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Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) (RESPIRE 2)

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ciprofloxacin (BAYQ3939) dry powder for inhalation
Ciprofloxacin (BAYQ3939) dry powder for inhalation
Placebo
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Ciprofloxacin, Dry Powder for Inhalation, Exacerbation, Bronchiectasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a proven and documented diagnosis of non CF idiopathic or post infectious bronchiectasis
  • Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks

Exclusion Criteria:

  • Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted
  • Active allergic bronchopulmonary aspergillosis
  • Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis
  • Primary diagnosis of Chronic obstructive pulmonary disease (COPD)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Ciprofloxacin DPI 28 Days on/off (Cipro 28)

Ciprofloxacin DPI 14 Days on/off (Cipro 14)

Placebo 28 Days on/off (Placebo 28)

Placebo 14 Days on/off (Placebo 14)

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
April 4, 2014
Last Updated
September 4, 2017
Sponsor
Bayer
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02106832
Brief Title
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Acronym
RESPIRE 2
Official Title
Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 30, 2014 (Actual)
Primary Completion Date
September 13, 2016 (Actual)
Study Completion Date
October 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Novartis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Number of participants with Adverse events will be covered in Adverse Events section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Ciprofloxacin, Dry Powder for Inhalation, Exacerbation, Bronchiectasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ciprofloxacin DPI 28 Days on/off (Cipro 28)
Arm Type
Experimental
Arm Description
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).
Arm Title
Ciprofloxacin DPI 14 Days on/off (Cipro 14)
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo 28 Days on/off (Placebo 28)
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Placebo 14 Days on/off (Placebo 14)
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin (BAYQ3939) dry powder for inhalation
Intervention Description
Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin (BAYQ3939) dry powder for inhalation
Intervention Description
Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off
Primary Outcome Measure Information:
Title
Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo
Description
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.
Time Frame
Up to Week 48
Title
Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo
Description
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.
Time Frame
Up to Week 48
Secondary Outcome Measure Information:
Title
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Description
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.
Time Frame
Up to Week 48
Title
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Description
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.
Time Frame
Up to Week 48
Title
Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
Description
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.
Time Frame
End of treatment (Week 44/46)
Title
Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)
Description
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.
Time Frame
Baseline and end of treatment (Week 44/46)
Title
Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
Description
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.
Time Frame
End of treatment (Week 44/46)
Title
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)
Description
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.
Time Frame
Baseline and end of treatment (Week 44/46)
Title
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)
Description
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).
Time Frame
Baseline and end of treatment (Week 44/46)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a proven and documented diagnosis of non CF idiopathic or post infectious bronchiectasis Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks Exclusion Criteria: Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted Active allergic bronchopulmonary aspergillosis Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis Primary diagnosis of Chronic obstructive pulmonary disease (COPD)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
90708
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708-3154
Country
United States
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1425DES
Country
Argentina
City
Capital Federal
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
City
Godoy Cruz
State/Province
Mendoza
ZIP/Postal Code
5501
Country
Argentina
City
Córdoba
ZIP/Postal Code
X5003DCE
Country
Argentina
City
Vicente López
ZIP/Postal Code
1638
Country
Argentina
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50920640
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90610-000
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90880-480
Country
Brazil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90035-074
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01244-030
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
City
Razgrad
ZIP/Postal Code
7200
Country
Bulgaria
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
City
Hohehot
State/Province
Inner Mongolia
ZIP/Postal Code
010050
Country
China
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
City
Beijing
ZIP/Postal Code
100029
Country
China
City
Beijing
ZIP/Postal Code
100144
Country
China
City
Chongqing
ZIP/Postal Code
400042
Country
China
City
Shanghai
ZIP/Postal Code
200032
Country
China
City
Shanghai
ZIP/Postal Code
200040
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
City
Prague 4
ZIP/Postal Code
140 46
Country
Czechia
City
Praha 2
ZIP/Postal Code
121 11
Country
Czechia
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
City
Treuenbrietzen
State/Province
Brandenburg
ZIP/Postal Code
14929
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60389
Country
Germany
City
Neu-Isenburg
State/Province
Hessen
ZIP/Postal Code
63263
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30173
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Gelsenkirchen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45879
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04357
Country
Germany
City
Bad Berka
State/Province
Thüringen
ZIP/Postal Code
99437
Country
Germany
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07740
Country
Germany
City
Berlin
ZIP/Postal Code
10717
Country
Germany
City
Berlin
ZIP/Postal Code
14059
Country
Germany
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
City
Hong Kong
Country
Hong Kong
City
Kowloon
Country
Hong Kong
City
New Territories
Country
Hong Kong
City
Shatin
Country
Hong Kong
City
Daejeon
State/Province
Daejeon Gwang''yeogsi
ZIP/Postal Code
301-723
Country
Korea, Republic of
City
Bucheon
State/Province
Gyeonggido
ZIP/Postal Code
420-717
Country
Korea, Republic of
City
Incheon Gwangyeogsi,
State/Province
Incheon Gwang''yeogsi
ZIP/Postal Code
403-720
Country
Korea, Republic of
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
135-720
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
100-032
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
City
Daugavpils
ZIP/Postal Code
LV-5403
Country
Latvia
City
Daugavpils
ZIP/Postal Code
LV-5410
Country
Latvia
City
Jurmala
ZIP/Postal Code
LV-2010
Country
Latvia
City
Kraslava
ZIP/Postal Code
5601
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1011
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1038
Country
Latvia
City
Talsi
ZIP/Postal Code
LV-3201
Country
Latvia
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
City
Assen
ZIP/Postal Code
9403 RK
Country
Netherlands
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
City
Veldhoven
ZIP/Postal Code
5500 MB
Country
Netherlands
City
City of San Fernando
ZIP/Postal Code
2000
Country
Philippines
City
Manila
ZIP/Postal Code
1000
Country
Philippines
City
Manila
ZIP/Postal Code
1012
Country
Philippines
City
Quezon City
ZIP/Postal Code
NCR 1100
Country
Philippines
City
Quezon City
ZIP/Postal Code
NCR 1104
Country
Philippines
City
Bielsko-Biala
ZIP/Postal Code
43-300
Country
Poland
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
City
Gorzow Wielkopolski
ZIP/Postal Code
66-400
Country
Poland
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
City
Katowice
ZIP/Postal Code
40-954
Country
Poland
City
Kielce
ZIP/Postal Code
25-035
Country
Poland
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
City
Kielce
ZIP/Postal Code
25-751
Country
Poland
City
Krakow
ZIP/Postal Code
31-455
Country
Poland
City
Ksawerow
ZIP/Postal Code
95-054
Country
Poland
City
Mrozy
ZIP/Postal Code
05-320
Country
Poland
City
Ostrowiec Swietokrzyski
ZIP/Postal Code
27-400
Country
Poland
City
Rzeszow
ZIP/Postal Code
35-301
Country
Poland
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
City
Vila Nova de Gaia
State/Province
Porto
ZIP/Postal Code
4434-502
Country
Portugal
City
Angra do Heroísmo
State/Province
Região Autónoma dos Açores
ZIP/Postal Code
9701-856
Country
Portugal
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
City
Bragadiru
ZIP/Postal Code
077025
Country
Romania
City
Brasov
ZIP/Postal Code
500086
Country
Romania
City
Bucharest
ZIP/Postal Code
010457
Country
Romania
City
Bucharest
ZIP/Postal Code
011461
Country
Romania
City
Bucharest
ZIP/Postal Code
030303
Country
Romania
City
Bucharest
ZIP/Postal Code
050159
Country
Romania
City
Codlea
ZIP/Postal Code
505100
Country
Romania
City
Constanta
ZIP/Postal Code
900002
Country
Romania
City
Iasi
ZIP/Postal Code
700141
Country
Romania
City
Ploiesti
ZIP/Postal Code
100184
Country
Romania
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
City
Arkhangelsk
ZIP/Postal Code
163001
Country
Russian Federation
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603035
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630075
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194295
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
City
Tomsk
ZIP/Postal Code
634063
Country
Russian Federation
City
Ufa
ZIP/Postal Code
450071
Country
Russian Federation
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
City
Cacak
ZIP/Postal Code
32000
Country
Serbia
City
Knez Selo
ZIP/Postal Code
18204
Country
Serbia
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
City
Sombor
ZIP/Postal Code
25000
Country
Serbia
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
City
Valjevo
ZIP/Postal Code
14000
Country
Serbia
City
Bratislava
ZIP/Postal Code
821 06
Country
Slovakia
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2092
Country
South Africa
City
Amanzimtoti
State/Province
Kwazulu-Natal
ZIP/Postal Code
4127
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7764
Country
South Africa
City
Chiayi
ZIP/Postal Code
613
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
City
New Taipei City,
ZIP/Postal Code
23561
Country
Taiwan
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Chiangmai
ZIP/Postal Code
50200
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
City
NakhonRatchasima
ZIP/Postal Code
30000
Country
Thailand
City
Phitsanulok
ZIP/Postal Code
65000
Country
Thailand
City
Udonthani
ZIP/Postal Code
41000
Country
Thailand
City
Ankara
ZIP/Postal Code
061100
Country
Turkey
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
City
Balcali
ZIP/Postal Code
01330
Country
Turkey
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
City
Kampus
ZIP/Postal Code
07058
Country
Turkey
City
Konya
ZIP/Postal Code
42080
Country
Turkey
City
Maltepe
ZIP/Postal Code
34844
Country
Turkey
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
City
Pendik
ZIP/Postal Code
34890
Country
Turkey
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
City
Sehitkamil
ZIP/Postal Code
27310
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
29371384
Citation
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.
Results Reference
derived
PubMed Identifier
28495619
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)

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