Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)

PHASE3CompletedINTERVENTIONAL
Enrollment

521

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

September 13, 2016

Study Completion Date

October 19, 2016

Conditions
Bronchiectasis
Interventions
DRUG

Ciprofloxacin (BAYQ3939) dry powder for inhalation

Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.

DRUG

Ciprofloxacin (BAYQ3939) dry powder for inhalation

Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.

DRUG

Placebo

Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off

DRUG

Placebo

Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off

Trial Locations (207)

613

Chiayi City

807

Kaohsiung City

1000

Sofia

Manila

1012

Manila

1425

Capital Federal

1606

Sofia

1638

Vicente López

2000

City of San Fernando

2092

Johannesburg

2217

Kogarah

2305

New Lambton Heights

3050

Parkville

3320

Kozloduy

4127

eManzimtoti

5020

Salzburg

5041

Adelaide

5042

Adelaide

5300

Gabrovo

5400

Sevlievo

5500

Lovech

5501

Godoy Cruz

5601

Krāslava

6000

Stara Zagora

6009

Perth

6150

Murdoch

7000

Rousse

7200

Razgrad

7500

Cape Town

7764

Cape Town

8036

Graz

8800

Sliven

10002

Taipei

10400

Bangkok

10700

Bangkok

10717

Berlin

11000

Belgrade

11080

Belgrade

11229

Brooklyn

11501

Mineola

14000

Valjevo

14059

Berlin

14929

Treuenbrietzen

18204

Knez-Selo

18901

Doylestown

21204

Kamenitz

21565

Incheon

22767

Hamburg

23561

New Taipei City

25000

Sombor

27310

Şehitkamil

28801

Asheville

29615

Greenville

30000

NakhonRatchasima

30033

Decatur

30173

Hanover

30625

Hanover

32000

Čačak

33126

Miami

33343

Mersin

33613

Tampa

34000

Kragujevac

34239

Sarasota

34741

Kissimmee

34844

Maltepe

34890

Pendik

35040

Izmir

40002

Khon Kaen

40447

Taichung

41000

Udon Thani

42080

Konya

42415

Daegu

45879

Gelsenkirchen

50200

Chiang Mai

55139

Samsun

55905

Rochester

60076

Skokie

60389

Frankfurt am Main

63263

Neu-Isenburg

65000

Phitsanulok

66061

Olathe

78539

Edinburg

85381

Peoria

90708

Fountain Valley

90813

Long Beach

92037

La Jolla

92120

San Diego

92663

Newport Beach

97239

Portland

99437

Bad Berka

100029

Beijing

100144

Beijing

100184

Ploieşti

105229

Moscow

110004

Shenyang

115682

Moscow

127015

Moscow

129090

Moscow

150003

Yaroslavl

163001

Arkhangelsk

194295

Saint Petersburg

194356

Saint Petersburg

196084

Saint Petersburg

200032

Shanghai

200040

Shanghai

200433

Shanghai

214023

Wuxi

215006

Suzhou

300310

Timișoara

330006

Nanchang

350025

Fuzhou

394066

Voronezh

400042

Chongqing

450071

Ufa

454076

Chelyabinsk

500086

Brasov

505100

Codlea

510120

Guangzhou

603035

Nizhny Novgorod

610041

Chengdu

630047

Novosibirsk

630075

Novosibirsk

630087

Novosibirsk

634063

Tomsk

700141

Iași

750004

Yinchuan

900002

Constanța

50920640

Recife

75708-3154

Tyler

C1425DES

Buenos Aires

X5003DCE

Córdoba

30150-221

Belo Horizonte

90610-000

Porto Alegre

90880-480

Porto Alegre

04266-010

São Paulo

90035-074

Porto Alegre

01244-030

São Paulo

05403-900

São Paulo

010050

Hohehot

625 00

Brno

121 11

Prague

140 46

Prague

180 81

Prague

04357

Leipzig

07740

Jena

Unknown

Hong Kong

Kowloon

New Territories

Shatin

LV-5403

Daugavpils

LV-5410

Daugavpils

LV-2010

Jūrmala

LV-1001

Riga

LV-1002

Riga

LV-1011

Riga

LV-1038

Riga

LV-3201

Talsi

LT-92288

Klaipėda

LT-08661

Vilnius

1815 JD

Alkmaar

9403 RK

Assen

9728 NT

Groningen

5707 HA

Helmond

6229 HX

Maastricht

6162 BG

Sittard-Geleen

5500 MB

Veldhoven

NCR 1100

Quezon City

NCR 1104

Quezon City

43-300

Bielsko-Biala

42-200

Częstochowa

66-400

Gorzów Wielkopolski

86-300

Grudziądz

40-954

Katowice

25-035

Kielce

25-734

Kielce

25-751

Kielce

31-455

Krakow

95-054

Ksawerów

05-320

Mrozy

27-400

Ostrowiec Świętokrzyski

35-301

Rzeszów

01-868

Warsaw

9701-856

Angra do Heroísmo

4434-502

Vila Nova de Gaia

8000-386

Faro

1649-035

Lisbon

1769-001

Lisbon

077025

Bragadiru

010457

Bucharest

011461

Bucharest

030303

Bucharest

050159

Bucharest

821 06

Bratislava

080 01

Prešov

301-723

Daejeon

420-717

Bucheon-si

403-720

Incheon Gwangyeogsi,

135-720

Seoul

03080

Seoul

100-032

Seoul

120-752

Seoul

130-872

Seoul

136-705

Seoul

061100

Ankara

06110

Ankara

01330

Balcalı

07058

Kampus

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Bayer

INDUSTRY