Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
NCT ID: NCT02106832
Last Updated: 2017-10-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
521 participants
INTERVENTIONAL
2014-04-30
2016-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ciprofloxacin DPI 28 Days on/off (Cipro 28)
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).
Ciprofloxacin (BAYQ3939) dry powder for inhalation
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 DPI 14 Days on/off (Cipro 14)
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).
Ciprofloxacin (BAYQ3939) dry powder for inhalation
Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.
Placebo 28 Days on/off (Placebo 28)
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).
Placebo
Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off
Placebo 14 Days on/off (Placebo 14)
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).
Placebo
Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off
Interventions
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Ciprofloxacin (BAYQ3939) dry powder for inhalation
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 inhalation
Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.
Placebo
Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off
Placebo
Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off
Eligibility Criteria
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Inclusion Criteria
* Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks
Exclusion Criteria
* Active allergic bronchopulmonary aspergillosis
* Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis
* Primary diagnosis of Chronic obstructive pulmonary disease (COPD)
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Peoria, Arizona, United States
Fountain Valley, California, United States
La Jolla, California, United States
Long Beach, California, United States
Newport Beach, California, United States
San Diego, California, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Skokie, Illinois, United States
Olathe, Kansas, United States
Rochester, Minnesota, United States
Brooklyn, New York, United States
Mineola, New York, United States
Asheville, North Carolina, United States
Portland, Oregon, United States
Doylestown, Pennsylvania, United States
Greenville, South Carolina, United States
Edinburg, Texas, United States
Tyler, Texas, United States
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Capital Federal, Ciudad Auton. de Buenos Aires, Argentina
Godoy Cruz, Mendoza Province, Argentina
Córdoba, , Argentina
Vicente López, , Argentina
Kogarah, New South Wales, Australia
New Lambton Heights, New South Wales, Australia
Adelaide, South Australia, Australia
Adelaide, South Australia, Australia
Parkville, Victoria, Australia
Murdoch, Western Australia, Australia
Perth, Western Australia, Australia
Graz, , Austria
Salzburg, , Austria
Belo Horizonte, Minas Gerais, Brazil
Recife, Pernambuco, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
Porto Alegre, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Gabrovo, , Bulgaria
Kozloduy, , Bulgaria
Lovech, , Bulgaria
Razgrad, , Bulgaria
Rousse, , Bulgaria
Sevlievo, , Bulgaria
Sliven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Hohehot, Inner Mongolia, China
Suzhou, Jiangsu, China
Wuxi, Jiangsu, China
Nanchang, Jiangxi, China
Shenyang, Liaoning, China
Yinchuan, Ningxia, China
Chengdu, Sichuan, China
Beijing, , China
Beijing, , China
Chongqing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Brno, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Treuenbrietzen, Brandenburg, Germany
Frankfurt am Main, Hesse, Germany
Neu-Isenburg, Hesse, Germany
Hanover, Lower Saxony, Germany
Hanover, Lower Saxony, Germany
Gelsenkirchen, North Rhine-Westphalia, Germany
Leipzig, Saxony, Germany
Bad Berka, Thuringia, Germany
Jena, Thuringia, Germany
Berlin, , Germany
Berlin, , Germany
Hamburg, , Germany
Hong Kong, , Hong Kong
Kowloon, , Hong Kong
New Territories, , Hong Kong
Shatin, , Hong Kong
Daugavpils, , Latvia
Daugavpils, , Latvia
Jūrmala, , Latvia
Krāslava, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Talsi, , Latvia
Klaipėda, , Lithuania
Vilnius, , Lithuania
Alkmaar, , Netherlands
Assen, , Netherlands
Groningen, , Netherlands
Helmond, , Netherlands
Maastricht, , Netherlands
Sittard-Geleen, , Netherlands
Veldhoven, , Netherlands
City of San Fernando, , Philippines
Manila, , Philippines
Manila, , Philippines
Quezon City, , Philippines
Quezon City, , Philippines
Bielsko-Biala, , Poland
Częstochowa, , Poland
Gorzów Wielkopolski, , Poland
Grudziądz, , Poland
Katowice, , Poland
Kielce, , Poland
Kielce, , Poland
Kielce, , Poland
Krakow, , Poland
Ksawerów, , Poland
Mrozy, , Poland
Ostrowiec Świętokrzyski, , Poland
Rzeszów, , Poland
Warsaw, , Poland
Angra do Heroísmo, Azores, Portugal
Vila Nova de Gaia, Porto District, Portugal
Faro, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Bragadiru, , Romania
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Codlea, , Romania
Constanța, , Romania
Iași, , Romania
Ploieşti, , Romania
Timișoara, , Romania
Arkhangelsk, , Russia
Chelyabinsk, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Tomsk, , Russia
Ufa, , Russia
Voronezh, , Russia
Yaroslavl, , Russia
Belgrade, , Serbia
Belgrade, , Serbia
Čačak, , Serbia
Kamenitz, , Serbia
Knez-Selo, , Serbia
Kragujevac, , Serbia
Sombor, , Serbia
Valjevo, , Serbia
Bratislava, , Slovakia
Prešov, , Slovakia
Johannesburg, Gauteng, South Africa
eManzimtoti, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Daejeon, Daejeon Gwang''yeogsi, South Korea
Bucheon-si, Gyeonggido, South Korea
Incheon Gwangyeogsi,, Incheon Gwang''yeogsi, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Daegu, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Chiayi City, , Taiwan
Kaohsiung City, , Taiwan
New Taipei City, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Khon Kaen, , Thailand
NakhonRatchasima, , Thailand
Phitsanulok, , Thailand
Udon Thani, , Thailand
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Balcalı, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kampus, , Turkey (Türkiye)
Konya, , Turkey (Türkiye)
Maltepe, , Turkey (Türkiye)
Mersin, , Turkey (Türkiye)
Pendik, , Turkey (Türkiye)
Samsun, , Turkey (Türkiye)
Şehitkamil, , Turkey (Türkiye)
Countries
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References
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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.
Aksamit 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.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2013-004659-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15626
Identifier Type: -
Identifier Source: org_study_id