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Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) (RESPIRE 2)

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ClinicalTrials.gov Identifier: NCT02106832
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : September 1, 2017
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation Drug: Placebo Phase 3

Detailed Description:
Number of participants with Adverse events will be covered in Adverse Events section.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 30, 2014
Actual Primary Completion Date : September 13, 2016
Actual Study Completion Date : October 19, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Drug: 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.

Experimental: 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).
Drug: 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 Comparator: 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).
Drug: Placebo
Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off

Placebo Comparator: 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).
Drug: Placebo
Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks [ Time Frame: Up to Week 48 ]
    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.

  2. Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks [ Time Frame: Up to Week 48 ]
    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.

  3. Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46) [ Time Frame: 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.

  4. 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) ]
    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.

  5. Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46) [ Time Frame: 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.

  6. 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) ]
    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.

  7. 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) ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106832


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Locations
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United States, Arizona
Peoria, Arizona, United States, 85381
United States, California
Fountain Valley, California, United States, 90708
La Jolla, California, United States, 92037
Long Beach, California, United States, 90813
Newport Beach, California, United States, 92663
San Diego, California, United States, 92120
United States, Florida
Kissimmee, Florida, United States, 34741
Miami, Florida, United States, 33126
Sarasota, Florida, United States, 34239
Tampa, Florida, United States, 33613
United States, Georgia
Decatur, Georgia, United States, 30033
United States, Illinois
Skokie, Illinois, United States, 60076
United States, Kansas
Olathe, Kansas, United States, 66061
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New York
Brooklyn, New York, United States, 11229
Mineola, New York, United States, 11501
United States, North Carolina
Asheville, North Carolina, United States, 28801
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Doylestown, Pennsylvania, United States, 18901
United States, South Carolina
Greenville, South Carolina, United States, 29615
United States, Texas
Edinburg, Texas, United States, 78539
Tyler, Texas, United States, 75708-3154
Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1425DES
Capital Federal, Ciudad Auton. de Buenos Aires, Argentina, 1425
Godoy Cruz, Mendoza, Argentina, 5501
Córdoba, Argentina, X5003DCE
Vicente López, Argentina, 1638
Australia, New South Wales
Kogarah, New South Wales, Australia, 2217
New Lambton Heights, New South Wales, Australia, 2305
Australia, South Australia
Adelaide, South Australia, Australia, 5041
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Murdoch, Western Australia, Australia, 6150
Perth, Western Australia, Australia, 6009
Austria
Graz, Austria, 8036
Salzburg, Austria, 5020
Brazil
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Recife, Pernambuco, Brazil, 50920640
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Porto Alegre, Rio Grande do Sul, Brazil, 90880-480
São Paulo, Sao Paulo, Brazil, 04266-010
Porto Alegre, Brazil, 90035-074
Sao Paulo, Brazil, 01244-030
Sao Paulo, Brazil, 05403-900
Bulgaria
Gabrovo, Bulgaria, 5300
Kozloduy, Bulgaria, 3320
Lovech, Bulgaria, 5500
Razgrad, Bulgaria, 7200
Ruse, Bulgaria, 7000
Sevlievo, Bulgaria, 5400
Sliven, Bulgaria, 8800
Sofia, Bulgaria, 1000
Sofia, Bulgaria, 1606
Stara Zagora, Bulgaria, 6000
China, Fujian
Fuzhou, Fujian, China, 350025
China, Guangdong
Guangzhou, Guangdong, China, 510120
China, Inner Mongolia
Hohehot, Inner Mongolia, China, 010050
China, Jiangsu
Suzhou, Jiangsu, China, 215006
Wuxi, Jiangsu, China, 214023
China, Jiangxi
Nanchang, Jiangxi, China, 330006
China, Liaoning
Shenyang, Liaoning, China, 110004
China, Ningxia
Yinchuan, Ningxia, China, 750004
China, Sichuan
Chengdu, Sichuan, China, 610041
China
Beijing, China, 100029
Beijing, China, 100144
Chongqing, China, 400042
Shanghai, China, 200032
Shanghai, China, 200040
Shanghai, China, 200433
Czechia
Brno, Czechia, 625 00
Prague 4, Czechia, 140 46
Praha 2, Czechia, 121 11
Praha 8, Czechia, 180 81
Germany
Treuenbrietzen, Brandenburg, Germany, 14929
Frankfurt, Hessen, Germany, 60389
Neu-Isenburg, Hessen, Germany, 63263
Hannover, Niedersachsen, Germany, 30173
Hannover, Niedersachsen, Germany, 30625
Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
Leipzig, Sachsen, Germany, 04357
Bad Berka, Thüringen, Germany, 99437
Jena, Thüringen, Germany, 07740
Berlin, Germany, 10717
Berlin, Germany, 14059
Hamburg, Germany, 22767
Hong Kong
Hong Kong, Hong Kong
Kowloon, Hong Kong
New Territories, Hong Kong
Shatin, Hong Kong
Korea, Republic of
Daejeon, Daejeon Gwang''yeogsi, Korea, Republic of, 301-723
Bucheon, Gyeonggido, Korea, Republic of, 420-717
Incheon Gwangyeogsi,, Incheon Gwang''yeogsi, Korea, Republic of, 403-720
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 135-720
Daegu, Korea, Republic of, 42415
Incheon, Korea, Republic of, 21565
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 100-032
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 130-872
Seoul, Korea, Republic of, 136-705
Latvia
Daugavpils, Latvia, LV-5403
Daugavpils, Latvia, LV-5410
Jurmala, Latvia, LV-2010
Kraslava, Latvia, 5601
Riga, Latvia, LV-1001
Riga, Latvia, LV-1002
Riga, Latvia, LV-1011
Riga, Latvia, LV-1038
Talsi, Latvia, LV-3201
Lithuania
Klaipeda, Lithuania, LT-92288
Vilnius, Lithuania, LT-08661
Netherlands
Alkmaar, Netherlands, 1815 JD
Assen, Netherlands, 9403 RK
Groningen, Netherlands, 9728 NT
Helmond, Netherlands, 5707 HA
Maastricht, Netherlands, 6229 HX
Sittard-Geleen, Netherlands, 6162 BG
Veldhoven, Netherlands, 5500 MB
Philippines
City of San Fernando, Philippines, 2000
Manila, Philippines, 1000
Manila, Philippines, 1012
Quezon City, Philippines, NCR 1100
Quezon City, Philippines, NCR 1104
Poland
Bielsko-Biala, Poland, 43-300
Czestochowa, Poland, 42-200
Gorzow Wielkopolski, Poland, 66-400
Grudziadz, Poland, 86-300
Katowice, Poland, 40-954
Kielce, Poland, 25-035
Kielce, Poland, 25-734
Kielce, Poland, 25-751
Krakow, Poland, 31-455
Ksawerow, Poland, 95-054
Mrozy, Poland, 05-320
Ostrowiec Swietokrzyski, Poland, 27-400
Rzeszow, Poland, 35-301
Warszawa, Poland, 01-868
Portugal
Vila Nova de Gaia, Porto, Portugal, 4434-502
Angra do Heroísmo, Região Autónoma dos Açores, Portugal, 9701-856
Faro, Portugal, 8000-386
Lisboa, Portugal, 1649-035
Lisboa, Portugal, 1769-001
Romania
Bragadiru, Romania, 077025
Brasov, Romania, 500086
Bucharest, Romania, 010457
Bucharest, Romania, 011461
Bucharest, Romania, 030303
Bucharest, Romania, 050159
Codlea, Romania, 505100
Constanta, Romania, 900002
Iasi, Romania, 700141
Ploiesti, Romania, 100184
Timisoara, Romania, 300310
Russian Federation
Arkhangelsk, Russian Federation, 163001
Chelyabinsk, Russian Federation, 454076
Moscow, Russian Federation, 105229
Moscow, Russian Federation, 115682
Moscow, Russian Federation, 127015
Moscow, Russian Federation, 129090
Nizhny Novgorod, Russian Federation, 603035
Novosibirsk, Russian Federation, 630047
Novosibirsk, Russian Federation, 630075
Novosibirsk, Russian Federation, 630087
St. Petersburg, Russian Federation, 194295
St. Petersburg, Russian Federation, 194356
St. Petersburg, Russian Federation, 196084
Tomsk, Russian Federation, 634063
Ufa, Russian Federation, 450071
Voronezh, Russian Federation, 394066
Yaroslavl, Russian Federation, 150003
Serbia
Belgrade, Serbia, 11000
Belgrade, Serbia, 11080
Cacak, Serbia, 32000
Knez Selo, Serbia, 18204
Kragujevac, Serbia, 34000
Sombor, Serbia, 25000
Sremska Kamenica, Serbia, 21204
Valjevo, Serbia, 14000
Slovakia
Bratislava, Slovakia, 821 06
Presov, Slovakia, 080 01
South Africa
Johannesburg, Gauteng, South Africa, 2092
Amanzimtoti, Kwazulu-Natal, South Africa, 4127
Cape Town, Western Cape, South Africa, 7500
Cape Town, Western Cape, South Africa, 7764
Taiwan
Chiayi, Taiwan, 613
Kaohsiung, Taiwan, 807
New Taipei City,, Taiwan, 23561
Taichung, Taiwan, 40447
Taipei, Taiwan, 10002
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Chiangmai, Thailand, 50200
Khon Kaen, Thailand, 40002
NakhonRatchasima, Thailand, 30000
Phitsanulok, Thailand, 65000
Udonthani, Thailand, 41000
Turkey
Ankara, Turkey, 061100
Ankara, Turkey, 06110
Balcali, Turkey, 01330
Izmir, Turkey, 35040
Kampus, Turkey, 07058
Konya, Turkey, 42080
Maltepe, Turkey, 34844
Mersin, Turkey, 33343
Pendik, Turkey, 34890
Samsun, Turkey, 55139
Sehitkamil, Turkey, 27310
Sponsors and Collaborators
Bayer
Novartis
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02106832     History of Changes
Other Study ID Numbers: 15626
2013-004659-19 ( EudraCT Number )
First Posted: April 8, 2014    Key Record Dates
Results First Posted: September 1, 2017
Last Update Posted: October 2, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Ciprofloxacin
Dry Powder for Inhalation
Exacerbation
Bronchiectasis
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors