Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide
NCT ID: NCT01543919
Last Updated: 2014-10-27
Study Results
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Basic Information
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COMPLETED
PHASE2
730 participants
INTERVENTIONAL
2012-04-30
2013-09-30
Brief Summary
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A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PH-787904 (arm1)
PH-797804
0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
PH-787904 (arm2)
PH-797804
1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
PH-787904 (arm3)
PH-797804
3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
PH-787904 (arm4)
PH-797804
6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
PH-787904 (arm5)
PH-797804
10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Placebo
Placebo
Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Interventions
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PH-797804
0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
PH-797804
1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
PH-797804
3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
PH-797804
6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
PH-797804
10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Placebo
Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease: Subjects must have a post-bronchodilator FEV1/FVC ratio \<0.7 and a post-bronchodilator FEV1 of 30 - 80% (inclusive) of the predicted value for age, height, race and sex using European Community for Coal and Steel ECCS standards or NHANES III standards.
* Subjects must have a smoking history of at least 10 pack-years\* and meet one of the following criteria: They are current smokers, or they are ex-smokers who have abstained from smoking for at least 6 months.
* Subjects treated with tiotropium bromide (SPIRIVA HandiHaler) 18 microgram daily for at least 1 month prior to screening.
* Subjects must have had stable disease for at least 1 month prior to screening. During the screening and run-in phase subjects must be able to manage disease symptoms adequately with tiotropium bromide +/- salbutamol (albuterol) rescue medication (subjects should not use \>10 actuations \[100 microgram/actuations\] daily for more than 2 consecutive days), without reliance on other therapies including oral or inhaled corticosteroids, other long-acting bronchodilators, nebulizer therapy, theophylline, roflumilast or regular oxygen.
Exclusion Criteria
* History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomization.
* History or presence of respiratory failure, cor pulmonale or right ventricular failure.
* Subjects with home oxygen therapy (either PRN or long-term oxygen therapy).
* Any clearly documented history of adult asthma or other chronic respiratory disorders (eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis).
* Known previous diagnosis of Hepatitis B or C or HIV infection (specific screening is not required).
* History of cancer (other than cutaneous basal cell) in the previous 5 years.
* Active or past history of GI hemorrhage of any etiology, peptic ulceration, erosive esophagitis, gastric outlet obstruction or inflammatory bowel disease.
* Regular use of aspirin at a dose greater than 325 mg/day.
* History within the previous 6 months of: myocardial infarction, cardiac arrhythmia (eg, atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
* A family history of long QT syndrome.
* Presenting with: Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
* Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0.
* Any clinically significant active systemic or cutaneous infection including herpetic lesions.
* Congestive heart failure requiring treatment New York Heart Association (NYHA) Class III-IV.
* ECG abnormalities at screening or randomization, including those listed below: Subjects with pre-randomization evidence of QTcF prolongation (defined as \>450 ms) at screening or baseline (Week 0) are not eligible for randomization. This assessment is based on a confirmed mean of the triplicate ECG recordings and is made by the investigator at the time of ECG collection.
* Predominant heart rhythm other than normal sinus rhythm eg, atrial fibrillation, atrial flutter, supraventricular tachycardia.
* Atrioventricular (AV) block greater than first degree.
* Resting heart rate \>100 or \<40 bpm.
* Evidence of previous myocardial infarction in the absence of clinical history consistent with these findings.
* Evidence of acute ischemia.
40 Years
80 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Jasper, Alabama, United States
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Phoenix, Arizona, United States
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Montclair, California, United States
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San Diego, California, United States
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Waterbury, Connecticut, United States
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Newark, Delaware, United States
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Brandon, Florida, United States
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Chiefland, Florida, United States
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Chiefland, Florida, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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New Port Richey, Florida, United States
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Pensacola, Florida, United States
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Tampa, Florida, United States
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Williston, Florida, United States
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Duluth, Georgia, United States
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Fort Mitchell, Kentucky, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Edina, Minnesota, United States
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Fridley, Minnesota, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Pawtucket, Rhode Island, United States
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Warwick, Rhode Island, United States
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Charleston, South Carolina, United States
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Charleston, South Carolina, United States
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Kingsport, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Midvale, Utah, United States
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Buenos Aires, , Argentina
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Rousse, , Bulgaria
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Sevlievo, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Troyan Municipality, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Winnipeg, Manitoba, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint Romuald, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Karlovy Vary, , Czechia
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Liberec, , Czechia
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Mělník, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Rokycany, , Czechia
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Teplice, , Czechia
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Berlin, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Gelnhausen, , Germany
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Großhansdorf, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Kassel, , Germany
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Lübeck, , Germany
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Schwerin, , Germany
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Balassagyarmat, , Hungary
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Budaörs, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Szeged, , Hungary
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Szombathely, , Hungary
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Törökbálint, , Hungary
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Nagoya, Aichi-ken, Japan
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Seto-shi, Aichi-ken, Japan
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Toyota, Aichi-ken, Japan
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Noda, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Yanagawa, Fukuoka, Japan
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Kanazawa, Ishikawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Kawasaki-shi, Kanagawa, Japan
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Zama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Saiki, Oita Prefecture, Japan
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Osaka, Osaka, Japan
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Meguro-ku, Tokyo, Japan
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Setagaya City, Tokyo, Japan
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Bardejov, , Slovakia
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Bojnice, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Humenné, , Slovakia
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Košice, , Slovakia
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Liptovský Hrádok, , Slovakia
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Námestovo, , Slovakia
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Poprad, , Slovakia
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Spišská Nová Ves, , Slovakia
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Štúrovo, , Slovakia
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Bloemfontein, Free State, South Africa
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Gatesville, Western Cape, South Africa
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Parow, Western Cape, South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Pretoria, , South Africa
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Petrel, Alicante, Spain
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Mérida, Badajoz, Spain
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Salt, Girona, Spain
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Pozuelo de Alarcón, Madrid, Spain
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Gothenburg, , Sweden
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Linköping, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Skene, , Sweden
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Taipei, , Taiwan
Countries
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Related Links
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Other Identifiers
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A6631033
Identifier Type: -
Identifier Source: org_study_id
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