Summary
Ciprofloxacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cystic Fibrosis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cystic Fibrosis. ClinicalTrials.gov lists 8 registered trials linking Ciprofloxacin to Cystic Fibrosis: 1 is currently recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01400750). The largest enrolment is 304 participants (NCT00097773). Registration activity spans 2001 to 2024. The literature layer holds 11 publications for this pair: 5 Cochrane reviews, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2019 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Cystic Fibrosis ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Progressive lung function decline; no spontaneous remission; historically median survival 30 years; now >50 years with CFTR modulators for eligible genotypes.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 75.0 (trials 25.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 5 completed, 2 other |
| Linked publications | 11 (5 Cochrane reviews, 5 clinical trial publications, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | CFTR |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01400750 | Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis 2001 | completed | Phase 4 | 61 |
| NCT03262142 | Targeted AntiBiotics for Chronic Pulmonary Diseases 2018 | terminated | Phase 4 | 51 |
| NCT00889967 | Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1" 2010 | completed | Phase 2 | 95 |
| NCT00645788 | Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis 2008 | completed | Phase 2 | 288 |
| NCT00097773 | Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis 2004 | completed | Phase 2 | 304 |
| NCT06368804 | Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis 2024 | recruiting | Phase 2 | 196 |
| NCT00910351 | Cipro Inhaler for Cystic Fibrosis Children Ages 6-12 2009 | completed | Phase 1 | 19 |
| NCT01090908 | Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa 2010 | withdrawn | Not applicable | — |
Published literature
- Cochrane review Comparative efficacy and safety of inhaled antibiotics in managing chronic Pseudomonas aeruginosa infection in patients with cystic fibrosis and bronchiectasis: a systematic review and network meta-analysisChen Y, Meng X, Zhu J et al. · Journal of thoracic disease · 2025 · PMID 40223951
- Cochrane review Antibiotic treatment for non-tuberculous mycobacteria lung infection in people with cystic fibrosisJahnke N, Waters V, Ratjen F et al. · The Cochrane database of systematic reviews · 2025 · PMID 40145528
- Cochrane review Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosisLangton Hewer SC, Smith S, Rowbotham NJ et al. · The Cochrane database of systematic reviews · 2023 · PMID 37268599
- Clinical trial publication Targeted AntiBiotics for Chronic pulmonary diseases (TARGET ABC): can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa-infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis, and asthma? A multicenter, randomized, controlled, open-label trialEklöf J, Alispahic IA, Sivapalan P et al. · Trials · 2022 · PMID 36167555
- Cochrane review Safety and Efficacy of Devices Delivering Inhaled Antibiotics among Adults with Non-Cystic Fibrosis Bronchiectasis: A Systematic Review and a Network Meta-AnalysisTejada S, Ramírez-Estrada S, Forero CG et al. · Antibiotics (Basel, Switzerland) · 2022 · PMID 35203878
- Cochrane review Intermittent prophylactic antibiotics for bronchiectasisSpencer S, Donovan T, Chalmers JD et al. · The Cochrane database of systematic reviews · 2022 · PMID 34985761
- Clinical trial publication Intravenous or oral antibiotic treatment in adults and children with cystic fibrosis and Pseudomonas aeruginosa infection: the TORPEDO-CF RCTLangton Hewer SC, Smyth AR, Brown M et al. · Health technology assessment (Winchester, England) · 2021 · PMID 34806975
- Clinical trial publication Intravenous versus oral antibiotics for eradication of Pseudomonas aeruginosa in cystic fibrosis (TORPEDO-CF): a randomised controlled trialHewer SCL, Smyth AR, Brown M et al. · The Lancet. Respiratory medicine · 2020 · PMID 33007285
- Clinical trial publication Microbiological changes observed over 48 weeks of treatment with inhaled liposomal ciprofloxacin in individuals with non-cystic fibrosis bronchiectasis and chronic Pseudomonas aeruginosa lung infectionVanDevanter DR, Gonda I, Dahms J et al. · Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2019 · PMID 31035017
- Clinical trial publication Ciprofloxacin Dry Powder for Inhalation: Inspiratory Flow in Patients with Non-cystic Fibrosis BronchiectasisStass H, Nagelschmitz J, Kappeler D et al. · Journal of aerosol medicine and pulmonary drug delivery · 2019 · PMID 30848695
- Randomized controlled trial Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trialsHaworth CS, Bilton D, Chalmers JD et al. · The Lancet. Respiratory medicine · 2019 · PMID 30658914
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target CFTR. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Ciprofloxacin approved for Cystic Fibrosis?
Ciprofloxacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Cystic Fibrosis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Cystic Fibrosis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Ciprofloxacin in clinical trials for Cystic Fibrosis?
ClinicalTrials.gov lists 8 registered trials linking Ciprofloxacin to Cystic Fibrosis: 1 is currently recruiting; 5 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01400750). The largest enrolment is 304 participants (NCT00097773). Registration activity spans 2001 to 2024.
What does the evidence show for Ciprofloxacin in Cystic Fibrosis?
Ciprofloxacin has both completed registered trials and synthesis-level publications linked to Cystic Fibrosis. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target CFTR. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.