Moxifloxacin for the Treatment of Acute Exacerbation of Chronic Bronchitis

Condition(s) targeted: Chronic Bronchitis

Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug); Amoxicillin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.

Official title: MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations of Chronic Bronchitis.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary efficacy variable is clinical failure at 8 weeks post therapy.

Secondary outcome:

The secondary efficacy variables are:- clinical efficacy rates at the During Therapy, EOT, and 4 weeks Post therapy

Bacteriological eradication rates at During Therapy, EOT, 4 weeks Post therapy, and 8 weeks Post therapy visits

Clinical efficacy rates for subjects with positive sputum culture at enrollment at the During Therapy, EOT, 4 weeks Post therapy, and 8 weeks Post therapy visits

Weekly mean symptom scores measured by the AECB SS

Rates and speed of symptom relief measured by the AECB SS

Need for any change in dosage or additional respiratory medication such as bronchodilators and inhaled steroids, excluding short acting bronchodilators

Improvement in symptoms burden measured by the AECB SS

Improvement in health related QoL measured by the SGRQ

Lung function test will be compared between treatment groups at each assessment visit

HCRU related to chronic bronchitis management including rescue medications, concomitant medications, therapeutic adjuncts, diagnostic procedures,

Other medical care/medical staff requirement, hospitalizations (including ward and duration), and work productivity and activity impairment

Safety and tolerability of moxifloxacin versus amoxicillin clavulanic acid, with particular attention to rates of diarrhea

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatients

- Male or female subjects, >/=60 years old

- Subject who can be managed with oral antimicrobials

- FEV1>/=50% predicted at enrollment in addition to a historical record of FEV1 of

>/=60% within the past 12 months obtained during a stable infection-free period. A historical record of FEV1 is not required if the enrollment FEV1 is >/=50%.

- Documented history of 2 or more AECB episodes, within 12 months of study enrollment,

requiring a course of systemic antibiotics and/or systemic corticosteroids

- All symptoms/signs must be present and confirmed by the Investigator:

- Increase in dyspnea

- Purulent sputum

- Increase in sputum volume

- Subject must provide a purulent sputum sample by deep expectoration prior to

randomization for Gram stain, culture and sensitivity testing. The sputum will be assessed macroscopically by the investigator and graded according to the provided color chart.

- Current or past cigarette smoker with >/=20 pack year smoking history

- Subjects must have an infection-free interval of at least 30 days prior to enrollment

- Subjects must be willing and able to complete the questionnaires and subject booklet

without assistance

- Subjects with medical conditions and social status at the time of enrollment

compatible with study protocol procedures

- Willing and able to provide written informed consent

Exclusion Criteria:

- Known hypersensitivity to quinolones, ß-lactams, or to any of the excipients of the

study drugs

- Known to have congenital or acquired QT prolongation

- Known to have clinically relevant bradycardia

- Known to have clinically relevant heart failure with reduced left ventricular

ejection fraction

- Known to have previous history of symptomatic arrhythmias

- Taking QT prolonging drugs

- Known electrolyte disturbances that are not controlled, particularly uncorrected

hypokalemia

- Known history of hereditary problems of galactose intolerance, the Lapp lactase

deficiency, or glucose galactose malabsorption

- Requiring hemodialysis

- History of a tendon disease/disorder

- Known history of liver dysfunction, including known elevated transaminases (ALT

and/or AST >3 times the upper limit of normal)

- Known severe renal impairment with glomerular filtration rate of <30mL/min

- Known neutropenia (neutrophil count <1000/mm3) caused by immunosuppressive therapy or

malignancy

- Known to have AIDS (CD4 count of <200/mm3), or be HIV positive and receiving Highly

Active Anti Retroviral Therapy (HAART) (HIV testing is not mandatory)

- Known bronchial carcinoma, active pulmonary tuberculosis, known diffuse

bronchiectasis, cystic fibrosis, chronic asthma (>15% reversibility), or pneumonia (a chest X ray is not mandatory)

- Known history of chronic colonization of pathogenic organisms resistant to

moxifloxacin and/or amoxicillin clavulanic acid (e. g., Pseudomonas aeruginosa, MRSA)

- Receiving long term (>4 consecutive weeks) systemic corticosteroid treatment (>10

mg/day of prednisolone or equivalent)

- Received short course of systemic corticosteroid treatment within 30 days prior to

enrollment

- Requiring intravenous antibiotic therapy for treatment of the current exacerbation

- Unable to take oral medication

- Life expectancy of less than 6 months

- Receiving systemic antibacterial therapy within 30 days prior to study enrollment

- Requiring concomitant systemic antibacterial agents

- Use of any investigational drug or device within 30 days of screening, or previously

enrolled in this study

- Requiring home ventilatory support (subjects requiring home/portable oxygen therapy

or CPAP for sleep apnea are not excluded) and/or those who have a tracheotomy in situ

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Escaldes - Engordany, Andorra; Recruiting

YVOIR 5530, Belgium; Not yet recruiting

AALST 9300, Belgium; Recruiting

ANTWERPEN 2018, Belgium; Not yet recruiting

NAMUR 5000, Belgium; Recruiting

BRUXELLES - BRUSSEL 1020, Belgium; Not yet recruiting

Valparaiso 236-3058, Chile; Recruiting

Santiago, Chile; Recruiting

Viña del Mar, Chile; Recruiting

Santiago, Chile; Not yet recruiting

Shanghai 200233, China; Recruiting

Shanghai 200003, China; Recruiting

Shanghai 200040, China; Recruiting

Tianjin 300052, China; Recruiting

beijing 100020, China; Recruiting

Beijing 100050, China; Recruiting

Bogotá, Colombia; Recruiting

Bogotá, Colombia; Not yet recruiting

Medellín, Colombia; Not yet recruiting

Cali, Colombia; Recruiting

Bucaramanga, Colombia; Not yet recruiting

Medellín, Colombia; Recruiting

Zagreb 10000, Croatia; Not yet recruiting

Rijeka 510 00, Croatia; Not yet recruiting

Petrinja 44 250, Croatia; Not yet recruiting

Osijek 310 00, Croatia; Not yet recruiting

Praha - Malesice 108 00, Czech Republic; Not yet recruiting

Neratovice 227 11, Czech Republic; Not yet recruiting

Lovosice 410 02, Czech Republic; Not yet recruiting

Kyjov 697 01, Czech Republic; Not yet recruiting

Praha - Troja 182 00, Czech Republic; Not yet recruiting

Pardubice - Trnova 530 09, Czech Republic; Not yet recruiting

PERPIGNAN 66025, France; Terminated

NICE 06000, France; Terminated

MARSEILLE 13009, France; Terminated

MONT-DE-MARSAN 40000, France; Terminated

Berlin 10717, Germany; Recruiting

Berlin 12043, Germany; Terminated

Berlin 12203, Germany; Recruiting

Berlin 10969, Germany; Recruiting

Berlin 14059, Germany; Recruiting

Berlin 13597, Germany; Not yet recruiting

Hamburg 20354, Germany; Recruiting

Athens 11527, Greece; Recruiting

New Territories, Hong Kong; Recruiting

Kowloon, Hong Kong; Recruiting

Jakarta, Indonesia; Recruiting

Bandung, Indonesia; Recruiting

Surabaya, Indonesia; Recruiting

Chieti 66100, Italy; Recruiting

Milano 20157, Italy; Not yet recruiting

Ancona 60100, Italy; Recruiting

Perugia 06156, Italy; Terminated

Catania 95123, Italy; Not yet recruiting

Riga 1011, Latvia; Not yet recruiting

Riga 1009, Latvia; Terminated

Valmiera 4201, Latvia; Not yet recruiting

Ventspils, Latvia; Recruiting

Vilnius LT-07156, Lithuania; Not yet recruiting

Vilnius LT-06122, Lithuania; Recruiting

Kaunas LT-50425, Lithuania; Recruiting

Kaunas, Lithuania; Recruiting

Klaipeda LT-94231, Lithuania; Recruiting

Siauliai 76231, Lithuania; Not yet recruiting

Chihuahua 31350, Mexico; Not yet recruiting

Zacatecas 98608, Mexico; Not yet recruiting

HEERLEN 6419 PC, Netherlands; Recruiting

HOOFDDORP 2134 TM, Netherlands; Not yet recruiting

MEPPEL 7943 KA, Netherlands; Not yet recruiting

UTRECHT 3582 KE, Netherlands; Not yet recruiting

Karachi 75500, Pakistan; Recruiting

Islamabad, Pakistan; Terminated

Lima 33, Peru; Recruiting

Callao CALLAO 2, Peru; Not yet recruiting

Lima, Peru; Recruiting

Lima LIMA 27, Peru; Recruiting

Lima 31, Peru; Not yet recruiting

Lima LIMA 18, Peru; Not yet recruiting

Manila 1000, Philippines; Recruiting

Quezon City, Philippines; Recruiting

Lisboa 1169-024, Portugal; Not yet recruiting

Vila Nova de Gaia 4434-506, Portugal; Not yet recruiting

Lisboa 1649-035, Portugal; Terminated

Coimbra 3000-075, Portugal; Terminated

Santarém 2005-177, Portugal; Not yet recruiting

Torres Vedras 2560-324, Portugal; Not yet recruiting

Barcelona 08034, Spain; Not yet recruiting

Barcelona 08036, Spain; Not yet recruiting

Guadalajara 19002, Spain; Terminated

Madrid 28040, Spain; Not yet recruiting

Palma de Mallorca 07014, Spain; Recruiting

Wettingen 5430, Switzerland; Not yet recruiting

Thun 3600, Switzerland; Not yet recruiting

Basel 4031, Switzerland; Recruiting

Zürich 8048, Switzerland; Not yet recruiting

Zürich 8091, Switzerland; Not yet recruiting

Nonthaburi 11000, Thailand; Recruiting

Chiangmai 50200, Thailand; Recruiting

Bangkok 10330, Thailand; Recruiting

Aarau, Aargau 5000, Switzerland; Not yet recruiting

Calgary, Alberta T2N 4N1, Canada; Recruiting

Edmonton, Alberta T6G 2B7, Canada; Recruiting

Edmonton, Alberta T6L 5X8, Canada; Recruiting

Athens, Attica 106 76, Greece; Recruiting

Bad Dürrheim, Baden-Württemberg 78073, Germany; Recruiting

Badalona, Barcelona 08916, Spain; Recruiting

Sant Boi de Llobregat, Barcelona 08830, Spain; Not yet recruiting

Oberwil, Basel-Land 4104, Switzerland; Terminated

Laufen, Basel-Landschaft 4242, Switzerland; Terminated

Binningen, Basel-Stadt 4102, Switzerland; Terminated

Augsburg, Bayern 86150, Germany; Terminated

Rüdersdorf, Brandenburg 15562, Germany; Not yet recruiting

Cottbus, Brandenburg 03050, Germany; Recruiting

Zossen, Brandenburg 15806, Germany; Recruiting

Kelowna, British Columbia V1Y 9L8, Canada; Recruiting

Vancouver, British Columbia V5Z 4E1, Canada; Recruiting

Vicente López, Buenos Aires B1602DOH, Argentina; Recruiting

Quilmes, Buenos Aires, Argentina; Recruiting

Florencio Varela, Buenos aires, Argentina; Recruiting

Buenos Aires, Capital Federal C1425AWC, Argentina; Recruiting

Buenos Aires, Capital Federal, Argentina; Terminated

Buenos Aires, Capital Federal 1426, Argentina; Recruiting

Buenos Aires, Capital Federal, Argentina; Recruiting

Killarney, Co Kerry, Ireland; Not yet recruiting

Longford, Co Longford, Ireland; Not yet recruiting

Gorey, Co Wexford, Ireland; Terminated

Enniscorthy, Co Wexford, Ireland; Recruiting

Gorey, Co Wexford, Ireland; Not yet recruiting

S. Martinho do Bispo, Coimbra 3041-856, Portugal; Not yet recruiting

Rathmines, Dublin, Ireland; Not yet recruiting

Huixquilucan, Edo. de Mexico CP 52763, Mexico; Not yet recruiting

Bloemfontein, Free State 9324, South Africa; Recruiting

Benoni, Gauteng 1500, South Africa; Recruiting

Kempton Park, Gauteng 1610, South Africa; Recruiting

Centurion, Gauteng 0140, South Africa; Recruiting

Pretoria, Gauteng, South Africa; Recruiting

Guangzhou, Guangdong 510120, China; Recruiting

Fulda, Hessen 36039, Germany; Recruiting

Frankfurt, Hessen 60318, Germany; Terminated

Dourouti-Ioannina, Ioannina 45500, Greece; Recruiting

Guadalajara, Jalisco 44280, Mexico; Recruiting

Durban, KwaZulu Natal 4091, South Africa; Recruiting

Durban, KwaZulu Natal 4037, South Africa; Not yet recruiting

Mezourlo, Larissa 41110, Greece; Recruiting

Shenyang, Liaoning 11000, China; Recruiting

Shenyang, Liaoning 110003, China; Recruiting

Thabazimbi, Limpopo 0380, South Africa; Not yet recruiting

Winnipeg, Manitoba R3C 0N2, Canada; Recruiting

Winnipeg, Manitoba R3A 1R9, Canada; Terminated

Neubrandenburg, Mecklenburg-Vorpommern 17033, Germany; Terminated

Witbank, Mpumalanga 1035, South Africa; Recruiting

St. John, New Brunswick E2M 3W5, Canada; Terminated

St. John, New Brunswick E2K 2T8, Canada; Not yet recruiting

Sydney, New South Wales 2139, Australia; Not yet recruiting

EINDHOVEN, Noord Brabant 5623 EJ, Netherlands; Recruiting

Lüdenscheid, Nordrhein-Westfalen 58515, Germany; Recruiting

Antigonish, Nova Scotia B2G 2C2, Canada; Recruiting

Sydney Mines, Nova Scotia B1V 2Y5, Canada; Recruiting

Monterrey, Nuevo León 66480, Mexico; Not yet recruiting

Monterrey, Nuevo León 64718, Mexico; Not yet recruiting

London, Ontario N6A 4V2, Canada; Not yet recruiting

Hamilton, Ontario L8N 4A6, Canada; Not yet recruiting

Toronto, Ontario M6H 3M2, Canada; Not yet recruiting

London, Ontario N6A 5R9, Canada; Not yet recruiting

Burlington, Ontario L7R 2H3, Canada; Not yet recruiting

Rio, Patras 265 04, Greece; Recruiting

Korsten, Port Elizabert 6014, South Africa; Not yet recruiting

Eloffsdal, Pretoria 0084, South Africa; Recruiting

Sunnyside, Pretoria 0002, South Africa; Not yet recruiting

Montreal, Quebec H2L 4M1, Canada; Recruiting

Sherbrooke, Quebec JIH 4J6, Canada; Not yet recruiting

Longueuil, Quebec J4N 1E1, Canada; Terminated

Brisbane, Queensland 4101, Australia; Recruiting

Porto Alegre, RS 90610-000, Brazil; Recruiting

Neuwied, Rheinland-Pfalz 56564, Germany; Not yet recruiting

Sao Paulo, SP 04023-900, Brazil; Recruiting

Sao Paulo, SP 05403-900, Brazil; Not yet recruiting

Leipzig, Sachsen 04275, Germany; Terminated

Dresden, Sachsen 01307, Germany; Not yet recruiting

Leipzig, Sachsen 04357, Germany; Recruiting

Leipzig, Sachsen 04207, Germany; Not yet recruiting

Delitzsch, Sachsen 04509, Germany; Not yet recruiting

Nocera Inferiore, Salerno 84014, Italy; Recruiting

Bad Segeberg, Schleswig-Holstein 23795, Germany; Recruiting

Lübeck, Schleswig-Holstein 23552, Germany; Recruiting

Chengdu, Sichuan 610041, China; Recruiting

Karachi, Sindh 74800, Pakistan; Terminated

Adelaide, South Australia 5011, Australia; Recruiting

Adelaide, South Australia 5041, Australia; Recruiting

Glasgow, Strathclyde G69 7AD, United Kingdom; Recruiting

Glasgow, Strathclyde G3 8YJ, United Kingdom; Terminated

Glasgow, Strathclyde, United Kingdom; Terminated

Glasgow, Strathclyde G46 8NY, United Kingdom; Recruiting

Glasgow, Strathclyde G45 9AW, United Kingdom; Not yet recruiting

San Miguel de Tucumán, Tucumán 4000, Argentina; Recruiting

San Miguel de Tucumán, Tucumán, Argentina; Recruiting

Viña del Mar, V Region, Chile; Not yet recruiting

Requena, Valencia 46340, Spain; Recruiting

Cali, Valle del Cauca, Colombia; Not yet recruiting

Busto Arsizio, Varese 21052, Italy; Recruiting

Bussolengo, Verona 37012, Italy; Not yet recruiting

Coventry, Warwickshire CV7 8LA, United Kingdom; Terminated

Perth, Western Australia 6009, Australia; Recruiting

Paarl, Western Cape 7647, South Africa; Recruiting

Cape Town, Western Cape 7505, South Africa; Recruiting

Somerset West, Western Cape 7130, South Africa; Recruiting

Bray, Wicklow, Ireland; Not yet recruiting

Mérida, Yucatán 97001, Mexico; Not yet recruiting

Mérida, Yucatán 97001, Mexico; Recruiting

Juiz de Fora, mg 36036-110, Brazil; Recruiting

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Starting date: March 2008
Ending date: June 2010
Last updated: September 30, 2009