This trial is active, not recruiting.

Condition non cystic fibrosis bronchiectasis
Treatment ciprofloxacin
Phase phase 3
Sponsor Aradigm Corporation
Collaborator Grifols Therapeutics Inc.
Start date April 2014
End date July 2016
Trial size 255 participants
Trial identifier NCT01515007, ARD-3150-1201


The DRCFI treatment will influence the time to first pulmonary exacerbation compared to placebo.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Dual Release Ciprofloxacin for Inhalation
once daily for 28 days on and 28 days off for six cycles
(Placebo Comparator)
Placebo Liposomes for Inhalation
once daily for 28 days on and 28 days off for six cycles

Primary Outcomes

Time to first exacerbation
time frame: One Year

Secondary Outcomes

Number of exacerbations
time frame: One Year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Verified bronchiectasis diagnosis - Pseudomonas aeruginosa lung infection Exclusion Criteria: - Cystic Fibrosis

Additional Information

Official title A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Time to First Pulmonary Exacerbation, Safety and Efficacy of ARD-3150 (Dual Release Ciprofloxacin for Inhalation-DRCFI) Compared With Placebo in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Aradigm Corporation.