Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00473460

Collaborator

(none)

1,404

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate, and it is expected that the study will run for 2 years in order to reach that goal. The patients individual involvement in the study will be 17 months. Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication (moxifloxacin or placebo) will be taken in addition to the patients normal medication for chronic bronchitis. In addition to the first clinic visit, called a screening visit, the patient will be required to come back to the clinic for ten more study visits, every 8 weeks. At the first visit the study co-ordinator will provide him with the dates for all the visits. Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will receive the study medication which he will take for five days, in addition to his normal treatment for chronic bronchitis. After this time the patient will enter a follow up period for 24 weeks, where he will come to the clinic for assessments and continue to take his normal medication but not receive the study drug. A complete medical history will be taken at the first visit, including the patients past and current smoking habit. A breath test will be performed to assess how well his lungs are functioning. In addition, he will also be asked to provide a sputum sample for a microbiological examination to identify any bacteria present in the sample. The patient must be able to provide a sputum sample at the screening visit. If the patient meets all the inclusion / exclusion criteria for the study, he will be allocated randomly to one of the following treatment groups at the second visit.- Treatment group 1: Receives moxifloxacin orally once daily for five days.- Treatment group 2: Receives a matching placebo once daily for five days.In between each visit (four weeks after your clinic visit), the study site co-ordinator will contact the patient to check on his well being. If the patient or the doctor decides to stop the patients participation in the trial for any reason, the patient will be required to return to the clinic for a physical examination, take a breath test, provide a sputum sample (if possible) and have a blood sample taken.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases Bronchitis, Chronic	Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1404 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

A Double-blind, Randomized, Placebo-controlled Study to Investigate Chronic Intermittent-pulse-therapy of Moxifloxacin as a Prevention of Acute in Exacerbation Out-patients With Chronic Bronchitis.

Study Start Date :

Oct 1, 2004

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Avelox (Moxifloxacin, BAY12-8039) Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks
Placebo Comparator: Arm 2	Drug: Placebo Matching placebo capsules orally once daily for 5 days every 8 weeks.

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Avelox (Moxifloxacin, BAY12-8039)

Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks

Placebo Comparator: Arm 2

Drug: Placebo

Matching placebo capsules orally once daily for 5 days every 8 weeks.

Outcome Measures

Primary Outcome Measures

Number of exacerbations after 48 weeks of intermittent pulse treatment [After 48 weeks of treatment]

Secondary Outcome Measures

Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scores [At week 48]
Deterioration in lung function test (PFEV1) [At week 48]
Frequency of hospitalisation [At week 48]
Mortality rates [At week 48]
Time of first exacerbation [Through to week 48]
Frequency of acute exacerbation of chronic bronchitis [At week 24 and 72 (end of follow-up)]
Time to next exacerbation from last pulsed dose [At week 48]
Length of exacerbations [Through to week 48]
Percentage of exacerbation free time [Through to week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female out-patients >/= 45 years
Subjects suffering from chronic bronchitis
FEV1</= 70% and FEV1/FVC </= 70% predicted from age, height and sex
No documented episode of AECB (requiring treatment) within 6 weeks of randomization and not experiencing an exacerbation at the time of screening
Sputum production on most days, even when exacerbation free
Subjects presented with at least two documented (i.e. requiring antibiotics and/or systemic steroid administration) acute exacerbation episodes during the last 12 monthsIf receiving chronic therapy with inhaled long acting bronchodilators and/or inhaled or systemic steroids, the treatment must have remained stable for the preceding 6 weeks prior to screening
Smoking history of at least 20 pack-years
Subjects willing and able to give fully informed written consent

Exclusion Criteria:

Subjects with contra-indications to moxifloxacin- Known bronchial carcinoma, pulmonary tuberculosis, cystic fibrosis, documented chronic bronchial asthma or diffuse bronchiectasis- Subjects who are actively participating in intensive pulmonary rehabilitation programs
Subjects with a known history of chronic colonization of pathogenic organisms resistant to moxifloxacin, e.g. Pseudomonas spp, MRSA
No systemic or inhaled antibiotic therapy during the 6 weeks prior to screening and any long term antibiotic usage
Subjects requiring home ventilatory support for COPD and those who have a tracheostomy in situ (subjects requiring home/potable oxygen therapy or CPAP for sleep apnea can be included)

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Tucson	Arizona	United States	85723
2	Long Beach	California	United States	90822-5201
3	Los Angeles	California	United States	90073-1003
4	Bay Pines	Florida	United States	33744
5	Kansas City	Missouri	United States	64128-2295
6	Buffalo	New York	United States	14215-1129
7	Dallas	Texas	United States	75216-7167
8	Houston	Texas	United States	77024
9	Houston	Texas	United States	77030
10	San Antonio	Texas	United States	78284-5799
11	Richmond	Virginia	United States	23249-0002
12	Escaldes - Engordany		Andorra
13	Florencio Varela	Buenos Aires	Argentina	1888
14	Buenos Aires	Capital Federal	Argentina	1416
15	Buenos Aires	Capital Federal	Argentina	1426
16	Buenos Aires	Capital Federal	Argentina	C1120AAF
17	Juiz de Fora	MG	Brazil	36036-110
18	Porto Alegre	RS	Brazil	90610-000
19	Sao Paulo	SP	Brazil	04023-900
20	Sao Paulo	SP	Brazil	05403-900
21	Santiago		Chile
22	Valparaiso		Chile	236-3058
23	Arras		France	62000
24	Mont-de-marsan		France	40000
25	Nice		France	06000
26	Orthez		France	64300
27	Rosiers D'egletons		France	19300
28	Strasbourg		France	67000
29	Kaufbeuren	Bayern	Germany	87600
30	Gelnhausen	Hessen	Germany	63571
31	Hannover	Niedersachsen	Germany	30159
32	Rotenburg	Niedersachsen	Germany	27356
33	Witten	Nordrhein-Westfalen	Germany	58452
34	Neuwied	Rheinland-Pfalz	Germany	56564
35	Bad Segeberg	Schleswig-Holstein	Germany	23795
36	Berlin		Germany	10717
37	Berlin		Germany	10969
38	Berlin		Germany	12043
39	Hamburg		Germany	20535
40	Rio	Patras	Greece	265 04
41	Athens		Greece	11527
42	Dublin		Ireland	8
43	Dublin		Ireland	DUBLIN 7
44	Afula		Israel	18101
45	Ashkelon		Israel	78306
46	Bat Yam		Israel	59512
47	Tel Aviv		Israel	64239
48	Ferrara		Italy	44100
49	Milano		Italy	20123
50	Milano		Italy	20157
51	Pavia		Italy	27100
52	Guadalajara	Jalisco	Mexico	44280
53	Mérida	Yucatán	Mexico	97001
54	Mérida	Yucatán	Mexico	97070
55	Chihuahua		Mexico	31350
56	Bloemfontein	Free State	South Africa	9300
57	Bloemfontein	Free State	South Africa	9301
58	Johannesburg	Gauteng	South Africa	2057
59	Pretoria	Gauteng	South Africa	0040
60	Pretoria	Gauteng	South Africa	0157
61	Durban	KwaZulu Natal	South Africa	4091
62	Cape Town	Western Cape	South Africa	7531
63	Cape Town	Western Cape	South Africa	7569
64	Paarl	Western Cape	South Africa	7646
65	Badalona	Barcelona	Spain	08916
66	Ronda	Málaga	Spain	29400
67	Barcelona		Spain	08036
68	Madrid		Spain	28040
69	Valencia		Spain	46009
70	Valladolid		Spain	47010
71	Bristol	Avon	United Kingdom	BS10 5NB
72	London	Greater London	United Kingdom	E1 2AT
73	London	Greater London	United Kingdom	E2 9JX
74	London	Greater London	United Kingdom	NW3 2QG
75	London	Greater London	United Kingdom	SW17 0QT
76	London	Greater London	United Kingdom	SW3 6NP
77	Birmingham	West Midlands	United Kingdom	B15 2TH
78	Leeds	West Yorkshire	United Kingdom	LS9 7TF