Trial Condition(s):
Bronchiectasis
Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) (RESPIRE 1)
Bayer Identifier:
15625
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patients with a proven and documented diagnosis of non Cystic Fibrosis (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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Exeter, United Kingdom, EX2 5DW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Belfast, United Kingdom, BT12 7AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Plymouth, United Kingdom, PL6 8DH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torbay, United Kingdom, TQ2 7AA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, United Kingdom, SW3 6NP | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Manchester, United Kingdom, M23 9LT | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pisa, Italy, 56124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pavia, Italy, 27040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Benevento, Italy, 82037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varese, Italy, 21049 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bari, Italy, 70020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cagliari, Italy, 09126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ADELAIDE, Australia, 5041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30173 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10717 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 10969 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sant Boi de Llobregat, Spain, 08830 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Geesthacht, Germany, 21502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koblenz, Germany, 56068 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 12203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site CLERMONT FERRAND, France, 63000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTPELLIER, France, 34059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Terrassa, Spain, 08221 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pontevedra, Spain, 36071 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site L'Hospitalet, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pozuelo de Alarcón, Spain, 28223 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oviedo, Spain, 33006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Elda, Spain, 03600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hellerup, Denmark, 2900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Naestved, Denmark, 4700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 811-1394 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sakai, Japan, 591-8555 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koshi, Japan, 861-1196 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nakagun, Japan, 319-1113 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiyose, Japan, 204-8585 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsusaka, Japan, 515-8544 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tsu, Japan, 514-1101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamamatsu, Japan, 434-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toon, Japan, 791-0281 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mitaka, Japan, 181-8611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankston, Australia, 3199 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toorak Gardens, Australia, 5065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Box Hill, Australia, 3128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Woolloongabba, Australia, 4102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Woodville, Australia, 5011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NIMES, France, 30900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULON, France, 83000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cairns, Australia, 4870 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Parkville, Australia, 3050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site PRAHRAN, Australia, 3181 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kogarah, Australia, 2217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Christchurch, New Zealand, 8011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wellington, New Zealand, 6021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamilton, New Zealand, 3240 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Auckland, New Zealand, 1051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Auckland, New Zealand, 1640 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tauranga, New Zealand, 3110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wellington, New Zealand, 6021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dunedin, New Zealand | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90048 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lawrenceville, United States, 30046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winter Park, United States, 32789 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Richmond, United States, 23225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tacoma, United States, 98405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chesterfield, United States, 63017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Michigan City, United States, 46360 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Phoenix, United States, 85006-2611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hazard, United States, 41701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torrance, United States | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ventura, United States, 93003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tyler, United States, 75708-3154 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Abingdon, United States, 24210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19140 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Waterbury, United States, 06708-2513 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Summit, United States, 07901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Flagstaff, United States, 86001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site McKinney, United States, 75069 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Scottsdale, United States, 85258 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fort Smith, United States, 72901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Marietta, United States, 30060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Washington, United States, 20007-2197 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Farmington, United States, 06030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Hyde Park, United States, 11042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charleston, United States, 29425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orlando, United States, 32803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kingwood, United States, 77339 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97239-3011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jasper, United States, 35501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rehovot, Israel, 7610001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ashkelon, Israel, 7827804 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Afula, Israel, 1834111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3436212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beer Sheva, Israel, 8410101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Aviv, Israel, 6423906 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cambridge, United Kingdom, CB23 3RE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Londonderry, United Kingdom, BT47 6SB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trieste, Italy, 34149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Weston, United States, 33331 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Catania, Italy, 95123 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vicente López, Argentina, 1638 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1425DES | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Godoy Cruz, Argentina, 5501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Verona, Italy, 37126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Murdoch, Australia, 6150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riga, Latvia, LV-1002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Daugavpils, Latvia, LV-5410 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kraslava, Latvia, 5601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jurmala, Latvia, LV-2010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riga, Latvia, LV-1011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riga, Latvia, LV-1038 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Daugavpils, Latvia, LV-5403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Talsu, Latvia, 3201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riga, Latvia, LV-1001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Celebration, United States, 34747 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Celebration, United States, 34747 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shrewsbury, United Kingdom, SY3 8XQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cáceres, Spain, 10003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava, Slovakia, 821 06 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Presov, Slovakia, 080 01 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 22767 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cottbus, Germany, 03050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Neu-Isenburg, Germany, 63263 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Frankfurt, Germany, 60389 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aarhus C, Denmark, 8000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roskilde, Denmark, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Spokane, United States, 99202-1334 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dundee, United Kingdom, DD1 9SY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fort Worth, United States, 76104 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Time to First Exacerbation Event Within 48 WeeksTime 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.Timeframe: Up to Week 48
Secondary Outcome
- Number of participants with exacerbation events with worsening of at least three signs/symptoms over 48 weeksFor 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.Timeframe: Up to Week 48
- Number of participants with exacerbation events with worsening of at least one sign/symptom over 48 weeksFor this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.Timeframe: Up to Week 48
- 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.Timeframe: 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)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.Timeframe: Baseline and end of treatment (Week 44/46)
- 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.Timeframe: 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)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.Timeframe: 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)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).Timeframe: Baseline and end of treatment (Week 44/46)
Additional Information
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