Study Completed

Bronchiectasis

Bayer Identifier:

15626

ClinicalTrials.gov Identifier:

NCT02106832

EudraCT Number:

2013-004659-19

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

Both

Age

18 - N/A

Trial summary

Enrollment Goal

521

Trial Dates

April 2014 - October 2016

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Ciprofloxacin DPI (BAYQ3939)

Accepts Healthy Volunteer

Where 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 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.
Time Frame:
Up to Week 48
Safety Issue:
No
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.
Time Frame:
Up to Week 48
Safety Issue:
No

Secondary Outcome

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.
Time Frame:
Up to Week 48
Safety Issue:
No
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.
Time Frame:
Up to Week 48
Safety Issue:
No
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.
Time Frame:
End of treatment (Week 44/46)
Safety Issue:
No
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.
Time Frame:
Baseline and end of treatment (Week 44/46)
Safety Issue:
No
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.
Time Frame:
End of treatment (Week 44/46)
Safety Issue:
No
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.
Time Frame:
Baseline and end of treatment (Week 44/46)
Safety Issue:
No
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).
Time Frame:
Baseline and end of treatment (Week 44/46)
Safety Issue:
No

Trial design

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.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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