Study Completed

Bronchiectasis

Bayer Identifier:

15625

ClinicalTrials.gov Identifier:

NCT01764841

EudraCT Number:

2011-004208-39

EU CT Number:

Not Available

Ciprofloxacin dry powder for inhalation 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

416

Trial Dates

May 2013 - March 2016

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Ciprofloxacin DPI (BAYQ3939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Newcastle Upon Tyne, NE7 7DN, United Kingdom
Completed		Exeter, EX2 5DW, United Kingdom
Completed		Belfast, BT12 7AB, United Kingdom
Completed		Plymouth, PL6 8DH, United Kingdom
Completed		Torbay, TQ2 7AA, United Kingdom
Completed		London, SW3 6NP, United Kingdom
Terminated		Manchester, M23 9LT, United Kingdom
Completed		Pisa, 56124, Italy
Completed		Pavia, 27040, Italy
Completed		Benevento, 82037, Italy
Completed		Varese, 21049, Italy
Terminated		Bari, 70020, Italy
Completed		Cagliari, 09126, Italy
Completed		ADELAIDE, 5041, Australia
Completed		Hannover, 30625, Germany
Completed		Hannover, 30173, Germany
Completed		Berlin, 10717, Germany
Completed		Berlin, 10969, Germany
Terminated		Heidelberg, 69126, Germany
Completed		Barcelona, 08036, Spain
Completed		Sant Boi de Llobregat, 08830, Spain
Completed		Geesthacht, 21502, Germany
Completed		Koblenz, 56068, Germany
Completed		Berlin, 12203, Germany
Completed		CLERMONT FERRAND, 63000, France
Completed		MONTPELLIER, 34059, France
Terminated		Terrassa, 08221, Spain
Terminated		Pontevedra, 36071, Spain
Completed		L'Hospitalet, 08907, Spain
Completed		Santiago de Compostela, 15706, Spain
Completed		Barcelona, 08041, Spain
Terminated		Madrid, 28034, Spain
Completed		Madrid, 28006, Spain
Terminated		Badalona, 08916, Spain
Completed		Pozuelo de Alarcón, 28223, Spain
Completed		Oviedo, 33006, Spain
Completed		Elda, 03600, Spain
Terminated		Valencia, 46017, Spain
Completed		Hellerup, 2900, Denmark
Completed		Naestved, 4700, Denmark
Completed		Fukuoka, 811-1394, Japan
Completed		Sakai, 591-8555, Japan
Completed		Koshi, 861-1196, Japan
Completed		Nakagun, 319-1113, Japan
Completed		Kiyose, 204-8585, Japan
Completed		Matsusaka, 515-8544, Japan
Completed		Tsu, 514-1101, Japan
Completed		Hamamatsu, 434-8511, Japan
Completed		Toon, 791-0281, Japan
Completed		Mitaka, 181-8611, Japan
Completed		Frankston, 3199, Australia
Completed		Adelaide, 5000, Australia
Completed		Toorak Gardens, 5065, Australia
Completed		Box Hill, 3128, Australia
Completed		Woolloongabba, 4102, Australia
Completed		Woodville, 5011, Australia
Completed		NIMES, 30900, France
Completed		TOULON, 83000, France
Completed		Cairns, 4870, Australia
Completed		Parkville, 3050, Australia
Completed		PRAHRAN, 3181, Australia
Completed		Kogarah, 2217, Australia
Completed		Christchurch, 8011, New Zealand
Completed		Wellington, 6021, New Zealand
Completed		Hamilton, 3240, New Zealand
Completed		Auckland, 1051, New Zealand
Completed		Auckland, 1640, New Zealand
Completed		Tauranga, 3110, New Zealand
Terminated		Wellington, 6021, New Zealand
Completed		Dunedin, New Zealand
Completed		Los Angeles, 90048, United States
Completed		Lawrenceville, 30046, United States
Completed		Valencia, 46026, Spain
Completed		Winter Park, 32789, United States
Completed		Richmond, 23225, United States
Completed		Tacoma, 98405, United States
Completed		Chesterfield, 63017, United States
Completed		Michigan City, 46360, United States
Completed		Phoenix, 85006-2611, United States
Completed		Hazard, 41701, United States
Completed		Miami, 33136, United States
Terminated		Torrance, United States
Terminated		Houston, 77030, United States
Terminated		Ventura, 93003, United States
Completed		Tyler, 75708-3154, United States
Terminated		New York, 10016, United States
Completed		Abingdon, 24210, United States
Terminated		Philadelphia, 19140, United States
Completed		Waterbury, 06708-2513, United States
Terminated		Summit, 07901, United States
Completed		Flagstaff, 86001, United States
Terminated		McKinney, 75069, United States
Terminated		Scottsdale, 85258, United States
Completed		Fort Smith, 72901, United States
Terminated		Marietta, 30060, United States
Completed		Washington, 20007-2197, United States
Terminated		Farmington, 06030, United States
Completed		New Hyde Park, 11042, United States
Completed		Charleston, 29425, United States
Completed		Orlando, 32803, United States
Completed		Kingwood, 77339, United States
Completed		Portland, 97239-3011, United States
Completed		Houston, 77043, United States
Terminated		Jasper, 35501, United States
Terminated		Philadelphia, 19104, United States
Completed		Rehovot, 7610001, Israel
Completed		Ashkelon, 7827804, Israel
Completed		Jerusalem, 9112001, Israel
Completed		Ramat Gan, 5262000, Israel
Completed		Afula, 1834111, Israel
Completed		Haifa, 3109601, Israel
Completed		Haifa, 3436212, Israel
Completed		Beer Sheva, 8410101, Israel
Completed		Tel Aviv, 6423906, Israel
Completed		Petah Tikva, 4941492, Israel
Completed		Cambridge, CB23 3RE, United Kingdom
Completed		Londonderry, BT47 6SB, United Kingdom
Completed		Trieste, 34149, Italy
Completed		Roma, 00168, Italy
Terminated		Weston, 33331, United States
Terminated		Chicago, 60637, United States
Completed		Catania, 95123, Italy
Terminated		Vicente López, 1638, Argentina
Completed		Buenos Aires, C1425DES, Argentina
Completed		Godoy Cruz, 5501, Argentina
Completed		Verona, 37126, Italy
Completed		Murdoch, 6150, Australia
Completed		Riga, LV-1002, Latvia
Completed		Daugavpils, LV-5410, Latvia
Completed		Kraslava, 5601, Latvia
Terminated		Jurmala, LV-2010, Latvia
Completed		Riga, LV-1011, Latvia
Completed		Riga, LV-1038, Latvia
Completed		Daugavpils, LV-5403, Latvia
Completed		Talsu, 3201, Latvia
Completed		Riga, LV-1001, Latvia
Terminated		Celebration, 34747, United States
Completed		Celebration, 34747, United States
Completed		Shrewsbury, SY3 8XQ, United Kingdom
Completed		Madrid, 28040, Spain
Terminated		Cáceres, 10003, Spain
Completed		Bratislava, 821 06, Slovakia
Completed		Presov, 080 01, Slovakia
Completed		Hamburg, 22767, Germany
Completed		Cottbus, 03050, Germany
Completed		Jena, 07740, Germany
Completed		Neu-Isenburg, 63263, Germany
Completed		Frankfurt, 60389, Germany
Terminated		Aarhus C, 8000, Denmark
Completed		Roskilde, 4000, Denmark
Terminated		Spokane, 99202-1334, United States
Completed		Dundee, DD1 9SY, United Kingdom
Completed		Fort Worth, 76104, United States

Primary Outcome

Time to First Exacerbation Event Within 48 Weeks
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 smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.
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 scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.
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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