Trial Condition(s):

Bronchiectasis

Ciprofloxacin Dry Powder for Inhalation (DPI) in non-cystic fibrosis bronchiectasis (non–CF BE) (RESPIRE 2)

Bayer Identifier:

15626

ClinicalTrials.gov Identifier:

NCT02106832

EudraCT Number:

2013-004659-19

Study Completed

Trial Purpose

The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

Inclusion Criteria
- Patients with a proven and documented diagnosis of non CF idiopathic or post infectious bronchiectasis
- Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks
Exclusion Criteria
- Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted
- Active allergic bronchopulmonary aspergillosis
- Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis
- Primary diagnosis of Chronic obstructive pulmonary disease (COPD)

Trial Summary

Enrollment Goal
521
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Hannover, Germany, 30173

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 10717

Status
Completed
 
Locations

Investigative Site

Greenville, United States, 29615

Status
Completed
 
Locations

Investigative Site

Peoria, United States, 85381

Status
Terminated
 
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Investigative Site

VELDHOVEN, Netherlands, 5500 MB

Status
Completed
 
Locations

Investigative Site

ALKMAAR, Netherlands, 1815 JD

Status
Completed
 
Locations

Investigative Site

ASSEN, Netherlands, 9403 RK

Status
Completed
 
Locations

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HELMOND, Netherlands, 5707 HA

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 135-720

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 136-705

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 120-752

Status
Completed
 
Locations

Investigative Site

Bucheon, South Korea, 420-717

Status
Completed
 
Locations

Investigative Site

Daejeon, South Korea, 301-723

Status
Completed
 
Locations

Investigative Site

Incheon Gwangyeogsi,, South Korea, 403-720

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 100-032

Status
Completed
 
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Investigative Site

Seoul, South Korea, 130-872

Status
Completed
 
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Investigative Site

Seoul, South Korea, 03080

Status
Completed
 
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Investigative Site

Vilnius, Lithuania, LT-08661

Status
Completed
 
Locations

Investigative Site

Klaipeda, Lithuania, LT-92288

Status
Completed
 
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Investigative Site

Moscow, Russia, 105229

Status
Completed
 
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Yaroslavl, Russia, 150003

Status
Completed
 
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St. Petersburg, Russia, 196084

Status
Completed
 
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Moscow, Russia, 127015

Status
Completed
 
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Nizhny Novgorod, Russia, 603035

Status
Terminated
 
Locations

Investigative Site

Moscow, Russia, 115682

Status
Completed
 
Locations

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St. Petersburg, Russia, 194356

Status
Completed
 
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Daegu, South Korea, 42415

Status
Completed
 
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Incheon, South Korea, 21565

Status
Completed
 
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San Diego, United States, 92120

Status
Completed
 
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Mineola, United States, 11501

Status
Terminated
 
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Kissimmee, United States, 34741

Status
Terminated
 
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KRAKOW, Poland, 31-455

Status
Completed
 
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Bielsko-Biala, Poland, 43-300

Status
Completed
 
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GRUDZIADZ, Poland, 86-300

Status
Terminated
 
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Investigative Site

MROZY, Poland, 05-320

Status
Completed
 
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Investigative Site

Ruse, Bulgaria, 7000

Status
Completed
 
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Investigative Site

Sofia, Bulgaria, 1606

Status
Completed
 
Locations

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Lovech, Bulgaria, 5500

Status
Completed
 
Locations

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Razgrad, Bulgaria, 7200

Status
Completed
 
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Kozloduy, Bulgaria, 3320

Status
Completed
 
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Porto Alegre, Brazil, 90035-074

Status
Completed
 
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Sao Paulo, Brazil, 05403-900

Status
Terminated
 
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Sao Paulo, Brazil, 01244-030

Status
Terminated
 
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Taipei, Taiwan, China, 10002

Status
Completed
 
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New Taipei City,, Taiwan, China, 23561

Status
Completed
 
Locations

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Chiayi, Taiwan, China, 613

Status
Terminated
 
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Moscow, Russia, 129090

Status
Completed
 
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GRONINGEN, Netherlands, 9728 NT

Status
Terminated
 
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Cape Town, South Africa, 7500

Status
Terminated
 
Locations

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Johannesburg, South Africa, 2092

Status
Terminated
 
Locations

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Cape Town, South Africa, 7764

Status
Completed
 
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Amanzimtoti, South Africa, 4127

Status
Completed
 
Locations

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Sofia, Bulgaria, 1000

Status
Terminated
 
Locations

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Sevlievo, Bulgaria, 5400

Status
Completed
 
Locations

Investigative Site

Sliven, Bulgaria, 8800

Status
Completed
 
Locations

Investigative Site

Graz, Austria, 8036

Status
Completed
 
Locations

Investigative Site

Belo Horizonte, Brazil, 30150-221

Status
Terminated
 
Locations

Investigative Site

Porto Alegre, Brazil, 90610-000

Status
Terminated
 
Locations

Investigative Site

São Paulo, Brazil, 04266-010

Status
Terminated
 
Locations

Investigative Site

Recife, Brazil, 50920640

Status
Terminated
 
Locations

Investigative Site

Porto Alegre, Brazil, 90880-480

Status
Completed
 
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Investigative Site

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Kowloon, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

New Territories, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Shatin, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 14059

Status
Completed
 
Locations

Investigative Site

Gelsenkirchen, Germany, 45879

Status
Completed
 
Locations

Investigative Site

Leipzig, Germany, 04357

Status
Completed
 
Locations

Investigative Site

Bad Berka, Germany, 99437

Status
Completed
 
Locations

Investigative Site

Long Beach, United States, 90813

Status
Completed
 
Locations

Investigative Site

Tampa, United States, 33613

Status
Terminated
 
Locations

Investigative Site

Decatur, United States, 30033

Status
Terminated
 
Locations

Investigative Site

Kaohsiung, Taiwan, China, 807

Status
Completed
 
Locations

Investigative Site

Taichung, Taiwan, China, 40447

Status
Completed
 
Locations

Investigative Site

Pendik, Turkey, 34890

Status
Terminated
 
Locations

Investigative Site

Maltepe, Turkey, 34844

Status
Completed
 
Locations

Investigative Site

Kampus, Turkey, 07058

Status
Completed
 
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Investigative Site

Ankara, Turkey, 061100

Status
Completed
 
Locations

Investigative Site

Sehitkamil, Turkey, 27310

Status
Completed
 
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Investigative Site

Balcali, Turkey, 01330

Status
Completed
 
Locations

Investigative Site

Rochester, United States, 55905

Status
Completed
 
Locations

Investigative Site

Sarasota, United States, 34239

Status
Completed
 
Locations

Investigative Site

Skokie, United States, 60076

Status
Completed
 
Locations

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Ufa, Russia, 450071

Status
Completed
 
Locations

Investigative Site

Voronezh, Russia, 394066

Status
Completed
 
Locations

Investigative Site

St. Petersburg, Russia, 194295

Status
Completed
 
Locations

Investigative Site

Edinburg, United States, 78539

Status
Terminated
 
Locations

Investigative Site

Brooklyn, United States, 11229

Status
Completed
 
Locations

Investigative Site

Asheville, United States, 28801

Status
Terminated
 
Locations

Investigative Site

Doylestown, United States, 18901

Status
Completed
 
Locations

Investigative Site

Gorzow Wielkopolski, Poland, 66-400

Status
Terminated
 
Locations

Investigative Site

Ostrowiec Swietokrzyski, Poland, 27-400

Status
Completed
 
Locations

Investigative Site

Samsun, Turkey, 55139

Status
Completed
 
Locations

Investigative Site

Praha 2, Czech Republic, 121 11

Status
Completed
 
Locations

Investigative Site

Prague 4, Czech Republic, 140 46

Status
Completed
 
Locations

Investigative Site

Praha 8, Czech Republic, 180 81

Status
Completed
 
Locations

Investigative Site

Brno, Czech Republic, 625 00

Status
Terminated
 
Locations

Investigative Site

Olathe, United States, 66061

Status
Completed
 
Locations

Investigative Site

Newport Beach, United States, 92663

Status
Completed
 
Locations

Investigative Site

La Jolla, United States, 92037

Status
Terminated
 
Locations

Investigative Site

Bangkok, Thailand, 10700

Status
Terminated
 
Locations

Investigative Site

Chiangmai, Thailand, 50200

Status
Terminated
 
Locations

Investigative Site

NakhonRatchasima, Thailand, 30000

Status
Completed
 
Locations

Investigative Site

Khon Kaen, Thailand, 40002

Status
Completed
 
Locations

Investigative Site

Bangkok, Thailand, 10400

Status
Completed
 
Locations

Investigative Site

Perth, Australia, 6009

Status
Completed
 
Locations

Investigative Site

New Lambton Heights, Australia, 2305

Status
Completed
 
Locations

Investigative Site

Adelaide, Australia, 5042

Status
Completed
 
Locations

Investigative Site

Godoy Cruz, Argentina, 5501

Status
Completed
 
Locations

Investigative Site

Vicente López, Argentina, 1638

Status
Completed
 
Locations

Investigative Site

Buenos Aires, Argentina, C1425DES

Status
Terminated
 
Locations

Investigative Site

Córdoba, Argentina, X5003DCE

Status
Completed
 
Locations

Investigative Site

Capital Federal, Argentina, 1425

Status
Terminated
 
Locations

Investigative Site

Bucharest, Romania, 011461

Status
Completed
 
Locations

Investigative Site

Iasi, Romania, 700141

Status
Completed
 
Locations

Investigative Site

Lisboa, Portugal, 1769-001

Status
Completed
 
Locations

Investigative Site

Angra do Heroísmo, Portugal, 9701-856

Status
Terminated
 
Locations

Investigative Site

Lisboa, Portugal, 1649-035

Status
Completed
 
Locations

Investigative Site

Faro, Portugal, 8000-386

Status
Terminated
 
Locations

Investigative Site

Vila Nova de Gaia, Portugal, 4434-502

Status
Completed
 
Locations

Investigative Site

Salzburg, Austria, 5020

Status
Terminated
 
Locations

Investigative Site

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

Investigative Site

Warszawa, Poland, 01-868

Status
Completed
 
Locations

Investigative Site

Udonthani, Thailand, 41000

Status
Terminated
 
Locations

Investigative Site

Suzhou, China, 215006

Status
Completed
 
Locations

Investigative Site

Shenyang, China, 110004

Status
Completed
 
Locations

Investigative Site

Wuxi, China, 214023

Status
Completed
 
Locations

Investigative Site

Fuzhou, China, 350025

Status
Terminated
 
Locations

Investigative Site

Shanghai, China, 200032

Status
Terminated
 
Locations

Investigative Site

Chongqing, China, 400042

Status
Completed
 
Locations

Investigative Site

Chengdu, China, 610041

Status
Completed
 
Locations

Investigative Site

Nanchang, China, 330006

Status
Completed
 
Locations

Investigative Site

Yinchuan, China, 750004

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510120

Status
Terminated
 
Locations

Investigative Site

Hohehot, China, 010050

Status
Completed
 
Locations

Investigative Site

shanghai, China, 200433

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100029

Status
Completed
 
Locations

Investigative Site

Shanghai, China, 200040

Status
Terminated
 
Locations

Investigative Site

Beijing, China, 100144

Status
Completed
 
Locations

Investigative Site

Novosibirsk, Russia, 630047

Status
Completed
 
Locations

Investigative Site

Novosibirsk, Russia, 630087

Status
Completed
 
Locations

Investigative Site

Miami, United States, 33126

Status
Completed
 
Locations

Investigative Site

Treuenbrietzen, Germany, 14929

Status
Terminated
 
Locations

Investigative Site

Rzeszow, Poland, 35-301

Status
Terminated
 
Locations

Investigative Site

Chelyabinsk, Russia, 454076

Status
Completed
 
Locations

Investigative Site

Talsi, Latvia, LV-3201

Status
Terminated
 
Locations

Investigative Site

Riga, Latvia, LV-1001

Status
Completed
 
Locations

Investigative Site

Riga, Latvia, LV-1002

Status
Completed
 
Locations

Investigative Site

Daugavpils, Latvia, LV-5410

Status
Completed
 
Locations

Investigative Site

Kraslava, Latvia, 5601

Status
Completed
 
Locations

Investigative Site

Jurmala, Latvia, LV-2010

Status
Completed
 
Locations

Investigative Site

Riga, Latvia, LV-1011

Status
Completed
 
Locations

Investigative Site

Riga, Latvia, LV-1038

Status
Completed
 
Locations

Investigative Site

Daugavpils, Latvia, LV-5403

Status
Completed
 
Locations

Investigative Site

Ploiesti, Romania, 100184

Status
Completed
 
Locations

Investigative Site

Bucharest, Romania, 030303

Status
Completed
 
Locations

Investigative Site

Bucharest, Romania, 050159

Status
Completed
 
Locations

Investigative Site

Brasov, Romania, 500086

Status
Completed
 
Locations

Investigative Site

Codlea, Romania, 505100

Status
Completed
 
Locations

Investigative Site

Constanta, Romania, 900002

Status
Completed
 
Locations

Investigative Site

Bucharest, Romania, 010457

Status
Terminated
 
Locations

Investigative Site

Timisoara, Romania, 300310

Status
Completed
 
Locations

Investigative Site

Bragadiru, Romania, 077025

Status
Completed
 
Locations

Investigative Site

Gabrovo, Bulgaria, 5300

Status
Completed
 
Locations

Investigative Site

Phitsanulok, Thailand, 65000

Status
Completed
 
Locations

Investigative Site

Ankara, Turkey, 06110

Status
Completed
 
Locations

Investigative Site

Konya, Turkey, 42080

Status
Completed
 
Locations

Investigative Site

Kielce, Poland, 25-751

Status
Completed
 
Locations

Investigative Site

Czestochowa, Poland, 42-200

Status
Completed
 
Locations

Investigative Site

Kielce, Poland, 25-734

Status
Terminated
 
Locations

Investigative Site

Katowice, Poland, 40-954

Status
Completed
 
Locations

Investigative Site

Mersin, Turkey, 33343

Status
Completed
 
Locations

Investigative Site

Izmir, Turkey, 35040

Status
Completed
 
Locations

Investigative Site

Cacak, Serbia, 32000

Status
Completed
 
Locations

Investigative Site

Valjevo, Serbia, 14000

Status
Completed
 
Locations

Investigative Site

Kragujevac, Serbia, 34000

Status
Completed
 
Locations

Investigative Site

Knez Selo, Serbia, 18204

Status
Completed
 
Locations

Investigative Site

Belgrade, Serbia, 11000

Status
Completed
 
Locations

Investigative Site

Belgrade, Serbia, 11080

Status
Terminated
 
Locations

Investigative Site

Sombor, Serbia, 25000

Status
Completed
 
Locations

Investigative Site

Arkhangelsk, Russia, 163001

Status
Completed
 
Locations

Investigative Site

Presov, Slovakia, 080 01

Status
Terminated
 
Locations

Investigative Site

Bratislava, Slovakia, 821 06

Status
Completed
 
Locations

Investigative Site

Novosibirsk, Russia, 630075

Status
Completed
 
Locations

Investigative Site

Tomsk, Russia, 634063

Status
Completed
 
Locations

Investigative Site

Kielce, Poland, 25-035

Status
Terminated
 
Locations

Investigative Site

Ksawerow, Poland, 95-054

Status
Completed
 
Locations

Investigative Site

Sittard-Geleen, Netherlands, 6162 BG

Status
Completed
 
Locations

Investigative Site

Maastricht, Netherlands, 6229 HX

Status
Terminated
 
Locations

Investigative Site

Manila, Philippines, 1000

Status
Completed
 
Locations

Investigative Site

Quezon City, Philippines, NCR 1100

Status
Completed
 
Locations

Investigative Site

City of San Fernando, Philippines, 2000

Status
Completed
 
Locations

Investigative Site

Quezon City, Philippines, NCR 1104

Status
Completed
 
Locations

Investigative Site

Manila, Philippines, 1012

Status
Completed
 
Locations

Investigative Site

Sremska Kamenica, Serbia, 21204

Status
Completed
 
Locations

Investigative Site

Jena, Germany, 07740

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 22767

Status
Terminated
 
Locations

Investigative Site

Neu-Isenburg, Germany, 63263

Status
Completed
 
Locations

Investigative Site

Frankfurt, Germany, 60389

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30625

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510120

Status
Completed
 
Locations

Investigative Site

Adelaide, Australia, 5041

Status
Completed
 
Locations

Investigative Site

Parkville, Australia, 3050

Status
Completed
 
Locations

Investigative Site

Kogarah, Australia, 2217

Status
Completed
 
Locations

Investigative Site

Murdoch, Australia, 6150

Status
Completed
 
Locations

Investigative Site

Tyler, United States, 75708-3154

Status
Terminated
 
Locations

Investigative Site

Portland, United States, 97239

Status
Terminated
 
Locations

Investigative Site

Fountain Valley, United States, 90708

Status
Terminated
 

Trial Design