BronchiectasisPhase 3RESPIRE 2NCT02106832
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
A Phase 3 study testing Ciprofloxacin (BAYQ3939) dry powder for inhalation in people with Bronchiectasis, run by Bayer at 207 sites in 25 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Ciprofloxacin (BAYQ3939) dry powder for inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 521 participants
- Where
- 207 sitesin 25 countries
- Study dates
- 30 Apr 2014to 19 Oct 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
207 sites in 25 countries.
207 sites in 25 countries
United States22 sites
Study site
Asheville, North Carolina, 28801
Study site
Brooklyn, New York, 11229
Study site
Decatur, Georgia, 30033
Study site
Doylestown, Pennsylvania, 18901
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Edinburg, Texas, 78539
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Fountain Valley, California, 90708
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Greenville, South Carolina, 29615
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Kissimmee, Florida, 34741
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La Jolla, California, 92037
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Long Beach, California, 90813
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Miami, Florida, 33126
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Mineola, New York, 11501
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Newport Beach, California, 92663
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Olathe, Kansas, 66061
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Peoria, Arizona, 85381
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Portland, Oregon, 97239
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Rochester, Minnesota, 55905
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San Diego, California, 92120
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Sarasota, Florida, 34239
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Skokie, Illinois, 60076
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Tampa, Florida, 33613
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Tyler, Texas, 75708-3154
Russia17 sites
Study site
Arkhangelsk, 163001
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Chelyabinsk, 454076
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Moscow, 105229
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Moscow, 115682
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Moscow, 127015
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Moscow, 129090
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Nizhny Novgorod, 603035
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Novosibirsk, 630047
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Novosibirsk, 630075
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Novosibirsk, 630087
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Saint Petersburg, 194295
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Saint Petersburg, 194356
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Saint Petersburg, 196084
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Tomsk, 634063
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Ufa, 450071
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Voronezh, 394066
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Yaroslavl, 150003
China15 sites
Study site
Beijing, 100029
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Beijing, 100144
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Chengdu, Sichuan, 610041
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Chongqing, 400042
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Fuzhou, Fujian, 350025
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Guangzhou, Guangdong, 510120
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Hohehot, Inner Mongolia, 010050
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Nanchang, Jiangxi, 330006
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Shanghai, 200032
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Shanghai, 200040
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Shanghai, 200433
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Shenyang, Liaoning, 110004
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Suzhou, Jiangsu, 215006
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Wuxi, Jiangsu, 214023
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Yinchuan, Ningxia, 750004
Poland14 sites
Study site
Bielsko-Biala, 43-300
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Częstochowa, 42-200
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Gorzów Wielkopolski, 66-400
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Grudziądz, 86-300
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Katowice, 40-954
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Kielce, 25-035
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Kielce, 25-734
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Kielce, 25-751
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Krakow, 31-455
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Ksawerów, 95-054
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Mrozy, 05-320
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Ostrowiec Świętokrzyski, 27-400
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Rzeszów, 35-301
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Warsaw, 01-868
Germany12 sites
Study site
Bad Berka, Thuringia, 99437
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Berlin, 10717
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Berlin, 14059
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Frankfurt am Main, Hesse, 60389
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Gelsenkirchen, North Rhine-Westphalia, 45879
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Hamburg, 22767
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Hanover, Lower Saxony, 30173
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Hanover, Lower Saxony, 30625
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Jena, Thuringia, 07740
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Leipzig, Saxony, 04357
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Neu-Isenburg, Hesse, 63263
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Treuenbrietzen, Brandenburg, 14929
Romania11 sites
Study site
Bragadiru, 077025
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Brasov, 500086
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Bucharest, 010457
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Bucharest, 011461
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Bucharest, 030303
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Bucharest, 050159
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Codlea, 505100
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Constanța, 900002
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Iași, 700141
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Ploieşti, 100184
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Timișoara, 300310
South Korea11 sites
Study site
Bucheon-si, Gyeonggido, 420-717
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Daegu, 42415
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Daejeon, Daejeon Gwang''yeogsi, 301-723
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Incheon, 21565
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Incheon Gwangyeogsi,, Incheon Gwang''yeogsi, 403-720
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Seoul, Seoul Teugbyeolsi, 135-720
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Seoul, 03080
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Seoul, 100-032
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Seoul, 120-752
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Seoul, 130-872
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Seoul, 136-705
Turkey (Türkiye)11 sites
Study site
Ankara, 061100
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Ankara, 06110
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Balcalı, 01330
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Izmir, 35040
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Kampus, 07058
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Konya, 42080
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Maltepe, 34844
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Mersin, 33343
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Pendik, 34890
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Samsun, 55139
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Şehitkamil, 27310
Bulgaria10 sites
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Gabrovo, 5300
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Kozloduy, 3320
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Lovech, 5500
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Razgrad, 7200
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Rousse, 7000
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Sevlievo, 5400
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Sliven, 8800
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Sofia, 1000
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Sofia, 1606
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Stara Zagora, 6000
Latvia9 sites
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Daugavpils, LV-5403
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Daugavpils, LV-5410
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Jūrmala, LV-2010
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Krāslava, 5601
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Riga, LV-1001
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Riga, LV-1002
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Riga, LV-1011
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Riga, LV-1038
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Talsi, LV-3201
Brazil8 sites
Study site
Belo Horizonte, Minas Gerais, 30150-221
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Porto Alegre, Rio Grande do Sul, 90610-000
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Porto Alegre, Rio Grande do Sul, 90880-480
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Porto Alegre, 90035-074
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Recife, Pernambuco, 50920640
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São Paulo, São Paulo, 04266-010
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São Paulo, 01244-030
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São Paulo, 05403-900
Serbia8 sites
Study site
Belgrade, 11000
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Belgrade, 11080
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Čačak, 32000
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Kamenitz, 21204
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Knez-Selo, 18204
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Kragujevac, 34000
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Sombor, 25000
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Valjevo, 14000
Australia7 sites
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Adelaide, South Australia, 5041
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Adelaide, South Australia, 5042
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Kogarah, New South Wales, 2217
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Murdoch, Western Australia, 6150
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New Lambton Heights, New South Wales, 2305
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Parkville, Victoria, 3050
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Perth, Western Australia, 6009
Netherlands7 sites
Study site
Alkmaar, 1815 JD
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Assen, 9403 RK
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Groningen, 9728 NT
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Helmond, 5707 HA
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Maastricht, 6229 HX
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Sittard-Geleen, 6162 BG
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Veldhoven, 5500 MB
Thailand7 sites
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Bangkok, 10400
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Bangkok, 10700
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Chiang Mai, 50200
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Khon Kaen, 40002
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NakhonRatchasima, 30000
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Phitsanulok, 65000
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Udon Thani, 41000
Argentina5 sites
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1425DES
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Capital Federal, Ciudad Auton. de Buenos Aires, 1425
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Córdoba, X5003DCE
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Godoy Cruz, Mendoza Province, 5501
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Vicente López, 1638
Philippines5 sites
Study site
City of San Fernando, 2000
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Manila, 1000
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Manila, 1012
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Quezon City, NCR 1100
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Quezon City, NCR 1104
Portugal5 sites
Study site
Angra do Heroísmo, Azores, 9701-856
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Faro, 8000-386
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Lisbon, 1649-035
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Lisbon, 1769-001
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Vila Nova de Gaia, Porto District, 4434-502
Taiwan5 sites
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Chiayi City, 613
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Kaohsiung City, 807
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New Taipei City, 23561
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Taichung, 40447
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Taipei, 10002
Czechia4 sites
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Brno, 625 00
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Prague, 121 11
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Prague, 140 46
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Prague, 180 81
Hong Kong4 sites
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Hong Kong
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Kowloon
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New Territories
Study site
Shatin
South Africa4 sites
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Cape Town, Western Cape, 7500
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Cape Town, Western Cape, 7764
Study site
eManzimtoti, KwaZulu-Natal, 4127
Study site
Johannesburg, Gauteng, 2092
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.
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.
Read the detailed description
Number of participants with Adverse events will be covered in Adverse Events section.
- Conditions
- Bronchiectasis
- Being tested
- Ciprofloxacin (BAYQ3939) dry powder for inhalation, Placebo
- Keywords
- Ciprofloxacin, Dry Powder for Inhalation, Exacerbation, Bronchiectasis
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin (BAYQ3939) dry powder for inhalationDrug
Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.
Ciprofloxacin (BAYQ3939) dry powder for inhalationDrug
Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.
PlaceboDrug
Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off
PlaceboDrug
Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin DPI 28 Days on/off (Cipro 28) | Experimental | Subjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles). Receives: Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation |
| Ciprofloxacin DPI 14 Days on/off (Cipro 14) | Experimental | Subjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles). Receives: Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation |
| Placebo 28 Days on/off (Placebo 28) | Placebo comparator | Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles). Receives: Drug: Placebo |
| Placebo 14 Days on/off (Placebo 14) | Placebo comparator | Subjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo
Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
Measured: Up to Week 48
Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo
Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
Measured: Up to Week 48
Secondary outcomes (7)
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.
Measured: Up to Week 48
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.
Measured: Up to Week 48
Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.
Measured: End of treatment (Week 44/46)
Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)
The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.
Measured: Baseline and end of treatment (Week 44/46)
Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.
Measured: End of treatment (Week 44/46)
Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)
The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.
Measured: Baseline and end of treatment (Week 44/46)
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)
FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).
Measured: Baseline and end of treatment (Week 44/46)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start30 Apr 2014
- Primary completion13 Sep 2016
- Study completion19 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106832
- Sponsor's protocol ID
- 15626
- Other IDs
- 2013-004659-19
- Acronym
- RESPIRE 2
- Status last verified
- Sep 2017
- First submitted
- 4 Apr 2014
- Last updated
- 2 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Aksamit T, De Soyza A, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702053. doi: 10.1183/13993003.02053-2017. Print 2018 Jan.
PubMed 29371384Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8.
PubMed 28495619
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.
- ClinicalTrials.gov ID
- NCT02106832
- Acronym / sponsor ID
- RESPIRE 2 / 15626
- Conditions
- Bronchiectasis
- Keywords
- Ciprofloxacin, Dry Powder for Inhalation, Exacerbation, Bronchiectasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- 30 Apr 2014 (actual)
- Primary completion
- 13 Sep 2016 (actual)
- Study completion
- 19 Oct 2016 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Posted 1 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Number of participants with Adverse events will be covered in Adverse Events section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin DPI 28 Days on/off (Cipro 28) | Experimental | Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalationSubjects received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles). |
| Ciprofloxacin DPI 14 Days on/off (Cipro 14) | Experimental | Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalationSubjects received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles). |
| Placebo 28 Days on/off (Placebo 28) | Placebo comparator | Drug: PlaceboSubjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles). |
| Placebo 14 Days on/off (Placebo 14) | Placebo comparator | Drug: PlaceboSubjects received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxacin (BAYQ3939) dry powder for inhalationCiprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment. | Drug | Ciprofloxacin DPI 28 Days on/off (Cipro 28) |
| Ciprofloxacin (BAYQ3939) dry powder for inhalationCiprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment. | Drug | Ciprofloxacin DPI 14 Days on/off (Cipro 14) |
| PlaceboMatching placebo inhaled twice daily intermittently for 28 days on / 28 days off | Drug | Placebo 28 Days on/off (Placebo 28) |
| PlaceboMatching placebo inhaled twice daily intermittently for 14 days on / 14 days off | Drug | Placebo 14 Days on/off (Placebo 14) |
Primary outcome
Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo
Time frame: Up to Week 48
Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo
Time frame: Up to Week 48
Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
7 secondary outcomes
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Time frame: Up to Week 48
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Time frame: Up to Week 48
Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
Time frame: End of treatment (Week 44/46)
Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)
Time frame: Baseline and end of treatment (Week 44/46)
Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
Time frame: End of treatment (Week 44/46)
Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)
Time frame: Baseline and end of treatment (Week 44/46)
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)
Time frame: Baseline and end of treatment (Week 44/46)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29371384Aksamit T, De Soyza A, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702053. doi: 10.1183/13993003.02053-2017. Print 2018 Jan.
- Derived from this study: PubMed 28495619Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
207 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciprofloxacin (BAYQ3939) dry powder for inhalation in people with Bronchiectasis, run by Bayer at 207 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 207 sites in United States, Russia, China, Poland, Germany and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo (time frame: Up to Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02106832, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.