Bronchiectasis, Non-Cystic FibrosisPhase 3NCT07274020
Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients
A Phase 3 study of Bronchiectasis, Non-Cystic Fibrosis, run by Assiut University at 1 site in Egypt.
Trial summary
Bronchiectasis is a chronic respiratory disease characterized by recurrent infections, inflammation, and progressive lung damage. Frequent exacerbations are associated with increased morbidity, accelerated lung function decline, and reduced quality of life. Preventing exacerbations is a key therapeutic goal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis, Non-Cystic Fibrosis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 ≥18 years of age.
- Confirmed diagnosis of non-cystic fibrosis bronchiectasis by high-resolution CT (HRCT).
- History of ≥2 bronchiectasis exacerbations in the previous 12 months.
Who cannot join
- Diagnosis of cystic fibrosis-related bronchiectasis.
- Known hypersensitivity or contraindication to fluoroquinolones (including moxifloxacin).
- Severe hepatic impairment or severe renal impairment (eGFR <30 mL/min/1.73 m²).
- Pregnancy or breastfeeding.
- History of significant QT prolongation, arrhythmia, or concurrent use of QT-prolonging drugs.
- Use of long-term suppressive antibiotics for bronchiectasis in the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University hospital
Asyut, Asyut Governorate, 71515
Montaser Gamal Elddin, Lecturer, +21008951058, Montaser_zahran@yahoo.com
About this study
Official title: Effectiveness and Safety of Long-Term Intermittent Moxifloxacin Eradication Therapy in Non-Cystic Fibrosis Bronchiectasis: A 12-Month Randomized Controlled Trial
Bronchiectasis is a chronic respiratory disease characterized by recurrent infections, inflammation, and progressive lung damage. Frequent exacerbations are associated with increased morbidity, accelerated lung function decline, and reduced quality of life. Preventing exacerbations is a key therapeutic goal. Moxifloxacin, a fluoroquinolone antibiotic with broad-spectrum activity, may play a role in intermittent eradication therapy to reduce bacterial load, achieve microbiological clearance, and minimize exacerbation frequency.
This randomized controlled trial will evaluate the effectiveness and safety of long-term intermittent moxifloxacin therapy compared with standard care in patients with non-cystic fibrosis bronchiectasis.
- Conditions
- Bronchiectasis, Non-Cystic Fibrosis
- Being tested
- Intermittent Moxifloxacin + Standard Care, Standard Care (in control arm)
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Moxifloxacin + Standard CareDrug
Moxifloxacin 400 mg orally once daily for 7 days every 8 weeks (total 6 cycles over 12 months), in addition to guideline-based standard care
Standard Care (in control arm)Other
Participants will receive guideline-based management of bronchiectasis without long-term suppressive antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Moxifloxacin + Standard Care | Experimental | Participants will receive moxifloxacin 400 mg orally once daily for 7 days every 8 weeks (total 6 cycles over 12 months) in addition to guideline-based standard care Receives: Drug: Intermittent Moxifloxacin + Standard Care |
| Standard Care (Control) | Active comparator | Participants will receive guideline-based standard care without long-term suppressive antibiotics. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation frequency
Number of acute bronchiectasis exacerbations per patient during follow-up
Measured: 12 months
Secondary outcomes (2)
Microbiological clearance
Rate of clearance of Pseudomonas aeruginosa and other pathogens from sputum cultures
Measured: 12 months
Change in FVC
Change in Forced vital capacity
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis, Non-Cystic FibrosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montaser Gamal Ahmed, Assiut University
- Investigators
- montaser gamal ahmed, gamal ahmed, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274020
- Sponsor's protocol ID
- ASSIUT-CH-MOXI-BE-25
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Long-Term Intermittent Moxifloxacin Eradication Therapy in Non-Cystic Fibrosis Bronchiectasis: A 12-Month Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07274020
- Acronym / sponsor ID
- ASSIUT-CH-MOXI-BE-25
- Conditions
- Bronchiectasis, Non-Cystic Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 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.
Bronchiectasis is a chronic respiratory disease characterized by recurrent infections, inflammation, and progressive lung damage. Frequent exacerbations are associated with increased morbidity, accelerated lung function decline, and reduced quality of life. Preventing exacerbations is a key therapeutic goal. Moxifloxacin, a fluoroquinolone antibiotic with broad-spectrum activity, may play a role in intermittent eradication therapy to reduce bacterial load, achieve microbiological clearance, and minimize exacerbation frequency.
This randomized controlled trial will evaluate the effectiveness and safety of long-term intermittent moxifloxacin therapy compared with standard care in patients with non-cystic fibrosis bronchiectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Moxifloxacin + Standard Care | Experimental | Drug: Intermittent Moxifloxacin + Standard CareParticipants will receive moxifloxacin 400 mg orally once daily for 7 days every 8 weeks (total 6 cycles over 12 months) in addition to guideline-based standard care |
| Standard Care (Control) | Active comparator | Other: Standard Care (in control arm)Participants will receive guideline-based standard care without long-term suppressive antibiotics. |
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 ≥18 years of age.
- Confirmed diagnosis of non-cystic fibrosis bronchiectasis by high-resolution CT (HRCT).
- History of ≥2 bronchiectasis exacerbations in the previous 12 months.
Key exclusion criteria (6 listed)
- Diagnosis of cystic fibrosis-related bronchiectasis.
- Known hypersensitivity or contraindication to fluoroquinolones (including moxifloxacin).
- Severe hepatic impairment or severe renal impairment (eGFR <30 mL/min/1.73 m²).
- Pregnancy or breastfeeding.
- History of significant QT prolongation, arrhythmia, or concurrent use of QT-prolonging drugs.
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 |
|---|---|---|
| Intermittent Moxifloxacin + Standard CareMoxifloxacin 400 mg orally once daily for 7 days every 8 weeks (total 6 cycles over 12 months), in addition to guideline-based standard care | Drug | Intermittent Moxifloxacin + Standard Care |
| Standard Care (in control arm)Participants will receive guideline-based management of bronchiectasis without long-term suppressive antibiotics. | Other | Standard Care (Control) |
Primary outcome
Exacerbation frequency
Time frame: 12 months
Number of acute bronchiectasis exacerbations per patient during follow-up
2 secondary outcomes
Microbiological clearance
Time frame: 12 months
Change in FVC
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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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.
montaser gamal ahmed, gamal ahmed 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 Phase 3 study of Bronchiectasis, Non-Cystic Fibrosis, 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 6 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: opening soon, as of the sponsor's last update on 10 Dec 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact montaser gamal ahmed, lecturer (+201008951058, montaser_zahran@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbation frequency (time frame: 12 months). 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 10 Dec 2025.