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Lung DiseasesPhase 3NCT00473460

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

A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) in people with Lung Diseases and Bronchitis, Chronic, run by Bayer at 78 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 90 years
Conditions the study is for
Lung Diseases, Bronchitis, Chronic
What is being tested?
Avelox (Moxifloxacin, BAY12-8039)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,404 participants
Where
78 sitesin 15 countries
Study dates
Oct 2004to Jan 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

78 sites in 15 countries.

78 sites in 15 countries

United States11 sites

  • Study site

    Bay Pines, Florida, 33744

  • Study site

    Buffalo, New York, 14215-1129

  • Study site

    Dallas, Texas, 75216-7167

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77030

  • Study site

    Kansas City, Missouri, 64128-2295

  • Study site

    Long Beach, California, 90822-5201

  • Study site

    Los Angeles, California, 90073-1003

  • Study site

    Richmond, Virginia, 23249-0002

  • Study site

    San Antonio, Texas, 78284-5799

  • Study site

    Tucson, Arizona, 85723

Other trials in United States

Germany11 sites

  • Study site

    Bad Segeberg, Schleswig-Holstein, 23795

  • Study site

    Berlin, State of Berlin, 10717

  • Study site

    Berlin, State of Berlin, 10969

  • Study site

    Berlin, State of Berlin, 12043

  • Study site

    Gelnhausen, Hesse, 63571

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20535

  • Study site

    Hanover, Lower Saxony, 30159

  • Study site

    Kaufbeuren, Bavaria, 87600

  • Study site

    Neuwied, Rhineland-Palatinate, 56564

  • Study site

    Rotenburg (Wümme), Lower Saxony, 27356

  • Study site

    Witten, North Rhine-Westphalia, 58452

Other trials in Germany

South Africa9 sites

  • Study site

    Bloemfontein, Free State, 9300

  • Study site

    Bloemfontein, Free State, 9301

  • Study site

    Cape Town, Western Cape, 7531

  • Study site

    Cape Town, Western Cape, 7569

  • Study site

    Durban, KwaZulu-Natal, 4091

  • Study site

    Johannesburg, Gauteng, 2057

  • Study site

    Paarl, Western Cape, 7646

  • Study site

    Pretoria, Gauteng, 0040

  • Study site

    Pretoria, Gauteng, 0157

Other trials in South Africa

United Kingdom8 sites

  • Study site

    Birmingham, West Midlands, B15 2TH

  • Study site

    Bristol, Avon, BS10 5NB

  • Study site

    Leeds, West Yorkshire, LS9 7TF

  • Study site

    London, Greater London, E1 2AT

  • Study site

    London, Greater London, E2 9JX

  • Study site

    London, Greater London, NW3 2QG

  • Study site

    London, Greater London, SW17 0QT

  • Study site

    London, Greater London, SW3 6NP

Other trials in United Kingdom

France6 sites

  • Study site

    Arras, 62000

  • Study site

    Mont-de-Marsan, 40000

  • Study site

    Nice, 06000

  • Study site

    Orthez, 64300

  • Study site

    Rosiers-d'Égletons, 19300

  • Study site

    Strasbourg, 67000

Other trials in France

Spain6 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Ronda, Málaga, 29400

  • Study site

    Valencia, Valencia, 46009

  • Study site

    Valladolid, Valladolid, 47010

Other trials in Spain

Argentina4 sites

  • Study site

    Buenos Aires, Buenos Aires F.D., 1416

  • Study site

    Buenos Aires, Buenos Aires F.D., 1426

  • Study site

    Buenos Aires, Buenos Aires F.D., C1120AAF

  • Study site

    San Juan Bautista, Buenos Aires, 1888

Other trials in Argentina

Brazil4 sites

  • Study site

    Juiz de Fora, Minas Gerais, 36036-110

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    São Paulo, São Paulo, 04023-900

  • Study site

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

Israel4 sites

  • Study site

    Afula, Israel, 18101

  • Study site

    Ashkelon, Israel, 78306

  • Study site

    Bat Yam, Israel, 59512

  • Study site

    Tel Aviv, Israel, 64239

Other trials in Israel

Italy4 sites

  • Study site

    Ferrara, 44100

  • Study site

    Milan, 20123

  • Study site

    Milan, 20157

  • Study site

    Pavia, 27100

Other trials in Italy

Mexico4 sites

  • Study site

    Chihuahua City, Chihuahua, 31350

  • Study site

    Guadalajara, Jalisco, 44280

  • Study site

    Mérida, Yucatán, 97001

  • Study site

    Mérida, Yucatán, 97070

Other trials in Mexico

Chile2 sites

  • Study site

    Santiago

  • Study site

    Valparaíso, 236-3058

Other trials in Chile

Greece2 sites

  • Study site

    Athens, 11527

  • Study site

    Rio, Patras, 265 04

Other trials in Greece

Ireland2 sites

  • Study site

    Dublin, Dublin, 8

  • Study site

    Dublin, DUBLIN 7

Other trials in Ireland

Andorra1 site

  • Study site

    Les Escaldes

About this study

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.

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.

Being tested
Avelox (Moxifloxacin, BAY12-8039), Placebo
Keywords
Chronic bronchitis, Chronic obstructive pulmonary disease, Acute exacerbation of chronic bronchitis, Prevention therapy, Antibiotics, Fluoroquinolone, Moxifloxacin, AECB
Medical subject headings
Lung Diseases, Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avelox (Moxifloxacin, BAY12-8039)Drug

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

  • PlaceboDrug

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

Study groups in NCT00473460
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Avelox (Moxifloxacin, BAY12-8039)
Arm 2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of exacerbations after 48 weeks of intermittent pulse treatment

    Measured: After 48 weeks of treatment

Secondary outcomes (9)

  1. Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scores

    Measured: At week 48

  2. Deterioration in lung function test (PFEV1)

    Measured: At week 48

  3. Frequency of hospitalisation

    Measured: At week 48

  4. Mortality rates

    Measured: At week 48

  5. Time of first exacerbation

    Measured: Through to week 48

  6. Frequency of acute exacerbation of chronic bronchitis

    Measured: At week 24 and 72 (end of follow-up)

  7. Time to next exacerbation from last pulsed dose

    Measured: At week 48

  8. Length of exacerbations

    Measured: Through to week 48

  9. Percentage of exacerbation free time

    Measured: Through to week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2007 (estimated)
  2. Study startOct 2004
  3. Primary completionJan 2007
  4. Study completionJan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,404 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00473460
Sponsor's protocol ID
11229
Other IDs
EudraCT No: 2004-000404-40
Status last verified
Oct 2014
First submitted
14 May 2007
Last updated
28 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • Sethi S, Jones PW, Theron MS, Miravitlles M, Rubinstein E, Wedzicha JA, Wilson R; PULSE Study group. Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial. Respir Res. 2010 Jan 28;11(1):10. doi: 10.1186/1465-9921-11-10.

    PubMed 20109213

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Avelox (Moxifloxacin, BAY12-8039) in people with Lung Diseases and Bronchitis, Chronic, run by Bayer at 78 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Germany, South Africa, United Kingdom, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of exacerbations after 48 weeks of intermittent pulse treatment (time frame: After 48 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00473460, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.

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