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

Non Cystic Fibrosis Bronchiectasis Clinical Trial

Official title:

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 Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515007
• Other study ID #: ARD-3150-1201
• Status: Completed
• Phase: Phase 3
• Start date: March 31, 2014
• Est. completion date: October 2016

Study information

• Verified date: March 2021
• Source: Savara Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study (ARD-3150-1201, ORBIT-3) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: October 2016
• Est. primary completion date: August 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Verified bronchiectasis diagnosis

• Pseudomonas aeruginosa lung infection

Exclusion Criteria:

• Cystic Fibrosis

Related Conditions & MeSH terms

• Bronchiectasis
• Fibrosis
• Non Cystic Fibrosis Bronchiectasis

Intervention

Drug:
• Ciprofloxacin dispersion for inhalation

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aradigm Corporation	Grifols Therapeutics LLC

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Korea, Republic of,  Latvia,  Poland,  Romania,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first exacerbation		One Year
Secondary	Number of exacerbations		One Year