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NCT02730793
Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease
Phase 2 trial testing Oral Aztreonam in Cystic Fibrosis in 5 participants. Terminated before completion.
19 September 2019
Quick facts
| Lead sponsor | Virginia Commonwealth University |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 1 January 2017 |
| Primary completion | 19 September 2019 |
| Estimated completion | 19 September 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Oral Aztreonam — full drug profile →
- Nasal Aztreonam — full drug profile →
- Nasal Placebo
Conditions studied
- Cystic Fibrosis — all drugs for Cystic Fibrosis →
Sponsor
Virginia Commonwealth University
Who can join
Adults 7 to 100, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Protocol-defined Pulmonary Exacerbations Treated With IV Anti-pseudomonal Antibiotics on Day 140
Time frame: 140 days
Protocol-Defined Pulmonary Exacerbation includes events that are characterized by change or worsening pulmonary symptoms (increased cough, increased sputum production and chest congestion, decreased appetite and exercise tolerance), loss of weight, and lung function decline that prompt initation of antibiotic therapy. Protocol-defined exacerbations in subjects that warrant treatment with IV antibi
Sponsor's own description
This study is designed as a masked, two center, randomized, placebo-controlled pilot study to evaluate the safety and efficacy of nasal and oral inhalation of 75 mg aztreonam in subjects with CF and lung infection due to PA. The study will involve two sites: Virginia Commonwealth University Medical Center (VCU) and Eastern Virginia Medical School (EVMS). Potential subjects will be identified in each site's CF clinic.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Inhaled anti-pseudomonal antibiotics for long-term therapy in cystic fibrosis.
Smith S, Rowbotham NJ. · · 2022 · cited 18× · PMID 36373968 · DOI 10.1002/14651858.cd001021.pub4
Verify or expand the search:
- PubMed search for NCT02730793
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cystic Fibrosis
Currently open trials in the same condition.
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- NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
- NCT06810167 — Assessing Tenapanor as a Treatment of CF-related Constipation. · Phase 3 · recruiting
- NCT06962852 — A Long-term Study to Monitor the Health Status of People With Cystic Fibrosis Who Took Part in a Previous Study With BI · Phase 1, PHASE2 · active not recruiting
Other Virginia Commonwealth University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02730793 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Virginia Commonwealth University
- Last refreshed: 11 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02730793.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing