Trial Condition(s):
Bronchiectasis
Ciprofloxacin Dry Powder for Inhalation (DPI) in non-cystic fibrosis bronchiectasis (non–CF BE) (RESPIRE 2)
Bayer Identifier:
15626
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 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
| Locations | |
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Locations Investigative Site Hannover, Germany, 30173 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Berlin, Germany, 10717 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Greenville, United States, 29615 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Peoria, United States, 85381 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site VELDHOVEN, Netherlands, 5500 MB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site ALKMAAR, Netherlands, 1815 JD | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site ASSEN, Netherlands, 9403 RK | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site HELMOND, Netherlands, 5707 HA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 135-720 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 136-705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bucheon, South Korea, 420-717 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Daejeon, South Korea, 301-723 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Incheon Gwangyeogsi,, South Korea, 403-720 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 100-032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 130-872 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Vilnius, Lithuania, LT-08661 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Klaipeda, Lithuania, LT-92288 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Moscow, Russia, 105229 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Yaroslavl, Russia, 150003 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site St. Petersburg, Russia, 196084 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Moscow, Russia, 127015 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Ruse, Bulgaria, 7000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Maltepe, Turkey, 34844 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kampus, Turkey, 07058 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ankara, Turkey, 061100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Praha 2, Czech Republic, 121 11 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site La Jolla, United States, 92037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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Locations Investigative Site Bangkok, Thailand, 10400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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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 Weeks - Cipro 28 vs. Pooled PlaceboTime 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
- Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled PlaceboTime 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 higher score represent a better outcome.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 score represent a better outcome.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)
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