Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)

Aradigm

Status and phase: Completed; Phase 3

Conditions: Non Cystic Fibrosis Bronchiectasis

Treatments: Drug: Placebo; Drug: Ciprofloxacin dispersion for inhalation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02104245

ARD-3150-1202

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of non-CF bronchiectasis
• History of P. aeruginosa respiratory infections
• At least two pulmonary exacerbations treated with antibiotics in the previous year

Exclusion criteria

• Have a clinical diagnosis of CF
• Are pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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304 participants in 2 patient groups, including a placebo group

Ciprofloxacin dispersion for inhalation

Experimental group

Description:

Liquid mixture of liposomally encapsulated and unencapsulated ciprofloxacin

Treatment:

Drug: Ciprofloxacin dispersion for inhalation

Placebo

Placebo Comparator group

Description:

Liquid formulation of empty liposomes

Treatment:

Drug: Placebo