NCT02104245

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension

Completed Phase 3 Last updated 23 March 2021

What this trial tests

Phase 3 trial testing Ciprofloxacin dispersion for inhalation in Non Cystic Fibrosis Bronchiectasis in 304 participants. Completed in 1 October 2016.

Timeline

28 May 2014

Primary endpoint
11 August 2016

1 October 2016

Quick facts

Lead sponsor	Aradigm Corporation
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	304
Start date	28 May 2014
Primary completion	11 August 2016
Estimated completion	1 October 2016
Sites	95 locations across United States, Australia, Canada, France, Georgia, Hungary, Israel, Italy

Drugs / interventions tested

• Ciprofloxacin dispersion for inhalation — full drug profile →
• Placebo

Conditions studied

• Non Cystic Fibrosis Bronchiectasis — all drugs for Non Cystic Fibrosis Bronchiectasis →

Sponsor

Aradigm Corporation — full company profile →

Who can join

18 and older, any sex, with Non Cystic Fibrosis Bronchiectasis. 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.

• Time to first pulmonary exacerbation (from baseline)
  Time frame: 48 weeks

Sponsor's own description

This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanomaterial-based therapeutics for antibiotic-resistant bacterial infections.
   Makabenta JMV, Nabawy A, Li CH, Schmidt-Malan S, et al · · 2021 · cited 751× · PMID 32814862 · DOI 10.1038/s41579-020-0420-1
2. Nano-Strategies to Fight Multidrug Resistant Bacteria-"A Battle of the Titans".
   Baptista PV, McCusker MP, Carvalho A, Ferreira DA, et al · · 2018 · cited 389× · PMID 30013539 · DOI 10.3389/fmicb.2018.01441
3. 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 trials.
   Haworth CS, Bilton D, Chalmers JD, Davis AM, et al · · 2019 · cited 155× · PMID 30658914 · DOI 10.1016/s2213-2600(18)30427-2
4. Therapeutic Strategies against Biofilm Infections.
   Mishra S, Gupta A, Upadhye V, Singh SC, et al · · 2023 · cited 67× · PMID 36676121 · DOI 10.3390/life13010172
5. Lipid Nanoparticles as Delivery Vehicles for Inhaled Therapeutics.
   Leong EWX, Ge R. · · 2022 · cited 64× · PMID 36140280 · DOI 10.3390/biomedicines10092179
6. Recent applications and strategies in nanotechnology for lung diseases.
   Zhong W, Zhang X, Zeng Y, Lin D, et al · · 2021 · cited 51× · PMID 33456721 · DOI 10.1007/s12274-020-3180-3
7. Interventions for bronchiectasis: an overview of Cochrane systematic reviews.
   Welsh EJ, Evans DJ, Fowler SJ, Spencer S. · · 2015 · cited 50× · PMID 26171905 · DOI 10.1002/14651858.cd010337.pub2
8. Nanoapproaches to Modifying Epigenetics of Epithelial Mesenchymal Transition for Treatment of Pulmonary Fibrosis.
   Skibba M, Drelich A, Poellmann M, Hong S, et al · · 2020 · cited 35× · PMID 33384604 · DOI 10.3389/fphar.2020.607689