check_circleStudy Completed
Bronchiectasis
Bayer Identifier:
15626
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Ciprofloxacin Dry Powder for Inhalation (DPI) in non-cystic fibrosis bronchiectasis (non–CF BE)
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
521Trial Dates
April 2014 - October 2016Phase
Phase 3Could I Receive a placebo
YesProducts
Ciprofloxacin DPI (BAYQ3939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Hannover, 30173, Germany | |
Completed | Berlin, 10717, Germany | |
Completed | Greenville, 29615, United States | |
Terminated | Peoria, 85381, United States | |
Completed | VELDHOVEN, 5500 MB, Netherlands | |
Completed | ALKMAAR, 1815 JD, Netherlands | |
Completed | ASSEN, 9403 RK, Netherlands | |
Completed | HELMOND, 5707 HA, Netherlands | |
Completed | Seoul, 135-720, Korea, Republic Of | |
Completed | Seoul, 136-705, Korea, Republic Of | |
Completed | Seoul, 120-752, Korea, Republic Of | |
Completed | Bucheon, 420-717, Korea, Republic Of | |
Completed | Daejeon, 301-723, Korea, Republic Of | |
Completed | Incheon Gwangyeogsi,, 403-720, Korea, Republic Of | |
Completed | Seoul, 100-032, Korea, Republic Of | |
Completed | Seoul, 130-872, Korea, Republic Of | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Vilnius, LT-08661, Lithuania | |
Completed | Klaipeda, LT-92288, Lithuania | |
Completed | Moscow, 105229, Russia | |
Completed | Yaroslavl, 150003, Russia | |
Completed | St. Petersburg, 196084, Russia | |
Completed | Moscow, 127015, Russia | |
Terminated | Nizhny Novgorod, 603035, Russia | |
Completed | Moscow, 115682, Russia | |
Completed | St. Petersburg, 194356, Russia | |
Completed | Daegu, 42415, Korea, Republic Of | |
Completed | Incheon, 21565, Korea, Republic Of | |
Completed | San Diego, 92120, United States | |
Terminated | Mineola, 11501, United States | |
Terminated | Kissimmee, 34741, United States | |
Completed | KRAKOW, 31-455, Poland | |
Completed | Bielsko-Biala, 43-300, Poland | |
Terminated | GRUDZIADZ, 86-300, Poland | |
Completed | MROZY, 05-320, Poland | |
Completed | Ruse, 7000, Bulgaria | |
Completed | Sofia, 1606, Bulgaria | |
Completed | Lovech, 5500, Bulgaria | |
Completed | Razgrad, 7200, Bulgaria | |
Completed | Ruse, 7000, Bulgaria | |
Completed | Kozloduy, 3320, Bulgaria | |
Completed | Porto Alegre, 90035-074, Brazil | |
Terminated | Sao Paulo, 05403-900, Brazil | |
Terminated | Sao Paulo, 01244-030, Brazil | |
Completed | Taipei, 10002, Taiwan | |
Completed | New Taipei City,, 23561, Taiwan | |
Terminated | Chiayi, 613, Taiwan | |
Completed | Moscow, 129090, Russia | |
Terminated | GRONINGEN, 9728 NT, Netherlands | |
Terminated | Cape Town, 7500, South Africa | |
Terminated | Johannesburg, 2092, South Africa | |
Completed | Cape Town, 7764, South Africa | |
Completed | Amanzimtoti, 4127, South Africa | |
Terminated | Sofia, 1000, Bulgaria | |
Completed | Sevlievo, 5400, Bulgaria | |
Completed | Sliven, 8800, Bulgaria | |
Completed | Graz, 8036, Austria | |
Terminated | Belo Horizonte, 30150-221, Brazil | |
Terminated | Porto Alegre, 90610-000, Brazil | |
Terminated | São Paulo, 04266-010, Brazil | |
Terminated | Recife, 50920640, Brazil | |
Completed | Porto Alegre, 90880-480, Brazil | |
Completed | Hong Kong, Hong Kong | |
Completed | Kowloon, Hong Kong | |
Completed | New Territories, Hong Kong | |
Completed | Shatin, Hong Kong | |
Completed | Berlin, 14059, Germany | |
Completed | Gelsenkirchen, 45879, Germany | |
Completed | Leipzig, 04357, Germany | |
Completed | Bad Berka, 99437, Germany | |
Completed | Long Beach, 90813, United States | |
Terminated | Tampa, 33613, United States | |
Terminated | Decatur, 30033, United States | |
Completed | Kaohsiung, 807, Taiwan | |
Completed | Taichung, 40447, Taiwan | |
Terminated | Pendik, 34890, Turkey | |
Completed | Maltepe, 34844, Turkey | |
Completed | Kampus, 07058, Turkey | |
Completed | Ankara, 061100, Turkey | |
Completed | Sehitkamil, 27310, Turkey | |
Completed | Balcali, 01330, Turkey | |
Completed | Rochester, 55905, United States | |
Completed | Sarasota, 34239, United States | |
Completed | Skokie, 60076, United States | |
Completed | Ufa, 450071, Russia | |
Completed | Voronezh, 394066, Russia | |
Completed | St. Petersburg, 194295, Russia | |
Terminated | Edinburg, 78539, United States | |
Completed | Brooklyn, 11229, United States | |
Terminated | Asheville, 28801, United States | |
Completed | Doylestown, 18901, United States | |
Terminated | Gorzow Wielkopolski, 66-400, Poland | |
Completed | Ostrowiec Swietokrzyski, 27-400, Poland | |
Completed | Samsun, 55139, Turkey | |
Completed | Praha 2, 121 11, Czech Republic | |
Completed | Prague 4, 140 46, Czech Republic | |
Completed | Praha 8, 180 81, Czech Republic | |
Terminated | Brno, 625 00, Czech Republic | |
Completed | Olathe, 66061, United States | |
Completed | Newport Beach, 92663, United States | |
Terminated | La Jolla, 92037, United States | |
Terminated | Bangkok, 10700, Thailand | |
Terminated | Chiangmai, 50200, Thailand | |
Completed | NakhonRatchasima, 30000, Thailand | |
Completed | Khon Kaen, 40002, Thailand | |
Completed | Bangkok, 10400, Thailand | |
Completed | Perth, 6009, Australia | |
Completed | New Lambton Heights, 2305, Australia | |
Completed | Adelaide, 5042, Australia | |
Completed | Godoy Cruz, 5501, Argentina | |
Completed | Vicente López, 1638, Argentina | |
Terminated | Buenos Aires, C1425DES, Argentina | |
Completed | Córdoba, X5003DCE, Argentina | |
Terminated | Capital Federal, 1425, Argentina | |
Completed | Bucharest, 011461, Romania | |
Completed | Iasi, 700141, Romania | |
Completed | Lisboa, 1769-001, Portugal | |
Terminated | Angra do Heroísmo, 9701-856, Portugal | |
Completed | Lisboa, 1649-035, Portugal | |
Terminated | Faro, 8000-386, Portugal | |
Completed | Vila Nova de Gaia, 4434-502, Portugal | |
Terminated | Salzburg, 5020, Austria | |
Completed | Stara Zagora, 6000, Bulgaria | |
Completed | Warszawa, 01-868, Poland | |
Terminated | Udonthani, 41000, Thailand | |
Completed | Suzhou, 215006, China | |
Completed | Shenyang, 110004, China | |
Completed | Wuxi, 214023, China | |
Terminated | Fuzhou, 350025, China | |
Terminated | Shanghai, 200032, China | |
Completed | Chongqing, 400042, China | |
Completed | Chengdu, 610041, China | |
Completed | Nanchang, 330006, China | |
Completed | Yinchuan, 750004, China | |
Terminated | Guangzhou, 510120, China | |
Completed | Hohehot, 010050, China | |
Completed | shanghai, 200433, China | |
Completed | Beijing, 100029, China | |
Terminated | Shanghai, 200040, China | |
Completed | Beijing, 100144, China | |
Completed | Novosibirsk, 630047, Russia | |
Completed | Novosibirsk, 630087, Russia | |
Completed | Miami, 33126, United States | |
Terminated | Treuenbrietzen, 14929, Germany | |
Terminated | Rzeszow, 35-301, Poland | |
Completed | St. Petersburg, 194356, Russia | |
Completed | Chelyabinsk, 454076, Russia | |
Terminated | Talsi, LV-3201, Latvia | |
Completed | Riga, LV-1001, Latvia | |
Completed | Riga, LV-1002, Latvia | |
Completed | Daugavpils, LV-5410, Latvia | |
Completed | Kraslava, 5601, Latvia | |
Completed | Jurmala, LV-2010, Latvia | |
Completed | Riga, LV-1011, Latvia | |
Completed | Riga, LV-1038, Latvia | |
Completed | Daugavpils, LV-5403, Latvia | |
Completed | Ploiesti, 100184, Romania | |
Completed | Bucharest, 030303, Romania | |
Completed | Bucharest, 050159, Romania | |
Completed | Brasov, 500086, Romania | |
Completed | Codlea, 505100, Romania | |
Completed | Constanta, 900002, Romania | |
Terminated | Bucharest, 010457, Romania | |
Completed | Timisoara, 300310, Romania | |
Completed | Bragadiru, 077025, Romania | |
Completed | Gabrovo, 5300, Bulgaria | |
Completed | Phitsanulok, 65000, Thailand | |
Completed | Ankara, 06110, Turkey | |
Completed | Konya, 42080, Turkey | |
Completed | Kielce, 25-751, Poland | |
Completed | Czestochowa, 42-200, Poland | |
Terminated | Kielce, 25-734, Poland | |
Completed | Katowice, 40-954, Poland | |
Completed | Bucharest, 050159, Romania | |
Completed | Mersin, 33343, Turkey | |
Completed | Izmir, 35040, Turkey | |
Completed | Cacak, 32000, Serbia | |
Completed | Valjevo, 14000, Serbia | |
Completed | Kragujevac, 34000, Serbia | |
Completed | Knez Selo, 18204, Serbia | |
Completed | Belgrade, 11000, Serbia | |
Completed | Belgrade, 11000, Serbia | |
Completed | Belgrade, 11000, Serbia | |
Terminated | Belgrade, 11080, Serbia | |
Completed | Sombor, 25000, Serbia | |
Completed | Arkhangelsk, 163001, Russia | |
Terminated | Presov, 080 01, Slovakia | |
Completed | Bratislava, 821 06, Slovakia | |
Completed | Novosibirsk, 630075, Russia | |
Completed | Tomsk, 634063, Russia | |
Terminated | Kielce, 25-035, Poland | |
Completed | Ksawerow, 95-054, Poland | |
Completed | Sittard-Geleen, 6162 BG, Netherlands | |
Terminated | Maastricht, 6229 HX, Netherlands | |
Completed | Manila, 1000, Philippines | |
Completed | Quezon City, NCR 1100, Philippines | |
Completed | City of San Fernando, 2000, Philippines | |
Completed | Quezon City, NCR 1104, Philippines | |
Completed | Manila, 1012, Philippines | |
Completed | Sremska Kamenica, 21204, Serbia | |
Terminated | Treuenbrietzen, 14929, Germany | |
Completed | Jena, 07740, Germany | |
Terminated | Hamburg, 22767, Germany | |
Completed | Neu-Isenburg, 63263, Germany | |
Completed | Frankfurt, 60389, Germany | |
Completed | Hannover, 30625, Germany | |
Completed | Guangzhou, 510120, China | |
Completed | Adelaide, 5041, Australia | |
Completed | Parkville, 3050, Australia | |
Completed | Kogarah, 2217, Australia | |
Completed | Murdoch, 6150, Australia | |
Terminated | Tyler, 75708-3154, United States | |
Terminated | Portland, 97239, United States | |
Terminated | Guangzhou, 510120, China | |
Terminated | Fountain Valley, 90708, United States |
Primary Outcome
- Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled PlaceboTime 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.date_rangeTime Frame:Up to Week 48enhanced_encryptionNoSafety Issue:
- Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled PlaceboTime 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.date_rangeTime Frame:Up to Week 48enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with exacerbation events with worsening of at least three signs/symptoms over 48 weeksFor 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.date_rangeTime Frame:Up to Week 48enhanced_encryptionNoSafety Issue:
- Number of participants with exacerbation events with worsening of at least one sign/symptom over 48 weeksFor this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.date_rangeTime Frame:Up to Week 48enhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:End of treatment (Week 44/46)enhanced_encryptionNoSafety Issue:
- 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 higher score represent a better outcome.date_rangeTime Frame:Baseline and end of treatment (Week 44/46)enhanced_encryptionNoSafety Issue:
- 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.date_rangeTime Frame:End of treatment (Week 44/46)enhanced_encryptionNoSafety Issue:
- 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 score represent a better outcome.date_rangeTime Frame:Baseline and end of treatment (Week 44/46)enhanced_encryptionNoSafety Issue:
- 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).date_rangeTime Frame:Baseline and end of treatment (Week 44/46)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4Additional Information
Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Click here to find results for studies related to Bayer Healthcare products.