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Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00930982
First received: June 30, 2009
Last updated: April 14, 2013
Last verified: April 2013
History of Changes
Results First Received: September 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bronchiectasis
Interventions: Drug: Ciprofloxacin (Cipro, BAYQ3939)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pulmonary stable participants with a proven and documented diagnosis of non-cystic fibrosis bronchiectasis (idiopathic or postpneumonic), and on a stable regimen of standard treatment, were recruited at specialized study sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 277 participants screened, 153 failed screening (mostly due to not meeting in-/exclusion criteria or inability to produce adequate sputum samples), and 124 participants were randomized (60 to Ciprofloxacin Inhale and 64 to placebo).

Reporting Groups
  Description
Ciprofloxacin Inhale (BAYQ3939) 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Placebo Inhalation of matching placebo twice a day

Participant Flow:   Overall Study
    Ciprofloxacin Inhale (BAYQ3939)     Placebo  
STARTED     60     64  
COMPLETED     39     35  
NOT COMPLETED     21     29  
Adverse Event                 19                 23  
Protocol Violation                 1                 5  
Withdrawal by Subject                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Ciprofloxacin Inhale (BAYQ3939) 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
Placebo Inhalation of matching placebo twice a day
Total Total of all reporting groups

Baseline Measures
    Ciprofloxacin Inhale (BAYQ3939)     Placebo     Total  
Number of Participants  
[units: participants]
 		  60     64     124  
Age  
[units: Years]
Mean ± Standard Deviation 		  64.7  ± 11.8     61.4  ± 11.9     63.0  ± 11.9  
Gender  
[units: Participants]
 		     
Female     39     43     82  
Male     21     21     42  



  Outcome Measures
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1.  Primary:   Change From Baseline in Total Bacterial Load in the Sputum at End of Treatment (Day 29).   [ Time Frame: Baseline and 29 days ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Baseline and up to end of study (planned at Day 84) ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Forced Vital Capacity (FVC)   [ Time Frame: Baseline and up to end of study (planned at Day 84) ]
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4.  Secondary:   Time to Exacerbation With Antibiotic Intervention   [ Time Frame: Up to end of study (planned at Day 84) ]
  Show Outcome Measure 4

5.  Secondary:   Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by the Saint George's Respiratory Questionnaire (SGRQ), Total Score   [ Time Frame: Up to end of study (planned at Day 84) ]
  Show Outcome Measure 5

6.  Secondary:   Effect of Ciprofloxacin Inhale Treatment on Health-related Quality of Life (HRQoL) as Measured by Chronic Respiratory Questionnaire – Self Administered Standardized (CRQ-SAS)   [ Time Frame: Up to end of study (planned at Day 84) ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in High Sensitive C-reactive Protein (hsCRP)   [ Time Frame: Baseline and up to Day 42 ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Absolute Neutrophil Count (ANC)   [ Time Frame: Baseline and up to Day 42 ]
  Show Outcome Measure 8

9.  Secondary:   24-hour Sputum Volume   [ Time Frame: Up to end of study (planned at Day 84) ]
  Show Outcome Measure 9

10.  Secondary:   24-hour Sputum Color (Percentage of Participants With Non-clear Sputum)   [ Time Frame: Up to end of study (planned at Day 84) ]
  Show Outcome Measure 10

11.  Secondary:   Microbiological Response of Cipro Inhale Per Participant   [ Time Frame: Up to end of study (planned at Day 84) ]
  Show Outcome Measure 11

12.  Secondary:   Microbiological Response of Cipro Inhale Per Pathogen   [ Time Frame: Up to end of study (planned at Day 84) ]
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13.  Secondary:   Emergence of New Potential Respiratory Pathogens   [ Time Frame: Up to end of study (planned at Day 84) ]
  Show Outcome Measure 13

14.  Secondary:   Emergence of Resistance Among Baseline Pathogens   [ Time Frame: Up to end of study (planned at Day 84) ]
  Show Outcome Measure 14

15.  Other Pre-specified:   Change From Baseline in Total Bacterial Load in the Sputum   [ Time Frame: Baseline and up to end of study (planned at Day 84) ]
  Show Outcome Measure 15


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:


Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00930982     History of Changes
Other Study ID Numbers: 12965, 2009-009869-34
Study First Received: June 30, 2009
Results First Received: September 19, 2011
Last Updated: April 14, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
UK: Medicines and Healthcare products Regulatory Agency_MHRA0
Australia: Department of Health and Ageing, TGA/ Therapeutic Goods Administration
Sweden: Medical Products Agency