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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004208-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
Number of participants with Adverse events will be covered in Adverse Events section.
The statistical analysis tests for the efficacy variables will be performed hierarchically. The comparisons ciprofloxacin DPI vs. pooled placebo (according to statistical analysis plan defined for FDA registration) will be performed in parallel for the regimen 28 days on/off and 14 days on/off.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin DPI 28 Days on/off (Cipro 28) | Experimental | Participants 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). |
|
| Ciprofloxacin DPI 14 Days on/off (Cipro 14) | Experimental | Participants 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). |
|
| Placebo 28 Days on/off (Placebo 28) | Placebo Comparator | Participants 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). |
|
| Placebo 14 Days on/off (Placebo 14) | Placebo Comparator | Participants 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin DPI (BAYQ3939) | Drug | Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper | Alabama | 35501 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29371383 | Derived | De Soyza A, Aksamit T, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702052. doi: 10.1183/13993003.02052-2017. Print 2018 Jan. | |
| 28495619 |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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Overall 902 participants were screened, of them 486 were screen failures, and 416 were randomized, out of which 414 participants were assigned to the treatment. One participant from Ciprofloxacin 14 Days on/off group and one participant from Placebo 28 Days on/off group did not receive the study treatment after initial screening.
Study was conducted at 124 study centers in 14 countries (Argentina, Australia, Denmark, France, Germany, Israel, Italy, Japan, Latvia, New Zealand, Slovakia, Spain, UK and US) between 02 May 2013 (first subject first visit) and 09 March 2016 (last subject last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | Participants 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device. |
|
| 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. |
| 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. | 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. | 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. | 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. | 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). | Baseline and end of treatment (Week 44/46) |
| Flagstaff |
| Arizona |
| 86001 |
| United States |
| Phoenix | Arizona | 85006-2611 | United States |
| Scottsdale | Arizona | 85258 | United States |
| Fort Smith | Arkansas | 72901 | United States |
| Los Angeles | California | 90048 | United States |
| Torrance | California | United States |
| Ventura | California | 93003 | United States |
| Farmington | Connecticut | 06030 | United States |
| Waterbury | Connecticut | 06708-2513 | United States |
| Washington D.C. | District of Columbia | 20007-2197 | United States |
| Celebration | Florida | 34747 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803 | United States |
| Weston | Florida | 33331 | United States |
| Winter Park | Florida | 32789 | United States |
| Lawrenceville | Georgia | 30046 | United States |
| Marietta | Georgia | 30060 | United States |
| Chicago | Illinois | 60637 | United States |
| Michigan City | Indiana | 46360 | United States |
| Hazard | Kentucky | 41701 | United States |
| Chesterfield | Missouri | 63017 | United States |
| Summit | New Jersey | 07901 | United States |
| New Hyde Park | New York | 11042 | United States |
| New York | New York | 10016 | United States |
| Portland | Oregon | 97239-3011 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Charleston | South Carolina | 29425 | United States |
| Fort Worth | Texas | 76104 | United States |
| Houston | Texas | 77030 | United States |
| Houston | Texas | 77043 | United States |
| Kingwood | Texas | 77339 | United States |
| McKinney | Texas | 75069 | United States |
| Tyler | Texas | 75708-3154 | United States |
| Abingdon | Virginia | 24210 | United States |
| Richmond | Virginia | 23225 | United States |
| Spokane | Washington | 99202-1334 | United States |
| Tacoma | Washington | 98405 | United States |
| Buenos Aires | Ciudad Auton. de Buenos Aires | C1425DES | Argentina |
| Godoy Cruz | Mendoza Province | 5501 | Argentina |
| Vicente López | 1638 | Argentina |
| Woolloongabba | Queensland | 4102 | Australia |
| Adelaide | South Australia | 5000 | Australia |
| Adelaide | South Australia | 5041 | Australia |
| Woodville | South Australia | 5011 | Australia |
| Parkville | Victoria | 3050 | Australia |
| Prahran | Victoria | 3181 | Australia |
| Murdoch | Western Australia | 6150 | Australia |
| Box Hill | 3128 | Australia |
| Cairns | 4870 | Australia |
| Frankston | 3199 | Australia |
| Kogarah | 2217 | Australia |
| Toorak Gardens | 5065 | Australia |
| Aarhus C | 8000 | Denmark |
| Hellerup | 2900 | Denmark |
| Næstved | 4700 | Denmark |
| Roskilde | 4000 | Denmark |
| Clermont-Ferrand | 63000 | France |
| Montpellier | 34059 | France |
| Nîmes | 30900 | France |
| Toulon | 83000 | France |
| Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Cottbus | Brandenburg | 03050 | Germany |
| Frankfurt am Main | Hesse | 60389 | Germany |
| Neu-Isenburg | Hesse | 63263 | Germany |
| Hanover | Lower Saxony | 30173 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Koblenz | Rhineland-Palatinate | 56068 | Germany |
| Geesthacht | Schleswig-Holstein | 21502 | Germany |
| Jena | Thuringia | 07740 | Germany |
| Berlin | 10717 | Germany |
| Berlin | 10969 | Germany |
| Berlin | 12203 | Germany |
| Hamburg | 22767 | Germany |
| Afula | 1834111 | Israel |
| Ashkelon | 7827804 | Israel |
| Beersheba | 8410101 | Israel |
| Haifa | 3109601 | Israel |
| Haifa | 3436212 | Israel |
| Jerusalem | 9112001 | Israel |
| Petah Tikva | 4941492 | Israel |
| Ramat Gan | 5262000 | Israel |
| Rehovot | 7610001 | Israel |
| Tel Aviv | 6423906 | Israel |
| Bari | Apulia | 70020 | Italy |
| Benevento | Campania | 82037 | Italy |
| Trieste | Friuli Venezia Giulia | 34149 | Italy |
| Rome | Lazio | 00168 | Italy |
| Pavia | Lombardy | 27040 | Italy |
| Varese | Lombardy | 21049 | Italy |
| Cagliari | Sardinia | 09126 | Italy |
| Catania | Sicily | 95123 | Italy |
| Pisa | Tuscany | 56124 | Italy |
| Verona | Veneto | 37126 | Italy |
| Tōon | Ehime | 791-0281 | Japan |
| Nakagun | Ibaraki | 319-1113 | Japan |
| Kōshi | Kumamoto | 861-1196 | Japan |
| Matsusaka | Mie-ken | 515-8544 | Japan |
| Tsu | Mie-ken | 514-1101 | Japan |
| Sakai | Osaka | 591-8555 | Japan |
| Hamamatsu | Shizuoka | 434-8511 | Japan |
| Kiyose | Tokyo | 204-8585 | Japan |
| Mitaka | Tokyo | 181-8611 | Japan |
| Fukuoka | 811-1394 | Japan |
| Daugavpils | LV-5403 | Latvia |
| Daugavpils | LV-5410 | Latvia |
| Jūrmala | LV-2010 | Latvia |
| Krāslava | 5601 | Latvia |
| Riga | LV-1001 | Latvia |
| Riga | LV-1002 | Latvia |
| Riga | LV-1011 | Latvia |
| Riga | LV-1038 | Latvia |
| Talsu | 3201 | Latvia |
| Auckland | 1051 | New Zealand |
| Auckland | 1640 | New Zealand |
| Christchurch | 8011 | New Zealand |
| Dunedin | New Zealand |
| Hamilton | 3240 | New Zealand |
| Tauranga | 3110 | New Zealand |
| Wellington | 6021 | New Zealand |
| Bratislava | 821 06 | Slovakia |
| Prešov | 080 01 | Slovakia |
| Santiago de Compostela | A Coruña | 15706 | Spain |
| Elda | Alicante | 03600 | Spain |
| Badalona | Barcelona | 08916 | Spain |
| L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Sant Boi de Llobregat | Barcelona | 08830 | Spain |
| Terrassa | Barcelona | 08221 | Spain |
| Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Oviedo | Principality of Asturias | 33006 | Spain |
| Barcelona | 08036 | Spain |
| Barcelona | 08041 | Spain |
| Cáceres | 10003 | Spain |
| Madrid | 28006 | Spain |
| Madrid | 28034 | Spain |
| Madrid | 28040 | Spain |
| Pontevedra | 36071 | Spain |
| Valencia | 46017 | Spain |
| Valencia | 46026 | Spain |
| Cambridge | Cambridgeshire | CB23 3RE | United Kingdom |
| Exeter | Devon | EX2 5DW | United Kingdom |
| Plymouth | Devon | PL6 8DH | United Kingdom |
| Torbay | Devon | TQ2 7AA | United Kingdom |
| Dundee | Dundee City | DD1 9SY | United Kingdom |
| Belfast | North Ireland | BT12 7AB | United Kingdom |
| Shrewsbury | Shropshire | SY3 8XQ | United Kingdom |
| Newcastle upon Tyne | Tyne and Wear | NE7 7DN | United Kingdom |
| London | SW3 6NP | United Kingdom |
| Londonderry | BT47 6SB | United Kingdom |
| Manchester | M23 9LT | United Kingdom |
| Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8. |
| FG001 |
| Ciprofloxacin DPI 14 Days on/Off (Cipro 14) |
Participants 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). |
| FG002 | Placebo 28 Days on/Off (Placebo 28) | Participants 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). |
| FG003 | Placebo 14 Days on/Off (Placebo 14) | Participants 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). |
| Participants Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | Participants 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). |
| BG001 | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | Participants 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). |
| BG002 | Placebo 28 Days on/Off (Placebo 28) | Participants 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). |
| BG003 | Placebo 14 Days on/Off (Placebo 14) | Participants 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). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score | 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 baseline measure, the symptoms component score was reported. | Participants with data available for this measure at baseline. | Mean | Standard Deviation | Score on a scale |
| ||||||||
| Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score | 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 baseline measure, the respiratory symptoms domain score was reported. | Participants with data available for this measure at baseline. | Mean | Standard Deviation | Score on a scale |
| ||||||||
| Forced Expiratory Volume in One Second (FEV1) | FEV1 was 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). | Mean | Standard Deviation | Liter |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full analysis set (FAS) included participants who were randomized. | Posted | Median | 97.5% Confidence Interval | Days | Up to Week 48 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set (FAS) included participants who were randomized. | Posted | Number | Participants | Up to Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set (FAS) included participants who were randomized. | Posted | Number | Participants | Up to Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set (FAS) included participants who were randomized. | Posted | Number | Percentage of Participants | End of treatment (Week 44/46) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS with participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and end of treatment (Week 44/46) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set (FAS) included participants who were randomized. | Posted | Number | Percentage of Participants | End of treatment (Week 44/46) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS with participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and end of treatment (Week 44/46) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | FAS with participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Liter | Baseline and end of treatment (Week 44/46) |
|
From start of study treatment up to 30 days after the last study drug administration.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ciprofloxacin DPI 28 Days on/Off (Cipro 28) | Participants received ciprofloxacin (BAYQ3939) 32.5 mg corresponding to 50 mg DPI 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 active cycles). | 29 | 141 | 74 | 141 | ||
| EG001 | Ciprofloxacin DPI 14 Days on/Off (Cipro 14) | Participants 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). | 23 | 136 | 83 | 136 | ||
| EG002 | Pooled Placebo | Participants received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively). | 32 | 137 | 62 | 137 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Retinal vasculitis | Eye disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Strangulated hernia | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Gastroenteritis clostridial | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pathogen resistance | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Complications of transplant surgery | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urethral stricture traumatic | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (18.1) | Non-systematic Assessment |
| |
| Influenza A virus test positive | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Fracture nonunion | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Thyroid cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cerebral atrophy | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Prostatic haemorrhage | Reproductive system and breast disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Pyometra | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Aspergillus test positive | Investigations | MedDRA (18.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Non-systematic Assessment |
|
Bayer acknowledges and accepts the interest in the noncommercial scientific publication of Results. In a multicenter study the PIs will not make any publication of the results before the first multi-center publication. Proposed publication/presentation shall be provided to Bayer at least 60 days prior to the intended submission or presentation of the publication in order to allow Bayer to review it. Any difference of opinion shall be discussed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayer.com |
| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
|
|
|
|
|
The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% CI was calculated by using Cox proportional hazards model by comparison of Cipro 14/Pooled Placebo reporting groups. P-value was analysed using Wald-type test. |
| Wald-type test |
| 0.0005 |
| Hazard Ratio (HR) |
| 0.5333 |
| 2-Sided |
| 97.5 |
| 0.3568 |
| 0.7971 |
| Superiority or Other |
|
|
|
|
|
Participants 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 or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
|
|
| OG002 | Placebo 28 Days on/Off (Placebo 28) | Participants 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). |
| OG003 | Placebo 14 Days on/Off (Placebo 14) | Participants 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). |
|
|
|
|
| OG002 | Placebo 28 Days on/Off (Placebo 28) | Participants 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). |
| OG003 | Placebo 14 Days on/Off (Placebo 14) | Participants 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). |
|
|
Participants 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).
| OG003 | Placebo 14 Days on/Off (Placebo 14) | Participants 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). |
|
|