteine (NAC) is a mucolytic agent that reduces mucus viscosity by disrupting disulfide bonds within mucin glycoproteins. Although NAC can be administered through different routes, direct comparative evidence regarding nebulized and intravenous administration during acute exacerbations of non-cystic fibrosis bronchiectasis remains limited.
Study Design and Interventions
This prospective, single-center, two-arm, parallel-group randomized controlled trial was conducted at the Chest Department, Assiut University Hospitals, Egypt. A total of 100 hospitalized adults with acute exacerbations of non-cystic fibrosis bronchiectasis were randomly allocated in a 1:1 ratio to two treatment groups.
Participants in the nebulized NAC group received acetylcysteine 300 mg twice daily through a jet nebulizer. Participants in the intravenous NAC group received acetylcysteine 600 mg twice daily. Both groups received standard treatment, including appropriate antibiotics, individualized supportive care, and airway-clearance physiotherapy. Bronchodilators were administered according to clinical indications. The assigned NAC regimens were continued for up to seven days or until protocol-defined treatment cessation.
Because the routes of administration differed, participants and treating clinicians were not blinded. Outcome assessors were blinded to treatment allocation, and coded treatment-group labels were used during data analysis.
Primary Outcome
The primary endpoint was the change in expectoration-difficulty score from baseline to Day 3, approximately 72 hours after the first allocated NAC dose.
Expectoration difficulty was assessed using a four-point ordinal scale ranging from 0 (no difficulty) to 3 (marked difficulty). Improvement was calculated as the baseline score minus the Day-3 score, with positive values indicating improved expectoration. The primary efficacy comparison evaluated the difference in mean improvement between the two randomized treatment groups.
Secondary Outcomes
Secondary outcomes included improvement in expectoration difficulty at the final assessment, sputum viscosity and purulence, 24-hour sputum volume, cough severity, time to clinical stability, length of hospital stay, treatment escalation, treatment failure, treatment adherence, NAC-attributed adverse reactions, and 30-day bronchiectasis-related readmission.
Clinical and sputum assessments were conducted at baseline, on Day 3, and on Day 7 or earlier following clinical stabilization, using the same assessment schedule criteria in both treatment groups. Follow-up continued for up to 30 days to document subsequent clinical outcomes.
Study Objective
The study aimed to compare the efficacy and tolerability of two defined NAC treatment regimens administered as adjuncts to standard care during acute exacerbations of non-cystic fibrosis bronchiectasis. Because both the administered doses and routes differed, the comparison evaluated the studied regimens rather than independently isolating the effect of administration route.
- Conditions
- Bronchiectasis
- Being tested
- N Acetyle cysteine given by IV injection, Nebulized N Acetyle cysteine
- Keywords
- bronchiectasis, N-acetylcysteine
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N Acetyle cysteine given by IV injectionDrug
Also called Intravenous Acetylcysteine
Arm: IV N Acetyle cysteine
Nebulized N Acetyle cysteineDrug
Also called N-Acetylcysteine (Nebulized NAC)
Arm: Nebulized N Acetyle cysteine
| Study group | Role | What they receive |
|---|---|---|
| IV N Acetylcysteine | Active comparator | Participants received N-Acetylcysteine (NAC) 600 mg intravenously twice daily. Each dose was diluted with sterile 0.9% saline to a final volume of 10 mL and administered by slow intravenous infusion over at least 5 minutes. Treatment continued for up to 7 days or until protocol-defined treatment cessation. All participants also received standard treatment for acute bronchiectasis exacerbation, including antibiotics, supportive care, and airway-clearance physiotherapy. Receives: Drug: N Acetyle cysteine given by IV injection |
| Nebulized N Acetylcysteine | Experimental | Participants received N-Acetylcysteine (NAC) 300 mg by jet nebulization twice daily, using a 3-mL ampoule of 10% acetylcysteine solution per dose. Treatment continued for up to 7 days or until protocol-defined treatment cessation. Salbutamol 2.5 mg was administered by separate nebulization 10-15 minutes before NAC when clinically indicated. All participants also received standard treatment for acute bronchiectasis exacerbation, including antibiotics, supportive care, and airway-clearance physiotherapy. Receives: Drug: Nebulized N Acetyle cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Expectoration-Difficulty Score From Baseline to Day 3
Expectoration difficulty was assessed using a four-point ordinal scale (0-3 points): 0 = no difficulty, 1 = mild difficulty, 2 = moderate difficulty, and 3 = marked difficulty. The outcome was measured as the change in score (points), calculated as baseline minus Day-3 score. Positive change values indicate improvement in expectoration difficulty; zero indicates no change, and negative values indicate deterioration. A greater positive change indicates greater improvement.
Measured: Baseline to Day 3 (approximately 72 hours).
Secondary outcomes (4)
Sputum-Viscosity Score at Final Assessment
Sputum viscosity was assessed using a four-point ordinal scale (0-3 points): 0 = liquid (normal viscosity), 1 = fluid (mildly increased viscosity), 2 = viscous (moderately increased viscosity), and 3 = sticky (severely increased viscosity). The measurement unit was score points. Lower scores indicate lower sputum viscosity and a more favorable outcome; higher scores indicate greater viscosity.
Measured: Day 7 or earlier following clinical stabilization.
24-Hour Sputum Volume at Final Assessment
Spontaneously expectorated sputum was collected over a standardized 24-hour period using a graduated collection container. Sputum volume was measured in milliliters per 24 hours (mL/24 h). Higher values indicate greater sputum output, whereas lower values indicate less sputum output. The clinical interpretation depends on the assessment time and recovery phase; neither direction independently establishes clinical improvement.
Measured: Day 7 or earlier following clinical stabilization.
Expectoration-Difficulty Score at Final Assessment
Expectoration difficulty was assessed using a four-point ordinal scale (0-3 points): 0 = no difficulty, 1 = mild difficulty, 2 = moderate difficulty, and 3 = marked difficulty. The outcome was the expectoration-difficulty score recorded at the final assessment, expressed in score points. Lower scores indicate easier sputum expectoration and a more favorable clinical outcome; higher scores indicate greater expectoration difficulty.
Measured: Day 7 or earlier following clinical stabilization.
Time From Randomization to Initial Clinical Stability
Time in days from randomization to the first assessment at which predefined clinical stability criteria were simultaneously fulfilled and maintained for at least 24 consecutive hours. Criteria included stable vital signs, adequate oxygenation or return to baseline oxygen requirements, absence of acute ventilatory support, baseline mental status, and tolerance of oral intake and medications. Shorter times indicate earlier clinical stabilization.
Measured: From randomization to initial clinical stability during the index hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start17 Jan 2026
- Primary completion23 Jun 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Refaat Mahmoud, Assiut University
- Investigators
- Sahar R Mahmoud, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293884
- Sponsor's protocol ID
- NAcetylcysteine broncheictasis
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published trial results, including baseline characteristics, treatment allocation, efficacy outcomes, clinical outcomes, and safety data, will be available to qualified researchers upon reasonable request. A corresponding data dictionary will be provided. Data sharing will be subject to approval by the responsible institution, applicable ethical and confidentiality requirements, and a formal data-sharing agreement. No directly identifiable participant information will be released.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nebulized Versus Intravenous N- Acetylcysteine in Airway Clearance in Bronchiectasis
- ClinicalTrials.gov ID
- NCT07293884
- Acronym / sponsor ID
- NAcetylcysteine broncheictasis
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, N-acetylcysteine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Background and Rationale
Bronchiectasis is a chronic respiratory condition characterized by impaired mucus clearance, persistent airway inflammation, and recurrent respiratory infections. During acute exacerbations, increased sputum viscosity and difficulty with expectoration may worsen respiratory symptoms and contribute to hospitalization.
N-acetylcysteine (NAC) is a mucolytic agent that reduces mucus viscosity by disrupting disulfide bonds within mucin glycoproteins. Although NAC can be administered through different routes, direct comparative evidence regarding nebulized and intravenous administration during acute exacerbations of non-cystic fibrosis bronchiectasis remains limited.
Study Design and Interventions
This prospective, single-center, two-arm, parallel-group randomized controlled trial was conducted at the Chest Department, Assiut University Hospitals, Egypt. A total of 100 hospitalized adults with acute exacerbations of non-cystic fibrosis bronchiectasis were randomly allocated in a 1:1 ratio to two treatment groups.
Participants in the nebulized NAC group received acetylcysteine 300 mg twice daily through a jet nebulizer. Participants in the intravenous NAC group received acetylcysteine 600 mg twice daily. Both groups received standard treatment, including appropriate antibiotics, individualized supportive care, and airway-clearance physiotherapy. Bronchodilators were administered according to clinical indications. The assigned NAC regimens were continued for up to seven days or until protocol-defined treatment cessation.
Because the routes of administration differed, participants and treating clinicians were not blinded. Outcome assessors were blinded to treatment allocation, and coded treatment-group labels were used during data analysis.
Primary Outcome
The primary endpoint was the change in expectoration-difficulty score from baseline to Day 3, approximately 72 hours after the first allocated NAC dose.
Expectoration difficulty was assessed using a four-point ordinal scale ranging from 0 (no difficulty) to 3 (marked difficulty). Improvement was calculated as the baseline score minus the Day-3 score, with positive values indicating improved expectoration. The primary efficacy comparison evaluated the difference in mean improvement between the two randomized treatment groups.
Secondary Outcomes
Secondary outcomes included improvement in expectoration difficulty at the final assessment, sputum viscosity and purulence, 24-hour sputum volume, cough severity, time to clinical stability, length of hospital stay, treatment escalation, treatment failure, treatment adherence, NAC-attributed adverse reactions, and 30-day bronchiectasis-related readmission.
Clinical and sputum assessments were conducted at baseline, on Day 3, and on Day 7 or earlier following clinical stabilization, using the same assessment schedule criteria in both treatment groups. Follow-up continued for up to 30 days to document subsequent clinical outcomes.
Study Objective
The study aimed to compare the efficacy and tolerability of two defined NAC treatment regimens administered as adjuncts to standard care during acute exacerbations of non-cystic fibrosis bronchiectasis. Because both the administered doses and routes differed, the comparison evaluated the studied regimens rather than independently isolating the effect of administration route.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV N Acetylcysteine | Active comparator | Drug: N Acetyle cysteine given by IV injectionParticipants received N-Acetylcysteine (NAC) 600 mg intravenously twice daily. Each dose was diluted with sterile 0.9% saline to a final volume of 10 mL and administered by slow intravenous infusion over at least 5 minutes. Treatment continued for up to 7 days or until protocol-defined treatment cessation. All participants also received standard treatment for acute bronchiectasis exacerbation, including antibiotics, supportive care, and airway-clearance physiotherapy. |
| Nebulized N Acetylcysteine | Experimental | Drug: Nebulized N Acetyle cysteineParticipants received N-Acetylcysteine (NAC) 300 mg by jet nebulization twice daily, using a 3-mL ampoule of 10% acetylcysteine solution per dose. Treatment continued for up to 7 days or until protocol-defined treatment cessation. Salbutamol 2.5 mg was administered by separate nebulization 10-15 minutes before NAC when clinically indicated. All participants also received standard treatment for acute bronchiectasis exacerbation, including antibiotics, supportive care, and airway-clearance physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years or older.
- Clinical and high-resolution CT diagnosis of non-cystic fibrosis bronchiectasis.
- Hospital admission due to an acute exacerbation of bronchiectasis.
Key exclusion criteria (13 listed)
- Cystic fibrosis.
- Traction bronchiectasis secondary to interstitial lung disease.
- Active pulmonary tuberculosis.
- Massive hemoptysis.
- Known hypersensitivity to N-acetylcysteine (NAC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N Acetyle cysteine given by IV injectionAlso: Intravenous AcetylcysteineArm: IV N Acetyle cysteine | Drug | IV N Acetylcysteine |
| Nebulized N Acetyle cysteineAlso: N-Acetylcysteine (Nebulized NAC)Arm: Nebulized N Acetyle cysteine | Drug | Nebulized N Acetylcysteine |
Primary outcome
Change in Expectoration-Difficulty Score From Baseline to Day 3
Time frame: Baseline to Day 3 (approximately 72 hours).
Expectoration difficulty was assessed using a four-point ordinal scale (0-3 points): 0 = no difficulty, 1 = mild difficulty, 2 = moderate difficulty, and 3 = marked difficulty. The outcome was measured as the change in score (points), calculated as baseline minus Day-3 score. Positive change values indicate improvement in expectoration difficulty; zero indicates no change, and negative values indicate deterioration. A greater positive change indicates greater improvement.
4 secondary outcomes
Sputum-Viscosity Score at Final Assessment
Time frame: Day 7 or earlier following clinical stabilization.
24-Hour Sputum Volume at Final Assessment
Time frame: Day 7 or earlier following clinical stabilization.
Expectoration-Difficulty Score at Final Assessment
Time frame: Day 7 or earlier following clinical stabilization.
Time From Randomization to Initial Clinical Stability
Time frame: From randomization to initial clinical stability during the index hospitalization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published trial results, including baseline characteristics, treatment allocation, efficacy outcomes, clinical outcomes, and safety data, will be available to qualified researchers upon reasonable request. A corresponding data dictionary will be provided. Data sharing will be subject to approval by the responsible institution, applicable ethical and confidentiality requirements, and a formal data-sharing agreement. No directly identifiable participant information will be released.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahar R Mahmoud, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N Acetyle cysteine given by IV injection and Nebulized N Acetyle cysteine in people with Bronchiectasis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Expectoration-Difficulty Score From Baseline to Day 3 (time frame: Baseline to Day 3 (approximately 72 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.