Clinical trial NCT01515007: Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Cystic Fibrosis Bronchiectasis
Keywords: Bronchiectasis, non-CF, Ciprofloxacin, Liposome
Lead sponsor: Savara Inc.
Sponsor class: INDUSTRY
Collaborators: name: Grifols Therapeutics LLC
First posted: 2012-01-23
Enrollment: 278
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-3150-1201, 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.


Eligibility criteria: Inclusion Criteria:

* Verified bronchiectasis diagnosis
* Pseudomonas aeruginosa lung infection

Exclusion Criteria:

* Cystic Fibrosis

Primary outcomes:
measure: Time to first exacerbation
timeFrame: One Year
Secondary outcomes:
measure: Number of exacerbations
timeFrame: One Year
Other outcomes:
Locations:
city: Peoria
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Downey
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Poway
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Celebration
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Sebring
country: United States
state: Florida
city: Kailua
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Columbia
country: United States
state: Maryland
city: Royal Oak
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Lincoln
country: United States
state: Nebraska
city: Cedar Knolls
country: United States
state: New Jersey
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Huntersville
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Anderson
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Fort Worth
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Falls Church
country: United States
state: Virginia
city: Concord
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Cairns
country: Australia
state: Queensland
city: South Brisbane
country: Australia
state: Queensland
city: Daw Park
country: Australia
state: South Australia
city: Footscray
country: Australia
state: Victoria
city: Heidelberg
country: Australia
state: Victoria
city: Adelaide
country: Australia
city: Calgary
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Montreal
country: Canada
state: Quebec
city: Borstel
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Donaustaff
country: Germany
city: Freiburg
country: Germany
city: Hannover
country: Germany
city: Immenstadt im Allgau
country: Germany
city: Lubeck
country: Germany
city: Munich
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Miskolc
country: Hungary
city: Szombathely
country: Hungary
city: Dublin
country: Ireland
city: Galway
country: Ireland
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Kfar-Saba
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Pavia
country: Italy
state: PV
city: Acquaviva delle Fonti
country: Italy
city: Bologna
country: Italy
city: Ferrara
country: Italy
city: Firenze
country: Italy
city: Milano
country: Italy
city: Pisa
country: Italy
city: Busan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Cekule
country: Latvia
city: Daugavpils
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Bialystok
country: Poland
city: Chrzanow
country: Poland
city: Warsaw
country: Poland
city: Wroclaw
country: Poland
city: Bucuresti
country: Romania
city: Constanta
country: Romania
city: Timisoara
country: Romania
city: Durban
country: South Africa
state: KwaZulu-Natal
city: Pietermaritzburg
country: South Africa
state: KwaZulu-Natal
city: Amanzimtoti
country: South Africa
city: Cape Town
country: South Africa
city: Krugersdorp
country: South Africa
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Barcelona
country: Spain
city: Girona
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Kaohsiung
country: Taiwan
city: Taichung City
country: Taiwan
city: Taipei City
country: Taiwan
city: Glasgow
country: United Kingdom
state: Scotland
city: Birmingham
country: United Kingdom
state: West Midlands
city: Bradford
country: United Kingdom
city: Dundee
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Llandough
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle upon Tyne
country: United Kingdom
city: Nottinghamshire
country: United Kingdom
city: Stoke-on-Trent
country: United Kingdom
city: Tyne And Wear
country: United Kingdom
city: Wolverhampton
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.