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

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ClinicalTrials.gov Identifier: NCT01764841
Recruitment Status : Completed
First Posted : January 10, 2013
Results First Posted : May 24, 2017
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Ciprofloxacin DPI (BAYQ3939) Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 2, 2013
Actual Primary Completion Date : March 9, 2016
Actual Study Completion Date : March 9, 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764841


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Locations
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United States, Alabama
Jasper, Alabama, United States, 35501
United States, Arizona
Flagstaff, Arizona, United States, 86001
Phoenix, Arizona, United States, 85006-2611
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Fort Smith, Arkansas, United States, 72901
United States, California
Los Angeles, California, United States, 90048
Torrance, California, United States
Ventura, California, United States, 93003
United States, Connecticut
Farmington, Connecticut, United States, 06030
Waterbury, Connecticut, United States, 06708-2513
United States, District of Columbia
Washington, District of Columbia, United States, 20007-2197
United States, 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
United States, Georgia
Lawrenceville, Georgia, United States, 30046
Marietta, Georgia, United States, 30060
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Indiana
Michigan City, Indiana, United States, 46360
United States, Kentucky
Hazard, Kentucky, United States, 41701
United States, Missouri
Chesterfield, Missouri, United States, 63017
United States, New Jersey
Summit, New Jersey, United States, 07901
United States, New York
New Hyde Park, New York, United States, 11042
New York, New York, United States, 10016
United States, Oregon
Portland, Oregon, United States, 97239-3011
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, 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
United States, Virginia
Abingdon, Virginia, United States, 24210
Richmond, Virginia, United States, 23225
United States, Washington
Spokane, Washington, United States, 99202-1334
Tacoma, Washington, United States, 98405
Argentina
Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425DES
Godoy Cruz, Mendoza, Argentina, 5501
Vicente López, Argentina, 1638
Australia, Queensland
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Adelaide, South Australia, Australia, 5041
Woodville, South Australia, Australia, 5011
Australia, Victoria
Parkville, Victoria, Australia, 3050
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Murdoch, Western Australia, Australia, 6150
Australia
Box Hill, Australia, 3128
Cairns, Australia, 4870
Frankston, Australia, 3199
Kogarah, Australia, 2217
Toorak Gardens, Australia, 5065
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
Heidelberg, Baden-Württemberg, Germany, 69126
Cottbus, Brandenburg, Germany, 03050
Frankfurt, Hessen, Germany, 60389
Neu-Isenburg, Hessen, Germany, 63263
Hannover, Niedersachsen, Germany, 30173
Hannover, Niedersachsen, Germany, 30625
Koblenz, Rheinland-Pfalz, Germany, 56068
Geesthacht, Schleswig-Holstein, Germany, 21502
Jena, Thüringen, Germany, 07740
Berlin, Germany, 10717
Berlin, Germany, 10969
Berlin, Germany, 12203
Hamburg, Germany, 22767
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
Benevento, Campania, Italy, 82037
Trieste, Friuli-Venezia Giulia, Italy, 34149
Roma, Lazio, Italy, 00168
Pavia, Lombardia, Italy, 27040
Varese, Lombardia, Italy, 21049
Bari, Puglia, Italy, 70020
Cagliari, Sardegna, Italy, 09126
Catania, Sicilia, Italy, 95123
Pisa, Toscana, Italy, 56124
Verona, Veneto, Italy, 37126
Japan
Toon, Ehime, Japan, 791-0281
Nakagun, Ibaraki, Japan, 319-1113
Koshi, Kumamoto, Japan, 861-1196
Matsusaka, Mie, Japan, 515-8544
Tsu, Mie, Japan, 514-1101
Sakai, Osaka, Japan, 591-8555
Hamamatsu, Shizuoka, Japan, 434-8511
Kiyose, Tokyo, Japan, 204-8585
Mitaka, Tokyo, Japan, 181-8611
Fukuoka, Japan, 811-1394
Latvia
Daugavpils, Latvia, LV-5403
Daugavpils, Latvia, LV-5410
Jurmala, Latvia, LV-2010
Kraslava, Latvia, 5601
Riga, Latvia, LV-1001
Riga, Latvia, LV-1002
Riga, Latvia, LV-1011
Riga, Latvia, LV-1038
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
Santiago de Compostela, A Coruña, Spain, 15706
Elda, Alicante, Spain, 03600
Oviedo, Asturias, Spain, 33006
Badalona, Barcelona, Spain, 08916
L'Hospitalet, Barcelona, Spain, 08907
Sant Boi de Llobregat, Barcelona, Spain, 08830
Terrassa, Barcelona, Spain, 08221
Pozuelo de Alarcón, Madrid, Spain, 28223
Barcelona, Spain, 08036
Barcelona, Spain, 08041
Cáceres, Spain, 10003
Madrid, Spain, 28006
Madrid, Spain, 28034
Madrid, Spain, 28040
Pontevedra, Spain, 36071
Valencia, Spain, 46017
Valencia, Spain, 46026
United Kingdom
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Exeter, Devon, United Kingdom, EX2 5DW
Plymouth, Devon, United Kingdom, PL6 8DH
Torbay, Devon, United Kingdom, TQ2 7AA
Dundee, Dundee City, United Kingdom, DD1 9SY
Belfast, North Ireland, United Kingdom, BT12 7AB
Shrewsbury, Shropshire, United Kingdom, SY3 8XQ
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Londonderry, United Kingdom, BT47 6SB
London, United Kingdom, SW3 6NP
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Bayer
Novartis
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01764841     History of Changes
Other Study ID Numbers: 15625
2011-004208-39 ( EudraCT Number )
First Posted: January 10, 2013    Key Record Dates
Results First Posted: May 24, 2017
Last Update Posted: January 24, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Ciprofloxacin
Dry Powder for Inhalation
Exacerbation
Bronchiectasis
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors