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

September 4, 2017 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

521

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5003DCE
      • Vicente López, Argentina, 1638
    • Ciudad Auton. de Buenos Aires
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1425DES
      • Capital Federal, Ciudad Auton. de Buenos Aires, Argentina, 1425
    • Mendoza
      • Godoy Cruz, Mendoza, Argentina, 5501
  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
      • New Lambton Heights, New South Wales, Australia, 2305
    • South Australia
      • Adelaide, South Australia, Australia, 5042
      • Adelaide, South Australia, Australia, 5041
    • Victoria
      • Parkville, Victoria, Australia, 3050
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
      • Perth, Western Australia, Australia, 6009
  • Austria
      • Graz, Austria, 8036
      • Salzburg, Austria, 5020
  • Brazil
      • Porto Alegre, Brazil, 90035-074
      • Sao Paulo, Brazil, 05403-900
      • Sao Paulo, Brazil, 01244-030
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50920640
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Porto Alegre, Rio Grande do Sul, Brazil, 90880-480
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 04266-010
  • Bulgaria
      • Gabrovo, Bulgaria, 5300
      • Kozloduy, Bulgaria, 3320
      • Lovech, Bulgaria, 5500
      • Razgrad, Bulgaria, 7200
      • Ruse, Bulgaria, 7000
      • Sevlievo, Bulgaria, 5400
      • Sliven, Bulgaria, 8800
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1000
      • Stara Zagora, Bulgaria, 6000
  • China
      • Beijing, China, 100029
      • Beijing, China, 100144
      • Chongqing, China, 400042
      • Shanghai, China, 200032
      • Shanghai, China, 200040
      • Shanghai, China, 200433
    • Fujian
      • Fuzhou, Fujian, China, 350025
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
    • Inner Mongolia
      • Hohehot, Inner Mongolia, China, 010050
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
      • Wuxi, Jiangsu, China, 214023
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
    • Liaoning
      • Shenyang, Liaoning, China, 110004
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
    • Sichuan
      • Chengdu, Sichuan, China, 610041
  • Czechia
      • Brno, Czechia, 625 00
      • Prague 4, Czechia, 140 46
      • Praha 2, Czechia, 121 11
      • Praha 8, Czechia, 180 81
  • Germany
      • Berlin, Germany, 14059
      • Berlin, Germany, 10717
      • Hamburg, Germany, 22767
    • Brandenburg
      • Treuenbrietzen, Brandenburg, Germany, 14929
    • Hessen
      • Frankfurt, Hessen, Germany, 60389
      • Neu-Isenburg, Hessen, Germany, 63263
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
      • Hannover, Niedersachsen, Germany, 30173
    • Nordrhein-Westfalen
      • Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
    • Sachsen
      • Leipzig, Sachsen, Germany, 04357
    • Thüringen
      • Bad Berka, Thüringen, Germany, 99437
      • Jena, Thüringen, Germany, 07740
  • Hong Kong
      • Hong Kong, Hong Kong
      • Kowloon, Hong Kong
      • New Territories, Hong Kong
      • Shatin, Hong Kong
  • Korea, Republic of
      • Daegu, Korea, Republic of, 42415
      • Incheon, Korea, Republic of, 21565
      • Seoul, Korea, Republic of, 03080
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 130-872
      • Seoul, Korea, Republic of, 136-705
      • Seoul, Korea, Republic of, 100-032
    • Daejeon Gwang''yeogsi
      • Daejeon, Daejeon Gwang''yeogsi, Korea, Republic of, 301-723
    • Gyeonggido
      • Bucheon, Gyeonggido, Korea, Republic of, 420-717
    • Incheon Gwang''yeogsi
      • Incheon Gwangyeogsi,, Incheon Gwang''yeogsi, Korea, Republic of, 403-720
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 135-720
  • Latvia
      • Daugavpils, Latvia, LV-5403
      • Daugavpils, Latvia, LV-5410
      • Jurmala, Latvia, LV-2010
      • Kraslava, Latvia, 5601
      • Riga, Latvia, LV-1002
      • Riga, Latvia, LV-1038
      • Riga, Latvia, LV-1001
      • Riga, Latvia, LV-1011
      • 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, 25-734
      • Kielce, Poland, 25-035
      • 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
      • Faro, Portugal, 8000-386
      • Lisboa, Portugal, 1769-001
      • Lisboa, Portugal, 1649-035
    • Porto
      • Vila Nova de Gaia, Porto, Portugal, 4434-502
    • Região Autónoma dos Açores
      • Angra do Heroísmo, Região Autónoma dos Açores, Portugal, 9701-856
  • Romania
      • Bragadiru, Romania, 077025
      • Brasov, Romania, 500086
      • Bucharest, Romania, 030303
      • Bucharest, Romania, 011461
      • Bucharest, Romania, 010457
      • 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, 129090
      • Moscow, Russian Federation, 127015
      • Nizhny Novgorod, Russian Federation, 603035
      • Novosibirsk, Russian Federation, 630087
      • Novosibirsk, Russian Federation, 630047
      • Novosibirsk, Russian Federation, 630075
      • St. Petersburg, Russian Federation, 196084
      • St. Petersburg, Russian Federation, 194295
      • St. Petersburg, Russian Federation, 194356
      • 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
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2092
    • Kwazulu-Natal
      • Amanzimtoti, Kwazulu-Natal, South Africa, 4127
    • Western Cape
      • 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
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
    • 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
    • Florida
      • Kissimmee, Florida, United States, 34741
      • Miami, Florida, United States, 33126
      • Sarasota, Florida, United States, 34239
      • Tampa, Florida, United States, 33613
    • Georgia
      • Decatur, Georgia, United States, 30033
    • Illinois
      • Skokie, Illinois, United States, 60076
    • Kansas
      • Olathe, Kansas, United States, 66061
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New York
      • Brooklyn, New York, United States, 11229
      • Mineola, New York, United States, 11501
    • North Carolina
      • Asheville, North Carolina, United States, 28801
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
    • South Carolina
      • Greenville, South Carolina, United States, 29615
    • Texas
      • Edinburg, Texas, United States, 78539
      • Tyler, Texas, United States, 75708-3154

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.
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.
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 dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.
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
Drug: Placebo
Matching placebo inhaled twice daily intermittently for 14 days on / 14 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 28 days on / 28 days off
Drug: Placebo
Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Week 48
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.
Up to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to Week 48
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.
Up to Week 48
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.
End of treatment (Week 44/46)
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.
Baseline and end of treatment (Week 44/46)
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.
End of treatment (Week 44/46)
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.
Baseline and end of treatment (Week 44/46)
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).
Baseline and end of treatment (Week 44/46)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2014

Primary Completion (ACTUAL)

September 13, 2016

Study Completion (ACTUAL)

October 19, 2016

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (ESTIMATE)

April 8, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15626
  • 2013-004659-19 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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