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

January 3, 2018 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

416

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Vicente López, Argentina, 1638
    • Ciudad Auton. De Buenos Aires
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425DES
    • Mendoza
      • Godoy Cruz, Mendoza, Argentina, 5501
  • Australia
      • Box Hill, Australia, 3128
      • Cairns, Australia, 4870
      • Frankston, Australia, 3199
      • Kogarah, Australia, 2217
      • Toorak Gardens, Australia, 5065
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
    • South Australia
      • Adelaide, South Australia, Australia, 5000
      • Adelaide, South Australia, Australia, 5041
      • Woodville, South Australia, Australia, 5011
    • Victoria
      • Parkville, Victoria, Australia, 3050
      • Prahran, Victoria, Australia, 3181
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
  • Denmark
      • Aarhus C, Denmark, 8000
      • Hellerup, Denmark, 2900
      • Naestved, Denmark, 4700
      • Roskilde, Denmark, 4000
  • France
      • Clermont Ferrand, France, 63000
      • Montpellier, France, 34059
      • Nimes, France, 30900
      • Toulon, France, 83000
  • Germany
      • Berlin, Germany, 10969
      • Berlin, Germany, 12203
      • Berlin, Germany, 10717
      • Hamburg, Germany, 22767
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69126
    • Brandenburg
      • Cottbus, Brandenburg, Germany, 03050
    • Hessen
      • Frankfurt, Hessen, Germany, 60389
      • Neu-Isenburg, Hessen, Germany, 63263
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
      • Hannover, Niedersachsen, Germany, 30173
    • Rheinland-Pfalz
      • Koblenz, Rheinland-Pfalz, Germany, 56068
    • Schleswig-Holstein
      • Geesthacht, Schleswig-Holstein, Germany, 21502
    • Thüringen
      • Jena, Thüringen, Germany, 07740
  • Israel
      • Afula, Israel, 1834111
      • Ashkelon, Israel, 7827804
      • Beer Sheva, Israel, 8410101
      • Haifa, Israel, 3109601
      • Haifa, Israel, 3436212
      • Jerusalem, Israel, 9112001
      • Petah Tikva, Israel, 4941492
      • Ramat Gan, Israel, 5262000
      • Rehovot, Israel, 7610001
      • Tel Aviv, Israel, 6423906
  • Italy
    • Campania
      • Benevento, Campania, Italy, 82037
    • Friuli-Venezia Giulia
      • Trieste, Friuli-Venezia Giulia, Italy, 34149
    • Lazio
      • Roma, Lazio, Italy, 00168
    • Lombardia
      • Pavia, Lombardia, Italy, 27040
      • Varese, Lombardia, Italy, 21049
    • Puglia
      • Bari, Puglia, Italy, 70020
    • Sardegna
      • Cagliari, Sardegna, Italy, 09126
    • Sicilia
      • Catania, Sicilia, Italy, 95123
    • Toscana
      • Pisa, Toscana, Italy, 56124
    • Veneto
      • Verona, Veneto, Italy, 37126
  • Japan
      • Fukuoka, Japan, 811-1394
    • Ehime
      • Toon, Ehime, Japan, 791-0281
    • Ibaraki
      • Nakagun, Ibaraki, Japan, 319-1113
    • Kumamoto
      • Koshi, Kumamoto, Japan, 861-1196
    • Mie
      • Matsusaka, Mie, Japan, 515-8544
      • Tsu, Mie, Japan, 514-1101
    • Osaka
      • Sakai, Osaka, Japan, 591-8555
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 434-8511
    • Tokyo
      • Kiyose, Tokyo, Japan, 204-8585
      • Mitaka, Tokyo, Japan, 181-8611
  • Latvia
      • Daugavpils, Latvia, LV-5403
      • Daugavpils, Latvia, LV-5410
      • Jurmala, Latvia, LV-2010
      • Kraslava, Latvia, 5601
      • Riga, Latvia, LV-1002
      • Riga, Latvia, LV-1038
      • Riga, Latvia, LV-1001
      • Riga, Latvia, LV-1011
      • Talsu, Latvia, 3201
  • New Zealand
      • Auckland, New Zealand, 1051
      • Auckland, New Zealand, 1640
      • Christchurch, New Zealand, 8011
      • Dunedin, New Zealand
      • Hamilton, New Zealand, 3240
      • Tauranga, New Zealand, 3110
      • Wellington, New Zealand, 6021
  • Slovakia
      • Bratislava, Slovakia, 821 06
      • Presov, Slovakia, 080 01
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08041
      • Cáceres, Spain, 10003
      • Madrid, Spain, 28006
      • Madrid, Spain, 28040
      • Madrid, Spain, 28034
      • Pontevedra, Spain, 36071
      • Valencia, Spain, 46017
      • Valencia, Spain, 46026
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
    • Alicante
      • Elda, Alicante, Spain, 03600
    • Asturias
      • Oviedo, Asturias, Spain, 33006
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
      • L'Hospitalet, Barcelona, Spain, 08907
      • Sant Boi de Llobregat, Barcelona, Spain, 08830
      • Terrassa, Barcelona, Spain, 08221
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
  • United Kingdom
      • London, United Kingdom, SW3 6NP
      • Londonderry, United Kingdom, BT47 6SB
      • Manchester, United Kingdom, M23 9LT
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
      • Plymouth, Devon, United Kingdom, PL6 8DH
      • Torbay, Devon, United Kingdom, TQ2 7AA
    • Dundee City
      • Dundee, Dundee City, United Kingdom, DD1 9SY
    • North Ireland
      • Belfast, North Ireland, United Kingdom, BT12 7AB
    • Shropshire
      • Shrewsbury, Shropshire, United Kingdom, SY3 8XQ
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
  • United States
    • Alabama
      • Jasper, Alabama, United States, 35501
    • Arizona
      • Flagstaff, Arizona, United States, 86001
      • Phoenix, Arizona, United States, 85006-2611
      • Scottsdale, Arizona, United States, 85258
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
    • California
      • Los Angeles, California, United States, 90048
      • Torrance, California, United States
      • Ventura, California, United States, 93003
    • Connecticut
      • Farmington, Connecticut, United States, 06030
      • Waterbury, Connecticut, United States, 06708-2513
    • District of Columbia
      • Washington, District of Columbia, United States, 20007-2197
    • Florida
      • Celebration, Florida, United States, 34747
      • Miami, Florida, United States, 33136
      • Orlando, Florida, United States, 32803
      • Weston, Florida, United States, 33331
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
      • Marietta, Georgia, United States, 30060
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Indiana
      • Michigan City, Indiana, United States, 46360
    • Kentucky
      • Hazard, Kentucky, United States, 41701
    • Missouri
      • Chesterfield, Missouri, United States, 63017
    • New Jersey
      • Summit, New Jersey, United States, 07901
    • New York
      • New Hyde Park, New York, United States, 11042
      • New York, New York, United States, 10016
    • Oregon
      • Portland, Oregon, United States, 97239-3011
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19140
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Texas
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77043
      • Kingwood, Texas, United States, 77339
      • McKinney, Texas, United States, 75069
      • Tyler, Texas, United States, 75708-3154
    • Virginia
      • Abingdon, Virginia, United States, 24210
      • Richmond, Virginia, United States, 23225
    • Washington
      • Spokane, Washington, United States, 99202-1334
      • Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ciprofloxacin DPI 28 Days on/off (Cipro 28)
Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
Drug: Ciprofloxacin DPI (BAYQ3939)
Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.
EXPERIMENTAL: Ciprofloxacin DPI 14 Days on/off (Cipro 14)
Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
Drug: Ciprofloxacin DPI (BAYQ3939)
Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.
PLACEBO_COMPARATOR: Placebo 28 Days on/off (Placebo 28)
Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
Drug: Placebo
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.
PLACEBO_COMPARATOR: Placebo 14 Days on/off (Placebo 14)
Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Exacerbation Event Within 48 Weeks
Time Frame: Up to Week 48
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
Time Frame: Up to Week 48
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
Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
Time Frame: Up to Week 48
For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.
Up to Week 48
Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
Time Frame: End of treatment (Week 44/46)
Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.
End of treatment (Week 44/46)
Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)
Time Frame: Baseline and end of treatment (Week 44/46)
The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.
Baseline and end of treatment (Week 44/46)
Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
Time Frame: End of treatment (Week 44/46)
New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.
End of treatment (Week 44/46)
Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)
Time Frame: Baseline and end of treatment (Week 44/46)
The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.
Baseline and end of treatment (Week 44/46)
Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)
Time Frame: Baseline and end of treatment (Week 44/46)
FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).
Baseline and end of treatment (Week 44/46)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2013

Primary Completion (ACTUAL)

March 9, 2016

Study Completion (ACTUAL)

March 9, 2016

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (ESTIMATE)

January 10, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 3, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15625
  • 2011-004208-39 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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