Clinical trial NCT01764841: Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchiectasis
Keywords: Ciprofloxacin
Dry Powder for Inhalation
Exacerbation
Bronchiectasis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2013-01-10
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Time to First Exacerbation Event Within 48 Weeks
timeFrame: Up to Week 48
Secondary outcomes:
measure: Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks
timeFrame: Up to Week 48
measure: Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks
timeFrame: Up to Week 48
measure: Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)
timeFrame: End of treatment (Week 44/46)
measure: Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)
timeFrame: Baseline and end of treatment (Week 44/46)
measure: Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)
timeFrame: End of treatment (Week 44/46)
measure: 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)
timeFrame: Baseline and end of treatment (Week 44/46)
measure: Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)
timeFrame: Baseline and end of treatment (Week 44/46)
Other outcomes:
Locations:
city: Jasper
country: United States
state: Alabama
city: Flagstaff
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Fort Smith
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Torrance
country: United States
state: California
city: Ventura
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Celebration
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Lawrenceville
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Michigan City
country: United States
state: Indiana
city: Hazard
country: United States
state: Kentucky
city: Chesterfield
country: United States
state: Missouri
city: Summit
country: United States
state: New Jersey
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Kingwood
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Abingdon
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Buenos Aires
country: Argentina
state: Ciudad Auton. De Buenos Aires
city: Godoy Cruz
country: Argentina
state: Mendoza
city: Vicente López
country: Argentina
city: Woolloongabba
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Adelaide
country: Australia
state: South Australia
city: Woodville
country: Australia
state: South Australia
city: Parkville
country: Australia
state: Victoria
city: Prahran
country: Australia
state: Victoria
city: Murdoch
country: Australia
state: Western Australia
city: Box Hill
country: Australia
city: Cairns
country: Australia
city: Frankston
country: Australia
city: Kogarah
country: Australia
city: Toorak Gardens
country: Australia
city: Aarhus C
country: Denmark
city: Hellerup
country: Denmark
city: Naestved
country: Denmark
city: Roskilde
country: Denmark
city: Clermont Ferrand
country: France
city: Montpellier
country: France
city: Nimes
country: France
city: Toulon
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Cottbus
country: Germany
state: Brandenburg
city: Frankfurt
country: Germany
state: Hessen
city: Neu-Isenburg
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Hannover
country: Germany
state: Niedersachsen
city: Koblenz
country: Germany
state: Rheinland-Pfalz
city: Geesthacht
country: Germany
state: Schleswig-Holstein
city: Jena
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petah Tikva
country: Israel
city: Ramat Gan
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Benevento
country: Italy
state: Campania
city: Trieste
country: Italy
state: Friuli-Venezia Giulia
city: Roma
country: Italy
state: Lazio
city: Pavia
country: Italy
state: Lombardia
city: Varese
country: Italy
state: Lombardia
city: Bari
country: Italy
state: Puglia
city: Cagliari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Pisa
country: Italy
state: Toscana
city: Verona
country: Italy
state: Veneto
city: Toon
country: Japan
state: Ehime
city: Nakagun
country: Japan
state: Ibaraki
city: Koshi
country: Japan
state: Kumamoto
city: Matsusaka
country: Japan
state: Mie
city: Tsu
country: Japan
state: Mie
city: Sakai
country: Japan
state: Osaka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Kiyose
country: Japan
state: Tokyo
city: Mitaka
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Daugavpils
country: Latvia
city: Daugavpils
country: Latvia
city: Jurmala
country: Latvia
city: Kraslava
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Talsu
country: Latvia
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Dunedin
country: New Zealand
city: Hamilton
country: New Zealand
city: Tauranga
country: New Zealand
city: Wellington
country: New Zealand
city: Bratislava
country: Slovakia
city: Presov
country: Slovakia
city: Santiago de Compostela
country: Spain
state: A Coruña
city: Elda
country: Spain
state: Alicante
city: Oviedo
country: Spain
state: Asturias
city: Badalona
country: Spain
state: Barcelona
city: L'Hospitalet
country: Spain
state: Barcelona
city: Sant Boi de Llobregat
country: Spain
state: Barcelona
city: Terrassa
country: Spain
state: Barcelona
city: Pozuelo de Alarcón
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cáceres
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Pontevedra
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: Exeter
country: United Kingdom
state: Devon
city: Plymouth
country: United Kingdom
state: Devon
city: Torbay
country: United Kingdom
state: Devon
city: Dundee
country: United Kingdom
state: Dundee City
city: Belfast
country: United Kingdom
state: North Ireland
city: Shrewsbury
country: United Kingdom
state: Shropshire
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne And Wear
city: Londonderry
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: De Soyza A, Aksamit T, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J. 2018 Jan 25;51(1):1702052. doi: 10.1183/13993003.02052-2017. Print 2018 Jan.
citation: Aksamit T, Bandel TJ, Criollo M, De Soyza A, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis. Contemp Clin Trials. 2017 Jul;58:78-85. doi: 10.1016/j.cct.2017.05.007. Epub 2017 May 8.