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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008314-40 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period.
Safety issues are addressed in the Adverse Events section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 32.50 mg Ciprofloxacin DPI (BAYQ3939) | Experimental | 32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days |
|
| 48.75 mg Ciprofloxacin DPI (BAYQ3939) | Experimental | 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days |
|
| Matching Placebo for 32.50 mg | Placebo Comparator | Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days |
|
| Matching Placebo for 48.75 mg | Placebo Comparator | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin (Cipro Inhale, BAYQ3939) | Drug | 32.5 mg ciprofloxacin DPI corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30 | FEV1: 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). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used. | Baseline and End of treatment (Day 28-30) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9 | FEV1: 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). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used. |
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Inclusion Criteria:
Subjects, or their legal representative(s), must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
Children (12 - 17 years) or adults >/=18 years
Documented diagnosis Cystic Fibrosis (CF):
Chronic colonization with P. aeruginosa defined as a positive respiratory tract culture (sputum or throat swab) within 12 months prior to screening and at screening (Note: subjects with negative culture at screening can, at the discretion of the investigator, be rescreened at a later date)
Ability to perform reproducible pulmonary function tests
Ability to produce sputum (noninduced)
Stable pulmonary status, FEV1 >/=35% to </=75% (intraindividual variability +/-10% of absolute value). Note: The subject is not eligible for enrollment if the variability results in (or leads to) an FEV1 <35%.
Room air oximetry >/=88% saturation
Off antibiotics (except macrolide) and Cipro (oral) for at least 30 days prior to the administration of study drug for pulmonary exacerbation
Stable regimen of standard CF treatment including chest physiotherapies and exercise regimens should not change during the 30 days prior to the administration of study drug and during the study (including macrolide administration unchanged in the previous 30 days)
Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period
Women who are willing to use an adequate method of contraception for 3 months after receiving the study drug. Adequate methods of contraception include vasectomy or condom use by their partners, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization or oral contraceptive
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85016 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26688732 | Derived | Dorkin HL, Staab D, Operschall E, Alder J, Criollo M. Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis. BMJ Open Respir Res. 2015 Dec 2;2(1):e000100. doi: 10.1136/bmjresp-2015-000100. eCollection 2015. |
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Of all enrolled 486 subjects, 188 had screening failures, the remaining 288 were randomized but 2 subjects (one each in 32.5 mg Ciprofloxacin DPI (Dry Powder for Inhalation) and 48.75 mg Ciprofloxacin DPI groups) did not receive any study drug. A total of 286 subjects received one of the 4 study drug treatments.
The first visit of the first subject was on 05 May 2008 and the last visit of the last subject on 25 Jan 2011. This study was conducted at 73 centers from 8 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | 32.50 mg Ciprofloxacin DPI (BAYQ3939) | 32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days |
| FG001 | 48.75 mg Ciprofloxacin DPI (BAYQ3939) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | 50 mg matching placebo powder formulation twice a day for 28 days |
|
| Ciprofloxacin (Cipro Inhale, BAYQ3939) | Drug | 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation powder twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2) |
|
| Placebo | Drug | 75 mg matching placebo powder formulation twice a day for 28 days (Arm 3 and Arm 4 was introduced after amendment 2) |
|
| Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60). |
| Change From Baseline in P. Aeruginosa Density in the Sputum at Visits 4, 5, 7, 8 and 9 | Density of P. aeruginosa in the sputum is expressed as log10 of colony forming units (CFU)/gram (g). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used. | Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60). |
| Time to First Pulmonary Exacerbation Requiring Intervention | Pulmonary exacerbations: Assessment of pulmonary exacerbation was conducted by the treating physician as part of the physical examination. Pulmonary exacerbation was defined by chest examination findings and any or all of the following symptoms: decreased exercise tolerance, increased cough, increased sputum/cough congestion, school or work absenteeism, increased adventitial sounds on the lung examination, and decreased appetite. | Up to visit 9 (Day 56-60) |
| Change From Baseline in Forced Vital Capacity (FVC) at Visits 4, 5, 7, 8 and 9 | FVC: The maximal volume of air exhaled with maximally forced effort from a maximal inspiration, ie, vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS (body temperature and ambient pressure saturated with water vapor). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used. | Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60). |
| Change From Baseline in Forced Expiratory Flow (FEF 25-75%) at Visits 4, 5, 7, 8 and 9 | FEF 25-75% (also known as the maximum midexpiratory flow [MMEF]): The mean forced expiration flow over the middle half of the forced vital capacity (FVC). It was taken from the blow with the largest sum of FEV1 and FVC. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used. | Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60). |
| Number of Participants Developing Ciprofloxacin-resistant Mucoid P.Aeruginosa Isolates | Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The "susceptible" bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy. | Baseline and up to visit 9 (day 56-60) |
| Number of Participants Developing Ciprofloxacin-resistant Non-mucoid P.Aeruginosa Isolates | Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The "susceptible" bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy. | Baseline and up to visit 9 (day 56-60) |
| Effect of Ciprofloxacin DPI Treatment on Quality of Life Measured by Cystic Fibrosis Quality of Life Questionnaire Revised (CFQ-R), Respiratory Scale | The CF quality of life questionnaire revised (CFQ-R), a validated disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). It is self-administered and consists of 44 items, divided into 12 generic and disease-specific scales. The scale includes physical functioning, role, vitality, emotional functioning, social functioning, body image, eating disturbances, treatment burden, health perceptions, weight, respiratory symptoms, and digestive symptoms. Scale range: 0 to 100 (maximum). Better outcome with higher values. | Baseline and Visit 7 (Day 28-30) and Visit 9 (Day 56 -60) |
| Plasma Concentrations of Ciprofloxacin From Selected Participants During Treatment | Plasma concentrations measured using validated high pressure liquid chromatography-mass specroscopy/mass spectroscopy (HPLC-MS/MS) methods in selected patients at predefined time windows to contribute pharmacokinetic (PK) information for an inter-study population PK evaluation. Sampling window for Plasma: Predose (trough level), <15 min, 2.0 - 2.5 hour, and 4.0 - 7.0 hours after the end of inhalation. Number of samples vary at different time points. | Up to visit 7 (Day 28-30) |
| Sputum Concentrations of Ciprofloxacin From Selected Participants During Treatment | Sputum concentrations measured using validated HPLC-MS/MS methods in selected patients to contribute kinetic information for an inter-study population sputum kinetic evaluation. Number of samples vary at different time points. | Up to visit 7 (Day 28-30) |
| Number of Participants With the Occurrence of Drug Induced Bronchospasms | Bronchospasm reported as adverse event: Bronchospasm defined as >=15% drop in FEV1, and may also include allergic and excercise-induced bronchospasm. Drug-induced bronchospasm: Treatment-emergent bronchospasm was defined as >=15% drop in FEV1 in the ITT/safety population. Note: One of the bronchospasm events was considered a serious adverse event, and it was not included under "other" adverse events. A sum of bronchospasm events was 1+6=7. | Up to visit 9 (Day 56-60) |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Little Rock | Arkansas | 72205 | United States |
| Los Angeles | California | 90027 | United States |
| Los Angeles | California | 90033 | United States |
| Los Angeles | California | 90048 | United States |
| Orange | California | 92868 | United States |
| San Diego | California | 92123-4282 | United States |
| San Francisco | California | 94143 | United States |
| Ventura | California | 93003 | United States |
| Aurora | Colorado | 80045 | United States |
| Hartford | Connecticut | 06102 | United States |
| New Haven | Connecticut | 06520 | United States |
| Jacksonville | Florida | 32207 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32801 | United States |
| Orlando | Florida | 32803 | United States |
| Orlando | Florida | 32806 | United States |
| Augusta | Georgia | 30912-4005 | United States |
| Chicago | Illinois | 60612 | United States |
| Chicago | Illinois | 60614 | United States |
| Glenview | Illinois | 60025 | United States |
| Maywood | Illinois | 60153 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Iowa City | Iowa | 52242-1089 | United States |
| Lexington | Kentucky | 40536-0284 | United States |
| Louisville | Kentucky | 40207 | United States |
| Boston | Massachusetts | 02111 | United States |
| Boston | Massachusetts | 02115 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Kalamazoo | Michigan | 49007 | United States |
| Jackson | Mississippi | 39216 | United States |
| Las Vegas | Nevada | 89107 | United States |
| Livingston | New Jersey | 07039 | United States |
| Long Branch | New Jersey | 07740 | United States |
| Morristown | New Jersey | 07962 | United States |
| Somerville | New Jersey | 08876 | United States |
| Albany | New York | 12208 | United States |
| New Hyde Park | New York | 11040 | United States |
| Valhalla | New York | 10595 | United States |
| Durham | North Carolina | 27710 | United States |
| Akron | Ohio | 44308-1062 | United States |
| Cincinnati | Ohio | 45229-3039 | United States |
| Toledo | Ohio | 43606 | United States |
| Oklahoma City | Oklahoma | 73104 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Tulsa | Oklahoma | 74145 | United States |
| Hershey | Pennsylvania | 17033-0850 | United States |
| Philadelphia | Pennsylvania | 19104-4283 | United States |
| Philadelphia | Pennsylvania | 19134 | United States |
| Charleston | South Carolina | 29425 | United States |
| Knoxville | Tennessee | 37916 | United States |
| Austin | Texas | 78723 | United States |
| San Antonio | Texas | 78212 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Seattle | Washington | 98105 | United States |
| Madison | Wisconsin | 53792 | United States |
| Brisbane | Queensland | 4029 | Australia |
| Chermside | Queensland | 4032 | Australia |
| South Brisbane | Queensland | 4101 | Australia |
| Adelaide | South Australia | 5000 | Australia |
| Clayton | Victoria | 3168 | Australia |
| Parkville | Victoria | 3052 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Hamilton | Ontario | L8S 4J9 | Canada |
| London | Ontario | N6A 5B8 | Canada |
| Montreal | Quebec | H2X 2P4 | Canada |
| Copenhagen | 2100 | Denmark |
| München | Bavaria | 80336 | Germany |
| Frankfurt am Main | Hesse | 60590 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Berlin | State of Berlin | 12200 | Germany |
| Haifa | Israel |
| Jerusalem | Israel |
| Petah Tikva | Israel |
| Tel Litwinsky | Israel |
| Oslo | 0407 | Norway |
| Gothenburg | 416 85 | Sweden |
| Lund | 221 85 | Sweden |
| Uppsala | 751 85 | Sweden |
| Cambridge | Cambridgeshire | CB3 8RE | United Kingdom |
| Southampton | Hampshire | SO16 6YD | United Kingdom |
| Belfast | North Ireland | BT12 7AB | United Kingdom |
| Birmingham | West Midlands | B9 5SS | United Kingdom |
48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days
| FG002 | Matching Placebo for 32.50 mg | Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days |
| FG003 | Matching Placebo for 48.75 mg | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
| Participants Receive Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 32.50 mg Ciprofloxacin DPI (BAYQ3939) | 32.50 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days |
| BG001 | 48.75 mg Ciprofloxacin DPI (BAYQ3939) | 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days |
| BG002 | Matching Placebo for 32.50 mg | Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days |
| BG003 | Matching Placebo for 48.75 mg | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
| 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 |
| ||||||||||||||||
| Forced expiratory volume in 1 second (FEV1) | Mean | Standard Deviation | Percentage of predicted FEV1 |
|
| 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 | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30 | FEV1: 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). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used. | Intent to treat | Posted | Mean | Standard Deviation | Percent of predicted FEV1 | Baseline and End of treatment (Day 28-30) |
|
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| Secondary | Change From Baseline in FEV1 at Visits 4, 5, and Follow-up Visits 8 and 9 | FEV1: 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). This was recorded at the site using a spirometer. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used. | Intent to treat | Posted | Mean | Standard Deviation | Percent of predicted FEV1 | Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60). |
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| Secondary | Change From Baseline in P. Aeruginosa Density in the Sputum at Visits 4, 5, 7, 8 and 9 | Density of P. aeruginosa in the sputum is expressed as log10 of colony forming units (CFU)/gram (g). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used. | Intent to treat | Posted | Mean | Standard Deviation | log10(cfu/g) | Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60). |
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| Secondary | Time to First Pulmonary Exacerbation Requiring Intervention | Pulmonary exacerbations: Assessment of pulmonary exacerbation was conducted by the treating physician as part of the physical examination. Pulmonary exacerbation was defined by chest examination findings and any or all of the following symptoms: decreased exercise tolerance, increased cough, increased sputum/cough congestion, school or work absenteeism, increased adventitial sounds on the lung examination, and decreased appetite. | Intent to treat | Posted | Median | Inter-Quartile Range | Days | Up to visit 9 (Day 56-60) |
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| Secondary | Change From Baseline in Forced Vital Capacity (FVC) at Visits 4, 5, 7, 8 and 9 | FVC: The maximal volume of air exhaled with maximally forced effort from a maximal inspiration, ie, vital capacity performed with a maximally forced expiratory effort expressed in liters at BTPS (body temperature and ambient pressure saturated with water vapor). The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used. | Intent to treat | Posted | Mean | Standard Deviation | Percent of predicted FVC | Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60). |
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| Secondary | Change From Baseline in Forced Expiratory Flow (FEF 25-75%) at Visits 4, 5, 7, 8 and 9 | FEF 25-75% (also known as the maximum midexpiratory flow [MMEF]): The mean forced expiration flow over the middle half of the forced vital capacity (FVC). It was taken from the blow with the largest sum of FEV1 and FVC. The later time point minus baseline, days as planned and the last observation carried forward (LOCF) used. | Intent to treat | Posted | Mean | Standard Deviation | Percent of predicted FEF 25-75% | Baseline and Visit 4 (Day 7-9), Visit 5 (Day 14-16), Visit 7 (Day 28-30), Visit 8 (Day 41-45), and Visit 9 (Day 56 -60). |
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| Secondary | Number of Participants Developing Ciprofloxacin-resistant Mucoid P.Aeruginosa Isolates | Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The "susceptible" bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy. | Intent to treat | Posted | Number | Participants | Baseline and up to visit 9 (day 56-60) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Developing Ciprofloxacin-resistant Non-mucoid P.Aeruginosa Isolates | Susceptibility and resistance assessment of a bacterial isolate was performed using the established Food and Drug Administration (FDA) susceptibility criteria for ciprofloxacin. The susceptibility criteria in mg/L are ≤1 for organisms Enterobacteriaciae, P. aeruginosa, Staphylococcus species and S. pneumoniae. The "susceptible" bacterial species likely responds to typical doses of ciprofloxacin. The resistance criteria for ciprofloxacin in mg/L are ≥4 mg/L for the same organisms. Resistance indicates that the bacteria is less likely to respond to typical doses of ciprofloxacin therapy. | Intent to treat | Posted | Number | Participants | Baseline and up to visit 9 (day 56-60) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effect of Ciprofloxacin DPI Treatment on Quality of Life Measured by Cystic Fibrosis Quality of Life Questionnaire Revised (CFQ-R), Respiratory Scale | The CF quality of life questionnaire revised (CFQ-R), a validated disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents and adults with cystic fibrosis (CF). It is self-administered and consists of 44 items, divided into 12 generic and disease-specific scales. The scale includes physical functioning, role, vitality, emotional functioning, social functioning, body image, eating disturbances, treatment burden, health perceptions, weight, respiratory symptoms, and digestive symptoms. Scale range: 0 to 100 (maximum). Better outcome with higher values. | Intent to treat | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Visit 7 (Day 28-30) and Visit 9 (Day 56 -60) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Ciprofloxacin From Selected Participants During Treatment | Plasma concentrations measured using validated high pressure liquid chromatography-mass specroscopy/mass spectroscopy (HPLC-MS/MS) methods in selected patients at predefined time windows to contribute pharmacokinetic (PK) information for an inter-study population PK evaluation. Sampling window for Plasma: Predose (trough level), <15 min, 2.0 - 2.5 hour, and 4.0 - 7.0 hours after the end of inhalation. Number of samples vary at different time points. | Analysis was not performed due to insufficient data. | Posted | Up to visit 7 (Day 28-30) |
|
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| Secondary | Sputum Concentrations of Ciprofloxacin From Selected Participants During Treatment | Sputum concentrations measured using validated HPLC-MS/MS methods in selected patients to contribute kinetic information for an inter-study population sputum kinetic evaluation. Number of samples vary at different time points. | Analysis was not performed due to insufficient data. | Posted | Up to visit 7 (Day 28-30) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Occurrence of Drug Induced Bronchospasms | Bronchospasm reported as adverse event: Bronchospasm defined as >=15% drop in FEV1, and may also include allergic and excercise-induced bronchospasm. Drug-induced bronchospasm: Treatment-emergent bronchospasm was defined as >=15% drop in FEV1 in the ITT/safety population. Note: One of the bronchospasm events was considered a serious adverse event, and it was not included under "other" adverse events. A sum of bronchospasm events was 1+6=7. | Intent to treat | Posted | Number | participants | Up to visit 9 (Day 56-60) |
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 32.50 mg Ciprofloxacin DPI (BAYQ3939) | 32.5 mg ciprofloxacin DPI (Dry Powder for Inhalation) corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days | 7 | 93 | 67 | 93 | ||
| EG001 | 48.75 mg Ciprofloxacin DPI (BAYQ3939) | 48.75 mg ciprofloxacin DPI corresponding to 75 mg Ciprofloxacin PulmoSphere Inhalation Powder twice a day for 28 days | 17 | 93 | 74 | 93 | ||
| EG002 | Matching Placebo for 32.50 mg | Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days | 7 | 65 | 45 | 65 | ||
| EG003 | Matching Placebo for 48.75 mg | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days | 3 | 35 | 25 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Distal intestinal obstruction syndrome | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Exercise tolerance decreased | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Product taste abnormal | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
The agreed point of publication is 12-18 months after database lock at the earliest. Bayer will have 30-45 days to review publications, and may request an additional publication delay of up to 60 days to allow for filing a Patent Application (if applicable). No publication of single center data should be done prior of publication if multi-center data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| OG003 | Matching Placebo for 48.75 mg | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
|
|
Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
|
|
|
| Matching Placebo for 48.75 mg |
Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
|
|
| OG003 | Matching Placebo for 48.75 mg | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
|
|
| OG003 | Matching Placebo for 48.75 mg | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
|
|
| OG003 | Matching Placebo for 48.75 mg | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
|
|
| OG003 | Matching Placebo for 48.75 mg | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
|
|
Inhalation of placebo powder formulation matching 32.50 mg ciprofloxacin DPI twice a day for 28 days |
| OG003 | Matching Placebo for 48.75 mg | Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
|
|
| OG003 |
| Matching Placebo for 48.75 mg |
Inhalation of placebo powder formulation matching 48.75 mg ciprofloxacin DPI twice a day for 28 days |
|
|