Clinical trial NCT02104245: Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
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 Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Cystic Fibrosis Bronchiectasis
Keywords: Non Cystic Fibrosis Bronchiectasis, Pulmaquin, Ciprofloxacin, Pseudomonas aeruginosa
Lead sponsor: Savara Inc.
Sponsor class: INDUSTRY
Collaborators: name: Grifols Therapeutics LLC
First posted: 2014-04-04
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to first pulmonary exacerbation (from baseline)
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Danbury
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Duluth
country: United States
state: Georgia
city: Port Huron
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Lebanon
country: United States
state: New Hampshire
city: Summit
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Rock Hill
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Tyler
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Greenslopes
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Nedlands
country: Australia
state: Western Australia
city: Perth
country: Australia
state: Western Australia
city: Vancouver
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: St-Jerome
country: Canada
state: Quebec
city: Belgrade
country: Former Serbia and Montenegro
city: Knez Selo
country: Former Serbia and Montenegro
city: Kragujevac
country: Former Serbia and Montenegro
city: Sremska Kamenica
country: Former Serbia and Montenegro
city: Créteil Cedex 01
country: France
city: Grenoble cedex
country: France
city: Nice Cedex 1
country: France
city: Pessac Cedex
country: France
city: Rouen Cedex
country: France
city: Toulouse cedex 9
country: France
city: Kutaisi
country: Georgia
city: Tbilisi
country: Georgia
city: Budapest
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szekesfehervar
country: Hungary
city: Torokbalint
country: Hungary
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Tel-Aviv
country: Israel
city: Avellino
country: Italy
city: Napoli
country: Italy
city: Parma
country: Italy
city: Pisa
country: Italy
city: San Gerardo
country: Italy
city: Terni
country: Italy
city: Trieste
country: Italy
city: Suwon
country: Korea, Republic of
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Otahuhu
country: New Zealand
state: Auckland
city: Hamilton
country: New Zealand
state: Waikato
city: Tauranga
country: New Zealand
city: Jesus Maria
country: Peru
state: Lima
city: La Victoria
country: Peru
state: Lima
city: Pueblo Libre
country: Peru
state: Lima
city: San Juan de Miraflores
country: Peru
state: Lima
city: Bialystok
country: Poland
city: Krakow
country: Poland
city: Ruda Slaska
country: Poland
city: Warsaw
country: Poland
city: Arad
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Barcelona
country: Spain
city: La Coruna
country: Spain
city: Lleida
country: Spain
city: Valencia
country: Spain
city: Stockton-on-Trees
country: United Kingdom
state: Cleveland
city: Wigan
country: United Kingdom
state: Greater Manchester
city: Cambridge
country: United Kingdom
city: Colchester
country: United Kingdom
city: Cottingham
country: United Kingdom
city: Lancaster
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: North Sheilds
country: United Kingdom
city: Southampton
country: United Kingdom
city: Telford
country: United Kingdom
Study officials:
References:
citation: Chalmers JD, Cipolla D, Thompson B, Davis AM, O'Donnell A, Tino G, Gonda I, Haworth C, Froehlich J. Changes in respiratory symptoms during 48-week treatment with ARD-3150 (inhaled liposomal ciprofloxacin) in bronchiectasis: results from the ORBIT-3 and -4 studies. Eur Respir J. 2020 Oct 22;56(4):2000110. doi: 10.1183/13993003.00110-2020. Print 2020 Oct.
citation: Haworth CS, Bilton D, Chalmers JD, Davis AM, Froehlich J, Gonda I, Thompson B, Wanner A, O'Donnell AE. 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. Lancet Respir Med. 2019 Mar;7(3):213-226. doi: 10.1016/S2213-2600(18)30427-2. Epub 2019 Jan 15.