Clinical trial NCT02106832: Ciprofloxacin Dry Powder for Inhalation (DPI) 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: 2014-04-08
Enrollment: 521
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.

Eligibility 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)

Primary outcomes:
measure: Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo
timeFrame: Up to Week 48
measure: Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo
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: Peoria
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: San Diego
country: United States
state: California
city: Kissimmee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Skokie
country: United States
state: Illinois
city: Olathe
country: United States
state: Kansas
city: Rochester
country: United States
state: Minnesota
city: Brooklyn
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Doylestown
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Edinburg
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Capital Federal
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Godoy Cruz
country: Argentina
state: Mendoza
city: Córdoba
country: Argentina
city: Vicente López
country: Argentina
city: Kogarah
country: Australia
state: New South Wales
city: New Lambton Heights
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: Adelaide
country: Australia
state: South Australia
city: Parkville
country: Australia
state: Victoria
city: Murdoch
country: Australia
state: Western Australia
city: Perth
country: Australia
state: Western Australia
city: Graz
country: Austria
city: Salzburg
country: Austria
city: Belo Horizonte
country: Brazil
state: Minas Gerais
city: Recife
country: Brazil
state: Pernambuco
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: São Paulo
country: Brazil
state: Sao Paulo
city: Porto Alegre
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Gabrovo
country: Bulgaria
city: Kozloduy
country: Bulgaria
city: Lovech
country: Bulgaria
city: Razgrad
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sevlievo
country: Bulgaria
city: Sliven
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Fuzhou
country: China
state: Fujian
city: Guangzhou
country: China
state: Guangdong
city: Hohehot
country: China
state: Inner Mongolia
city: Suzhou
country: China
state: Jiangsu
city: Wuxi
country: China
state: Jiangsu
city: Nanchang
country: China
state: Jiangxi
city: Shenyang
country: China
state: Liaoning
city: Yinchuan
country: China
state: Ningxia
city: Chengdu
country: China
state: Sichuan
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Brno
country: Czechia
city: Prague 4
country: Czechia
city: Praha 2
country: Czechia
city: Praha 8
country: Czechia
city: Treuenbrietzen
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: Gelsenkirchen
country: Germany
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
state: Sachsen
city: Bad Berka
country: Germany
state: Thüringen
city: Jena
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hong Kong
country: Hong Kong
city: Kowloon
country: Hong Kong
city: New Territories
country: Hong Kong
city: Shatin
country: Hong Kong
city: Daejeon
country: Korea, Republic of
state: Daejeon Gwang''yeogsi
city: Bucheon
country: Korea, Republic of
state: Gyeonggido
city: Incheon Gwangyeogsi,
country: Korea, Republic of
state: Incheon Gwang''yeogsi
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
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: Talsi
country: Latvia
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Alkmaar
country: Netherlands
city: Assen
country: Netherlands
city: Groningen
country: Netherlands
city: Helmond
country: Netherlands
city: Maastricht
country: Netherlands
city: Sittard-Geleen
country: Netherlands
city: Veldhoven
country: Netherlands
city: City of San Fernando
country: Philippines
city: Manila
country: Philippines
city: Manila
country: Philippines
city: Quezon City
country: Philippines
city: Quezon City
country: Philippines
city: Bielsko-Biala
country: Poland
city: Czestochowa
country: Poland
city: Gorzow Wielkopolski
country: Poland
city: Grudziadz
country: Poland
city: Katowice
country: Poland
city: Kielce
country: Poland
city: Kielce
country: Poland
city: Kielce
country: Poland
city: Krakow
country: Poland
city: Ksawerow
country: Poland
city: Mrozy
country: Poland
city: Ostrowiec Swietokrzyski
country: Poland
city: Rzeszow
country: Poland
city: Warszawa
country: Poland
city: Vila Nova de Gaia
country: Portugal
state: Porto
city: Angra do Heroísmo
country: Portugal
state: Região Autónoma dos Açores
city: Faro
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Bragadiru
country: Romania
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Codlea
country: Romania
city: Constanta
country: Romania
city: Iasi
country: Romania
city: Ploiesti
country: Romania
city: Timisoara
country: Romania
city: Arkhangelsk
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Ufa
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Cacak
country: Serbia
city: Knez Selo
country: Serbia
city: Kragujevac
country: Serbia
city: Sombor
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Valjevo
country: Serbia
city: Bratislava
country: Slovakia
city: Presov
country: Slovakia
city: Johannesburg
country: South Africa
state: Gauteng
city: Amanzimtoti
country: South Africa
state: Kwazulu-Natal
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Chiayi
country: Taiwan
city: Kaohsiung
country: Taiwan
city: New Taipei City,
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiangmai
country: Thailand
city: Khon Kaen
country: Thailand
city: NakhonRatchasima
country: Thailand
city: Phitsanulok
country: Thailand
city: Udonthani
country: Thailand
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Balcali
country: Turkey
city: Izmir
country: Turkey
city: Kampus
country: Turkey
city: Konya
country: Turkey
city: Maltepe
country: Turkey
city: Mersin
country: Turkey
city: Pendik
country: Turkey
city: Samsun
country: Turkey
city: Sehitkamil
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Aksamit T, De Soyza A, Bandel TJ, Criollo M, Elborn JS, Operschall E, Polverino E, Roth K, Winthrop KL, Wilson R. RESPIRE 2: 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):1702053. doi: 10.1183/13993003.02053-2017. 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.