Trial document

PLEASE NOTE:
This study has been imported from ClinicalTrials.gov without additional data checks.

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DRKS-ID: DRKS00007335

Trial Description

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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.

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Trial Acronym

RESPIRE 2

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

[---]*

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Organizational Data

DRKS-ID: DRKS00007335
Date of Registration in DRKS: 2016/03/04
Date of Registration in Partner Registry or other Primary Registry: 2014/04/04
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]*
(leading) Ethics Committee No.: [---]*

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Secondary IDs

EudraCT-No. (for studies acc. to Drug Law): 2013-004659-19
Primary Registry-ID: NCT02106832 (ClinicalTrials.gov)
Sponsor-ID: 15626 (Bayer)
Other Secondary-ID: 2013-004659-19

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Health Condition or Problem studied

Free text: Bronchiectasis
ICD10: J47 - Bronchiectasis

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Interventions/Observational Groups

Arm 1: Drug: Ciprofloxacin: administered for 28 days on / 28 days off
Arm 2: Drug: Placebo: administered for 28 days on / 28 days off
Arm 3: Drug: Ciprofloxacin: administered for 14 days on / 14 days off
Arm 4: Drug: Placebo: administered for 14 days on / 14 days off

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject, caregiver, investigator/therapist, assessor
Control: Placebo
Purpose: Treatment
Assignment: Parallel
Phase: III
Off-label Drug use: [---]*

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Primary Outcome

- Time to first exacerbation; time frame: over 48 weeks after baseline; Description: Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics

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Secondary Outcome

- Mean number of exacerbations per patient per 48 weeks; time frame: over 48 weeks after baseline; Description: 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
- Quality of Life: Changes of Saint George's Respiratory; time frame: Baseline and 48 weeks
- New pathogens at 48 weeks, not present at baseline; time frame: Baseline and 48 weeks
- Changes of Forced Expiratory Volume in 1 second from baseline; time frame: Baseline and 48 weeks
- Number of participants with Adverse events as a measure of; time frame: up to 58 weeks after screening

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Countries of Recruitment

US: United States
AR: Argentina
AU: Australia
AT: Austria
BR: Brazil
BG: Bulgaria
CN: China
CZ: Czech Republic
DE: Germany
HK: Hong Kong
KR: Korea, Republic of
LV: Latvia
LT: Lithuania
NL: Netherlands
PL: Poland
PT: Portugal
RO: Romania
RU: Russian Federation
ZA: South Africa
TW: Taiwan, Province of China
TH: Thailand
TR: Turkey

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Locations of Recruitment

Hannover
Gelsenkirchen
Leipzig
Bad Berka
Berlin
Berlin
Berlin

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Recruitment

Planned/Actual: [---]*
(Anticipated or Actual) Date of First Enrollment: 2014/04/30
Target Sample Size: 300
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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Additional 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

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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)

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Addresses

Primary Sponsor
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- Bayer
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- Novartis
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Bayer
- Bayer Study Director
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Public Queries
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- Bayer Clinical Trials Contact
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- Telephone: (+)1-888-84 22937
- Fax: [---]*
- E-mail: clinical-trials-contact at bayerhealthcare.com
- URL: [---]*
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Sources of Monetary or Material Support

[---]*
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

Further trial documents: Click here and search for drug information provided by the FDA.
Further trial documents: Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .

Translation on version: 1
Last processed date by ClinicalTrials.gov: 2014/11/05

* This entry means the parameter is not applicable or has not been set.