Trial record 17 of 34 for:
Open Studies | "Bronchiectasis"
Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) (RESPIRE 1)
This study is not yet open for participant recruitment.
Verified January 2013 by Bayer
Sponsor:
Bayer
Collaborator:
Novartis
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01764841
First received: January 8, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Bronchiectasis |
Drug: Ciprofloxacin DPI (BAYQ3939) Drug: Placebo |
Phase 3 |
| 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 |
| 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. |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Time to first exacerbation [ Time Frame: over 48 weeks after baseline ] [ Designated as safety issue: No ]Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics
Secondary Outcome Measures:
- Mean number of exacerbations per patient per 48 weeks [ Time Frame: over 48 weeks after baseline ] [ Designated as safety issue: No ]Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics
- Pathogens present at baseline and eradicated at 48 weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
- Changes of Saint George's Respiratory Questionnaire score from baseline to 48 weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
- New pathogens at 48 weeks, not present at baseline [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
- Changes of Forced expiratory volume in 1 second from baseline to 48 weeks [ Time Frame: over 56 weeks after screening ] [ Designated as safety issue: No ]
- Number of participants with Adverse events as a measure of safety and tolerability [ Time Frame: over 56 weeks after screening ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ciprofloxacin DPI 28 days cycle
Inhalation of 32.5 mg Ciprofloxacin DPI inhaled twice a day intermittently administered for 28 days on / 28 days off
|
Drug: Ciprofloxacin DPI (BAYQ3939) |
|
Placebo Comparator: Placebo 28 days cycle
Inhalation of Placebo inhaled twice a day intermittently administered for 28 days on / 28 days off
|
Drug: Placebo |
|
Experimental: Ciprofloxacin DPI 14 days cycle
Inhalation of 32.5 mg Ciprofloxacin DPI inhaled twice a day intermittently administered for 14 days on / 14 days off
|
Drug: Ciprofloxacin DPI (BAYQ3939) |
|
Placebo Comparator: Placebo 14 days cycle
Inhalation of Placebo inhaled twice a day intermittently administered for 14 days on / 14 days off
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764841
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Locations
| Australia, South Australia | |
| Not yet recruiting | |
| Adelaide, South Australia, Australia, 5041 | |
| Italy | |
| Not yet recruiting | |
| Cassano Murge, Bari, Italy, 70020 | |
| Not yet recruiting | |
| Telese Terme, Benevento, Italy, 82037 | |
| Not yet recruiting | |
| Montescano, Pavia, Italy, 27040 | |
| Not yet recruiting | |
| Tradate, Varese, Italy, 21049 | |
| Not yet recruiting | |
| Cagliari, Italy, 09126 | |
| Not yet recruiting | |
| Pisa, Italy, 56124 | |
| United Kingdom | |
| Not yet recruiting | |
| Exeter, Devon, United Kingdom, EX2 5DW | |
| Not yet recruiting | |
| Plymouth, Devon, United Kingdom, PL6 8DH | |
| Not yet recruiting | |
| Torbay, Devon, United Kingdom, TQ2 7AA | |
| Not yet recruiting | |
| Belfast, North Ireland, United Kingdom, BT12 7AB | |
| Not yet recruiting | |
| Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN | |
| Not yet recruiting | |
| London, United Kingdom, SW3 6NP | |
| Not yet recruiting | |
| Manchester, United Kingdom, M23 9LT | |
Sponsors and Collaborators
Bayer
Novartis
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01764841 History of Changes |
| Other Study ID Numbers: | 15625 |
| Study First Received: | January 8, 2013 |
| Last Updated: | January 8, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency Australia: Department of Health and Ageing Therapeutic Goods Administration Denmark: Danish Medicines Agency France: L’Agence nationale de sécurité du médicament et des produits de santé New Zealand: Medsafe Japan: Ministry of Health, Labor and Welfare Israel: Israeli Health Ministry Pharmaceutical Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency Italy: The Italian Medicines Agency |
Keywords provided by Bayer:
|
Ciprofloxacin Dry Powder for Inhalation Exacerbation Bronchiectasis |
Additional relevant MeSH terms:
|
Bronchiectasis Fibrosis Bronchial Diseases Respiratory Tract Diseases Pathologic Processes Ciprofloxacin |
Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013