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Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) (RESPIRE 1)

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ciprofloxacin DPI (BAYQ3939)
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 Cystic Fibrosis (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

Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).

Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).

Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).

Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).

Outcomes

Primary Outcome Measures

Time to First Exacerbation Event Within 48 Weeks
Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.

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
January 8, 2013
Last Updated
January 3, 2018
Sponsor
Bayer
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01764841
Brief Title
Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Acronym
RESPIRE 1
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
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2013 (Actual)
Primary Completion Date
March 9, 2016 (Actual)
Study Completion Date
March 9, 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
Yes

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. The statistical analysis tests for the efficacy variables will be performed hierarchically. The comparisons ciprofloxacin DPI vs. pooled placebo (according to statistical analysis plan defined for FDA registration) will be performed in parallel for the regimen 28 days on/off and 14 days on/off.

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
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ciprofloxacin DPI 28 Days on/off (Cipro 28)
Arm Type
Experimental
Arm Description
Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
Arm Title
Ciprofloxacin DPI 14 Days on/off (Cipro 14)
Arm Type
Experimental
Arm Description
Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
Arm Title
Placebo 28 Days on/off (Placebo 28)
Arm Type
Placebo Comparator
Arm Description
Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
Arm Title
Placebo 14 Days on/off (Placebo 14)
Arm Type
Placebo Comparator
Arm Description
Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin DPI (BAYQ3939)
Intervention Description
Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.
Primary Outcome Measure Information:
Title
Time to First Exacerbation Event Within 48 Weeks
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 Cystic Fibrosis (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
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2611
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Torrance
State/Province
California
Country
United States
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708-2513
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2197
Country
United States
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3011
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708-3154
Country
United States
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202-1334
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Buenos Aires
State/Province
Ciudad Auton. De Buenos Aires
ZIP/Postal Code
C1425DES
Country
Argentina
City
Godoy Cruz
State/Province
Mendoza
ZIP/Postal Code
5501
Country
Argentina
City
Vicente López
ZIP/Postal Code
1638
Country
Argentina
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
City
Cairns
ZIP/Postal Code
4870
Country
Australia
City
Frankston
ZIP/Postal Code
3199
Country
Australia
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
City
Toorak Gardens
ZIP/Postal Code
5065
Country
Australia
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
City
Montpellier
ZIP/Postal Code
34059
Country
France
City
Nimes
ZIP/Postal Code
30900
Country
France
City
Toulon
ZIP/Postal Code
83000
Country
France
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69126
Country
Germany
City
Cottbus
State/Province
Brandenburg
ZIP/Postal Code
03050
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
Koblenz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
56068
Country
Germany
City
Geesthacht
State/Province
Schleswig-Holstein
ZIP/Postal Code
21502
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
10969
Country
Germany
City
Berlin
ZIP/Postal Code
12203
Country
Germany
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
City
Afula
ZIP/Postal Code
1834111
Country
Israel
City
Ashkelon
ZIP/Postal Code
7827804
Country
Israel
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Benevento
State/Province
Campania
ZIP/Postal Code
82037
Country
Italy
City
Trieste
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
34149
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27040
Country
Italy
City
Varese
State/Province
Lombardia
ZIP/Postal Code
21049
Country
Italy
City
Bari
State/Province
Puglia
ZIP/Postal Code
70020
Country
Italy
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09126
Country
Italy
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0281
Country
Japan
City
Nakagun
State/Province
Ibaraki
ZIP/Postal Code
319-1113
Country
Japan
City
Koshi
State/Province
Kumamoto
ZIP/Postal Code
861-1196
Country
Japan
City
Matsusaka
State/Province
Mie
ZIP/Postal Code
515-8544
Country
Japan
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-1101
Country
Japan
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
434-8511
Country
Japan
City
Kiyose
State/Province
Tokyo
ZIP/Postal Code
204-8585
Country
Japan
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
City
Fukuoka
ZIP/Postal Code
811-1394
Country
Japan
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
Talsu
ZIP/Postal Code
3201
Country
Latvia
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
City
Auckland
ZIP/Postal Code
1640
Country
New Zealand
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
City
Dunedin
Country
New Zealand
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
City
Bratislava
ZIP/Postal Code
821 06
Country
Slovakia
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
City
Elda
State/Province
Alicante
ZIP/Postal Code
03600
Country
Spain
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
L'Hospitalet
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Sant Boi de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08830
Country
Spain
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Torbay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
City
Dundee
State/Province
Dundee City
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
City
Belfast
State/Province
North Ireland
ZIP/Postal Code
BT12 7AB
Country
United Kingdom
City
Shrewsbury
State/Province
Shropshire
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Londonderry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29371383
Citation
De Soyza A, Aksamit T, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702052. doi: 10.1183/13993003.02052-2017. Print 2018 Jan.
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 in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)

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