Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cyst... | NCT02106832

ID	Type	Description	Link
2013-004659-19	EudraCT Number

Name	Class
Novartis	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ciprofloxacin DPI 28 Days on/off (Cipro 28)	Experimental	Subjects 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).	Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation
Ciprofloxacin DPI 14 Days on/off (Cipro 14)	Experimental	Subjects 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).	Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation
Placebo 28 Days on/off (Placebo 28)	Placebo Comparator	Subjects 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).	Drug: Placebo
Placebo 14 Days on/off (Placebo 14)	Placebo Comparator	Subjects 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).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ciprofloxacin (BAYQ3939) dry powder for inhalation	Drug	Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.

Measure	Description	Time Frame
Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo	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
Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo	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

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

PubMed Identifier	Type	Citation	Retractions
29371384	Derived	Aksamit T, De Soyza A, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 2: 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):1702053. doi: 10.1183/13993003.02053-2017. Print 2018 Jan.
28495619

Label	URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.	View source

ID	Title	Description
FG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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).

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00059.3± 14.2 BG00160.4± 13.7 BG00260.6± 13.7 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00092 BG00196 BG002

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.

Mean

Standard Deviation

Score on a scale

Title

Denominators

Categories

Title	Measurements
	BG00060.75± 20.61 BG001

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.

Mean

Standard Deviation

Score on a scale

Title

Denominators

Categories

Title	Measurements
	BG00050.14± 19.07 BG001

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

Title

Denominators

Categories

Title	Measurements
	BG0001.569± 0.602 BG001

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 - Cipro 28 vs. Pooled Placebo

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

99.9% Confidence Interval

Days

Up to Week 48

ID	Title	Description
OG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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).
OG001	Pooled Placebo	Subjects 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).

Units	Counts
Participants	OG000171 OG001174

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)Value cannot be estimated due to censored data. OG001NA(211 to NA)Value cannot be estimated due to censored data.

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The hazard ratio for time to first exacerbation event within 48 weeks and 99.9% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.	Wald-type test		0.0511		Hazard Ratio (HR)	0.7062			2-Sided	99.9	0.3928	1.2698					Superiority or Other

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

Count of Participants

Participants

Up to Week 48

ID	Title	Description
OG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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).
OG001	Ciprofloxacin DPI 14 Days on/Off (Cipro 14)	Subjects 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).
OG002	Pooled Placebo	Subjects 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).

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

Count of Participants

Participants

Up to Week 48

ID	Title	Description
OG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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).
OG001	Ciprofloxacin DPI 14 Days on/Off (Cipro 14)	Subjects 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).
OG002	Pooled Placebo	Subjects 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).

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)

ID	Title	Description
OG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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).
OG001	Ciprofloxacin DPI 14 Days on/Off (Cipro 14)	Subjects 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).
OG002	Pooled Placebo

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)

ID	Title	Description
OG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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).
OG001	Ciprofloxacin DPI 14 Days on/Off (Cipro 14)	Subjects 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).

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)

ID	Title	Description
OG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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).
OG001	Ciprofloxacin DPI 14 Days on/Off (Cipro 14)	Subjects 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).
OG002	Pooled Placebo	Subjects 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).

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)

ID	Title	Description
OG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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).
OG001	Ciprofloxacin DPI 14 Days on/Off (Cipro 14)	Subjects 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).

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)

ID	Title	Description
OG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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).
OG001	Ciprofloxacin DPI 14 Days on/Off (Cipro 14)	Subjects 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).
OG002	Placebo 28 Days on/Off (Placebo 28)

Primary

Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo

Full analysis set (FAS) included participants who were randomized.

Posted

Median

95.1% Confidence Interval

Days

Up to Week 48

ID	Title	Description
OG000	Ciprofloxacin DPI 14 Days on/Off (Cipro 14)	Subjects 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).
OG001	Pooled Placebo	Subjects 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).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Atrial flutter	Cardiac disorders	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Cor pulmonale	Cardiac disorders	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Vitreous detachment	Eye disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Colitis	Gastrointestinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0002 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Chronic sinusitis	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Diverticulitis	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Herpes zoster	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Pneumonia	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0004 events3 affected171 at risk EG0012 events2 affected174 at risk EG0022 events2 affected174 at risk
Pneumonia viral	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Sepsis	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Bronchitis bacterial	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0013 events3 affected174 at risk EG0024 events2 affected174 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0021 events1 affected174 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Glottis carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (19.0)	Non-systematic Assessment	EG0001 events1 affected171 at risk EG0010 events0 affected174 at risk EG0020 events0 affected174 at risk
Suicide attempt	Psychiatric disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG00020 events17 affected171 at risk EG00127 events24 affected174 at risk EG00231 events21 affected174 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0016 events3 affected174 at risk EG0021 events1 affected174 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0003 events2 affected171 at risk EG0013 events3 affected174 at risk EG0024 events4 affected174 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0011 events1 affected174 at risk EG0020 events0 affected174 at risk
Hypertensive crisis	Vascular disorders	MedDRA (19.0)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected174 at risk EG0021 events1 affected174 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Peoria	Arizona	85381	United States

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D015656	Respiratory Mechanics
D012119	Respiration
D012143	Respiratory Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena

ID	Title	Description
BG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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)	Subjects 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)	Subjects 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)	Subjects 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

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ciprofloxacin DPI 28 Days on/Off (Cipro 28)	Subjects 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).	28	171	51	171
EG001	Ciprofloxacin DPI 14 Days on/Off (Cipro 14)	Subjects 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).	45	174	60	174
EG002	Pooled Placebo	Subjects 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).	41	174	55	174

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG00011 events10 affected171 at risk EG00119 events16 affected174 at risk EG00218 events14 affected174 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.0)	Non-systematic Assessment	EG00013 events10 affected171 at risk EG00110 events8 affected174 at risk EG0026 events5 affected174 at risk
Dysgeusia	Nervous system disorders	MedDRA (19.0)	Non-systematic Assessment	EG00013 events9 affected171 at risk EG00116 events8 affected174 at risk EG0022 events2 affected174 at risk
Headache	Nervous system disorders	MedDRA (19.0)	Non-systematic Assessment	EG00015 events10 affected171 at risk EG00111 events10 affected174 at risk EG0025 events5 affected174 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0003 events3 affected171 at risk EG0017 events7 affected174 at risk EG0029 events9 affected174 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0009 events5 affected171 at risk EG0017 events7 affected174 at risk EG00212 events11 affected174 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG0005 events4 affected171 at risk EG00111 events10 affected174 at risk EG0026 events3 affected174 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.0)	Non-systematic Assessment	EG00019 events11 affected171 at risk EG00122 events15 affected174 at risk EG00241 events20 affected174 at risk