check_circleStudy Completed

Bronchiectasis

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
  • - 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


  • - 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
April 2014 - October 2016
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Ciprofloxacin DPI (BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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.
    date_rangeTime Frame:
    Up to Week 48
    enhanced_encryption
    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.
    date_rangeTime Frame:
    Up to Week 48
    enhanced_encryption
    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.
    date_rangeTime Frame:
    Up to Week 48
    enhanced_encryption
    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.
    date_rangeTime Frame:
    Up to Week 48
    enhanced_encryption
    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.
    date_rangeTime Frame:
    End of treatment (Week 44/46)
    enhanced_encryption
    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.
    date_rangeTime Frame:
    Baseline and end of treatment (Week 44/46)
    enhanced_encryption
    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.
    date_rangeTime Frame:
    End of treatment (Week 44/46)
    enhanced_encryption
    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.
    date_rangeTime Frame:
    Baseline and end of treatment (Week 44/46)
    enhanced_encryption
    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).
    date_rangeTime Frame:
    Baseline and end of treatment (Week 44/46)
    enhanced_encryption
    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
4