Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis

PHASE4CompletedINTERVENTIONAL
Enrollment

1,372

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Chronic Bronchitis
Interventions
DRUG

Avelox (Moxifloxacin, BAY12-8039)

Subjects will be randomised to moxifloxacin 400 mg PO OD (5 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.

DRUG

Amoxicillin clavulanic acid

Subjects will be randomised to amoxicillin-clavulanic acid 875/125 mg PO BID (7 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.

Trial Locations (220)

31

Lima

33

Lima

1009

Riga

1011

Riga

1020

Bruxelles - Brussel

1035

Witbank

1050

Riga

1426

Buenos Aires

1500

Benoni

1610

Kempton Park

1638

Vicente López

2018

Antwerp

2139

Concord

3004

Bern

3201

Talsu

3545

Halen

3600

Thun

3920

Lommel

4000

San Miguel de Tucumán

4031

Basel

4037

Durban

4091

Durban

4101

Brisbane

4102

Binningen

4104

Oberwil

4200

Porto

4201

Valmiera

4242

Laufen

5000

Namur

Aarau

5011

Woodville

5041

Adelaide

5430

Wettingen

5530

Yvoir

5601

Krāslava

6009

Nedlands

6014

Port Elizabeth

7130

Somerset West

7505

Cape Town

7647

Paarl

8048

Zurich

8091

Zurich

8340

Moerkerke

9300

Aalst

9324

Bloemfontein

10000

Zagreb

10330

Bangkok

10365

Berlin

10717

Berlin

10969

Berlin

11000

Nonthaburi

11527

Athens

12043

Berlin

12203

Berlin

13009

Marseille

13230

Jakarta

13597

Berlin

14059

Berlin

15562

Rüdersdorf

15806

Zossen

17033

Neubrandenburg

19002

Guadalajara

20123

Milan

20157

Milan

20354

Hamburg

21052

Busto Arsizio

22305

Hamburg

23552

Lübeck

23795

Bad Segeberg

28040

Madrid

31350

Chihuahua City

36039

Fulda

37012

Bussolengo

40000

Mont-de-Marsan

41110

Mezourlo

44280

Guadalajara

45500

Ioannina

46340

Requena

50200

Chiang Mai

56564

Neuwied

58515

Lüdenscheid

60318

Frankfurt am Main

60389

Frankfurt am Main

63100

Ascoli Piceno

64718

Monterrey

66025

Perpignan

66100

Chieti

66480

Monterrey

74800

Karachi

75500

Karachi

76231

Šiauliai

78073

Bad Dürrheim

84013

Pregiato Di Cava Dei Tirreni

86150

Augsburg

95122

Catania

97001

Mérida

98608

Zacatecas City

100020

Beijing

100050

Beijing

110001

Shenyang

110004

Shengyang

200003

Shanghai

200040

Shanghai

200233

Shanghai

300052

Tianjin

410013

Changsha

510120

Guangzhou

510405

Guangzhou

610041

Chengdu

Unknown

Les Escaldes

Quilmes

San Juan Bautista

Buenos Aires

San Miguel de Tucumán

Santiago

Valparaíso

Viña del Mar

Cali

Bogotá

Bucaramanga

Medellín

Santiago de Cali

Hong Kong

Kowloon

Bandung

Surabaya

Killarney

Longford

Enniscorthy

Gorey

Bray

Kaunas

Islamabad

Lima

Manila

Quezon City

Pretoria

Glasgow

C1424BSF

Buenos Aires

C1425AWC

Buenos Aires

36036-110

Juiz de Fora

90610-000

Porto Alegre

04032-060

São Paulo

05403-900

São Paulo

T2N 4Z6

Calgary

T6G 2B7

Edmonton

T6L 5X8

Edmonton

V1Y 8E7

Kelowna

V5Z 4E1

Vancouver

R3A 1R8

Winnipeg

R3C 0N2

Winnipeg

E2K 2T8

Saint John

E2M 3W5

Saint John

B2G 2C2

Antigonish

B1V 2Y5

Sydney Mines

L7R 3X4

Burlington

L8N 4A6

Hamilton

N6A 4V2

London

N6A 5G6

London

M6H 3M2

Toronto

J4N 1E1

Longueuil

H2L 4M1

Montreal

JIH 4J6

Sherbrooke

310 00

Osijek

44 250

Petrinja

510 00

Rijeka

697 01

Kyjov

410 02

Lovosice

227 11

Neratovice

530 09

Pardubice - Trnova

108 00

Praha - Malesice

182 00

Praha - Troja

06000

Nice

03050

Cottbus

04564

Böhlen

04509

Delitzsch

01307

Dresden

04207

Leipzig

04275

Leipzig

04357

Leipzig

01662

Meissen

106 76

Athens

265 04

Rio

06156

Perugia

LV-3601

Ventspils

LT-50425

Kaunas

LT-94231

Klaipėda

LT-06122

Vilnius

LT-07156

Vilnius

CP 52763

Huixquilucan

5623 EJ

Eindhoven

6419 PC

Heerlen

2134 TM

Hoofddorp

7943 KA

Meppel

3582 KE

Utrecht

LIMA 18

Lima

CALLAO 2

Callao

LIMA 27

Lima

3000-075

Coimbra

2560-324

Torres Vedras

4454-509

Matosinhos Municipality

4434-502

Vila Nova de Gaia

1169-024

Lisbon

1649-035

Lisbon

3041-856

S. Martinho Do Bispo

2005-177

Santarém

0140

Centurion

0002

Pretoria

0084

Pretoria

0380

Thabazimbi

08916

Badalona

08034

Barcelona

08036

Barcelona

08830

Sant Boi de Llobregat

07010

Palma de Mallorca

G3 8YJ

Glasgow

G45 9AW

Glasgow

G46 8NY

Glasgow

G69 7AD

Glasgow

CV7 8LA

Coventry

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT00656747 - Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis | Biotech Hunter | Biotech Hunter