non-CF bronchiectasis MedDRA version: 19.0 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age at least 18 years; 2) Proven and documented diagnosis of non-CF idiopathic or post-infectious BE by CT scan (conventional high resolution CT is considered the standard) including 2 or more lobes and dilated airways compatible with BE at initial diagnosis 3) Positive culture from an adequate sputum sample for Pseudomonas aeruginosa, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Stenotrophomonas maltophilia or Burkholderia cepacia obtained at screening and with history =2 documented exacerbations in the past 12 months. 4) Stable pulmonary status as indicated by FEV1 (percent of predicted) ?30% and =65 years) yes F.1.3.1 Number of subjects for this age range 246
Exclusion criteria
Exclusion criteria: 1) FEV1 =90% predicted (post-bronchodilator); 2) Active allergic bronchopulmonary aspergillosis (ABPA); 3) Active and actively-treated non-tuberculosis mycobacterial (NTM) infection or tuberculosis; 4) Diagnosis of common variable immunodeficiency (CVID); 5) Recent significant hemoptysis (?300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period); 6) Primary diagnosis of COPD; 7) Known CF and / or documented chronic bronchial asthma; 8) Administration of any investigational drug within 4 weeks before screening; 9) Medical history of allergies to quinolones or fluoroquinolones; 10) Women who are pregnant, lactating, or in whom pregnancy cannot be excluded; 11) History of tendon disorders related to quinolone treatment; 12) History of myasthenia gravis; 13) Concomitant administration of tizanidine while on study drug; 14) Systemic or inhaled antibiotic treatment for any indication within 4 weeks prior to the administration of study drug; except for chronic macrolide use (see section 6.9). 15) Systemic corticosteroids at >10 mg/day prednisolone equivalent for >14 days within 4 weeks prior to the administration of study drug; 16) If participating in or has participated in other investigational interventional studies within the previous4 weeks before screening; 17) Subjects with any other conditions (specifically those which are addressed in the warnings and precautions section of the IB) or clinically relevant laboratory findings that the investigator defines as not appropriate for enrollment of a subject into the study 18) Previous assignment to treatment in this study (randomized in Study 15626); subjects who have participated in RESPIRE 1 will not be enrolled in RESPIRE 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are • To evaluate the efficacy of ciprofloxacin DPI administered 2 times a day (BID) intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study treatment / 14 days off study treatment to prolong the time to first pulmonary exacerbation requiring an intervention with systemic antibiotics (oral/i.v.) in subjects with non–CF BE within 48 weeks after start of treatment (as agreed with the US FDA [Food and Drug Administration]). • To evaluate the efficacy of ciprofloxacin DPI administered 2 times a day (BID) intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study treatment / 14 days off study treatment in reducing the frequency of pulmonary exacerbation requiring an intervention with systemic antibiotics (oral/i.v.) in subjects with non–CF BE within 48 weeks after start of treatment. ;Secondary Objective: The secondary objectives of this study are: - To assess the frequency of pulmonary exacerbations in subjects with non–CF BE. For this secondary exacerbation events are defined as eventswith systemic antibiotic use and worsening of at least one sign/symptom ; - To assess pathogen eradication and acquisition of new pathogenic organisms not present at baseline; - To assess the safety and tolerability of different long term regimens of ciprofloxacin DPI; - To assess the improvement of quality of life by Saint George’s Respiratory Questionnaire; - To assess the improvement of quality of life by Quality of Life-Bronchiectasis (QOL–B) questionnaire's respiratory symptom domain; - To assess changes in lung function as measured by changes in forced expiratory volume in 1 second (FEV1). ;Primary end point(s): The primary efficacy variables are the time to first pulmonary exacerbation requiring an intervention with systemic antibiotics within 48 weeks after start of treatment (for US NDA[New Drug Application]) and the frequency of exacerbations requirin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives of this study are: • To assess frequency of exacerbations over 48 weeks (US NDA) / time to first exacerbation within 48 weeks after start of treatment (EU MAA); • To assess frequency of pulmonary exacerbation in subjects with non–CF BE. For this secondary endpoint exacerbation events are defined as events with systemic antibiotic use and worsening of at least one sign/symptom; • To assess pathogen eradication and acquisition of new pathogenic organisms not present at baseline; • To assess the safety and tolerability of different long term regimens of ciprofloxacin DPI; • To assess the improvement of quality of life by Saint George's Respiratory Questionnaire; • To assess the improvement of quality of life by Quality of Life respiratory symptom domain Questionnaire (QoL-B); • To assess changes in lung function as measured by changes in forced expiratory volume in 1 second (FEV1).;Timepoint(s) of evaluation of this end point: Confirmatory analyses for pathogen eradication, occurrence of new pathogens and lung function and SGRQ will be evaluated at end of the on-treatment part of the 6th cycle for subjects in the 28 day on/off regimen, at end of the on-treatment part of the 12th cycle for subjects in the 14 day on/off regimen. | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Czech Republic, Germany, Hong Kong, Hungary, Korea, Republic of, Latvia, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Taiwan, Thailand, Turkey, United States
Contacts
Public ContactBayer Clin. Trials Contact CTP Team
Bayer AG
Outcome results
None listed