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

October 15, 2014 updated by: Pfizer

A Phase 2B, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide

PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
730

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Pfizer Investigational Site
  • Bulgaria
      • Ruse, Bulgaria, 7002
        • Pfizer Investigational Site
      • Sevlievo, Bulgaria, 5400
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1431
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1000
        • Pfizer Investigational Site
      • Stara Zagora, Bulgaria, 6003
        • Pfizer Investigational Site
      • Troyan, Bulgaria, 5600
        • Pfizer Investigational Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G3K 2P8
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2K 3S8
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M2
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5T 3A9
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4N 3C5
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • Pfizer Investigational Site
      • St-Romuald, Quebec, Canada, G6W 5M6
        • Pfizer Investigational Site
  • Czech Republic
      • Karlovy Vary, Czech Republic, 36009
        • Pfizer Investigational Site
      • Liberec, Czech Republic, 460 01
        • Pfizer Investigational Site
      • Melnik, Czech Republic, 27601
        • Pfizer Investigational Site
      • Praha 10, Czech Republic, 108 00
        • Pfizer Investigational Site
      • Praha 5, Czech Republic, 153 00
        • Pfizer Investigational Site
      • Rokycany, Czech Republic, 337 22
        • Pfizer Investigational Site
      • Teplice, Czech Republic, 41501
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Berlin, Germany, 13125
        • Pfizer Investigational Site
      • Dresden, Germany, 01069
        • Pfizer Investigational Site
      • Gelnhausen, Germany, 63571
        • Pfizer Investigational Site
      • Grosshansdorf, Germany, 22927
        • Pfizer Investigational Site
      • Hamburg, Germany, 20253
        • Pfizer Investigational Site
      • Hamburg, Germany, 20354
        • Pfizer Investigational Site
      • Hannover, Germany, 30159
        • Pfizer Investigational Site
      • Kassel, Germany, 34121
        • Pfizer Investigational Site
      • Luebeck, Germany, 23552
        • Pfizer Investigational Site
      • Schwerin, Germany, 19055
        • Pfizer Investigational Site
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Pfizer Investigational Site
      • Budaors, Hungary, 2040
        • Pfizer Investigational Site
      • Budapest, Hungary, 1122
        • Pfizer Investigational Site
      • Debrecen, Hungary, 4032
        • Pfizer Investigational Site
      • Szeged, Hungary, 6722
        • Pfizer Investigational Site
      • Szombathely, Hungary, 9700
        • Pfizer Investigational Site
      • Torokbalint, Hungary, 2045
        • Pfizer Investigational Site
  • Japan
      • Fukuoka, Japan
        • Pfizer Investigational Site
      • Kumamoto, Japan
        • Pfizer Investigational Site
      • Osaka, Japan
        • Pfizer Investigational Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Pfizer Investigational Site
      • Toyota, Aichi, Japan
        • Pfizer Investigational Site
    • Aichi-ken
      • Seto-shi, Aichi-ken, Japan
        • Pfizer Investigational Site
    • Chiba
      • Noda, Chiba, Japan
        • Pfizer Investigational Site
    • Fukuoka
      • Yanagawa, Fukuoka, Japan
        • Pfizer Investigational Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
        • Pfizer Investigational Site
    • Kagawa
      • Takamatsu, Kagawa, Japan
        • Pfizer Investigational Site
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan
        • Pfizer Investigational Site
      • Zama, Kanagawa, Japan
        • Pfizer Investigational Site
    • Oita
      • Saiki, Oita, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Meguro-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Setagaya, Tokyo, Japan
        • Pfizer Investigational Site
  • Poland
      • Warszawa, Poland, 04-141
        • Pfizer Investigational Site
      • Wroclaw, Poland, 53-301
        • Pfizer Investigational Site
      • Wroclaw, Poland, 54-239
        • Pfizer Investigational Site
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Pfizer Investigational Site
      • Bojnice, Slovakia, 972 01
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 826 06
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 841 04
        • Pfizer Investigational Site
      • Humenne, Slovakia, 066 01
        • Pfizer Investigational Site
      • Kosice, Slovakia, 040 01
        • Pfizer Investigational Site
      • Liptovsky Hradok, Slovakia, 033 01
        • Pfizer Investigational Site
      • Namestovo, Slovakia, 029 01
        • Pfizer Investigational Site
      • Poprad, Slovakia, 058 01
        • Pfizer Investigational Site
      • Spisska Nova Ves, Slovakia, 052 01
        • Pfizer Investigational Site
      • Sturovo, Slovakia, 943 01
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa, 7500
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7530
        • Pfizer Investigational Site
      • Durban, South Africa, 4001
        • Pfizer Investigational Site
      • Durban, South Africa, 4126
        • Pfizer Investigational Site
      • Pretoria, South Africa, 0181
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Pfizer Investigational Site
    • Western Cape
      • Gatesville, Western Cape, South Africa, 7764
        • Pfizer Investigational Site
      • Parow, Western Cape, South Africa, 7505
        • Pfizer Investigational Site
  • Spain
    • Alicante
      • Petrer, Alicante, Spain, 03610
        • Pfizer Investigational Site
    • Badajoz
      • Merida, Badajoz, Spain, 06800
        • Pfizer Investigational Site
    • Girona
      • Salt, Girona, Spain, 17190
        • Pfizer Investigational Site
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 412 63
        • Pfizer Investigational Site
      • Linkoping, Sweden, 58216
        • Pfizer Investigational Site
      • Lund, Sweden, 22185
        • Pfizer Investigational Site
      • Malmo, Sweden, 211 52
        • Pfizer Investigational Site
      • Skene, Sweden, 511 62
        • Pfizer Investigational Site
  • Taiwan
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
      • Jasper, Alabama, United States, 35501
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pfizer Investigational Site
    • California
      • Montclair, California, United States, 91763
        • Pfizer Investigational Site
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Pfizer Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Pfizer Investigational Site
      • Chiefland, Florida, United States, 32626
        • Pfizer Investigational Site
      • Chiefland, Florida, United States, 32226
        • Pfizer Investigational Site
      • Clearwater, Florida, United States, 33756
        • Pfizer Investigational Site
      • Clearwater, Florida, United States, 33765
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States, 34653
        • Pfizer Investigational Site
      • Pensacola, Florida, United States, 32504
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33603
        • Pfizer Investigational Site
      • Williston, Florida, United States, 32696
        • Pfizer Investigational Site
    • Georgia
      • Duluth, Georgia, United States, 30096
        • Pfizer Investigational Site
    • Kentucky
      • Fort Mitchell, Kentucky, United States, 41017
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40504
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Pfizer Investigational Site
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Pfizer Investigational Site
      • Fridley, Minnesota, United States, 55432
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55407
        • Pfizer Investigational Site
      • Rochester, Minnesota, United States, 55905
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87108
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87110
        • Pfizer Investigational Site
    • New York
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45242
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45245
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Pfizer Investigational Site
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Pfizer Investigational Site
      • Warwick, Rhode Island, United States, 02886
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Pfizer Investigational Site
      • Charleston, South Carolina, United States, 29407
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78212
        • Pfizer Investigational Site
    • Utah
      • Midvale, Utah, United States, 84047
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects between, and including, the ages of 40 and 80 years.
  • 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:

  • A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Placebo
Drug: Placebo
Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
EXPERIMENTAL: PH-787904 (arm1)
Drug: PH-797804
0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
EXPERIMENTAL: PH-787904 (arm2)
Drug: PH-797804
0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
EXPERIMENTAL: PH-787904 (arm3)
Drug: PH-797804
0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
EXPERIMENTAL: PH-787904 (arm4)
Drug: PH-797804
0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
EXPERIMENTAL: PH-787904 (arm5)
Drug: PH-797804
0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
Drug: PH-797804
10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in trough (pre-treatment and pre-bronchodilator) Forced Expiratory Volume1 at Week 12.
Time Frame: Baseline, week 12
Baseline, week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume1 at Weeks 2, 6, and 10
Time Frame: Baseline, week 2, 6, and 10
Baseline, week 2, 6, and 10
Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume6 at Weeks 2, 6, 10 and 12
Time Frame: Baseline, week 2, 6, 10 and 12
Baseline, week 2, 6, 10 and 12
Change from baseline in trough, pre-bronchodilator Forced Vital Capacity at Weeks 2, 6, 10 and 12
Time Frame: Baseline, week 2, 6, 10 and 12
Baseline, week 2, 6, 10 and 12
Change from baseline in trough, pre-bronchodilator Inspiratory Capacity at Weeks 2, 6, 10 and 12
Time Frame: Baseline, week 2, 6, 10 and 12
Baseline, week 2, 6, 10 and 12
Average change from baseline in trough, pre-bronchodilator Forced Expiratory Volume 1, Forced Expiratory Volume 6, Forced Vital Capacity and Inspiratory Capacity over 12 weeks treatment
Time Frame: Baseline, week 12
Baseline, week 12
Change from baseline in post-study drug, pre-bronchodilator Forced Expiratory Volume1, Forced Expiratory Volume6, Forced Vital Capacity and Inspiratory Capacity at Weeks 0 and 12
Time Frame: Baseline, week 0, 12
Baseline, week 0, 12
Change from baseline in post-study drug, post-bronchodilator Forced Expiratory Volume1, Forced Expiratory Volume6, Forced Vital Capacity and Inspiratory Capacity at Weeks 0 and 12
Time Frame: Baseline, week 0, week 12
Baseline, week 0, week 12
Change from baseline in Chronic Obstructive Pulmonary Disease symptoms (EXACT-PRO Daily Diary) over 12 weeks treatment.
Time Frame: Baseline, week 12
Baseline, week 12
Change from baseline in Chronic Respiratory Questionnaire - Self Administered Standard (CRQ-SAS) at Weeks 2, 6, 10 and 12
Time Frame: Baseline, week 2, 4, 6, 10 and 12
Baseline, week 2, 4, 6, 10 and 12
Patient Global Impression of Change at Week 12
Time Frame: Baseline, week 12
Baseline, week 12
Change from baseline (Baseline Dyspnea Index) in dyspnea (Transition Dyspnea Index) at Weeks 2, 6, 10 and 12
Time Frame: Baseline, week 2, 4, 6, 10, and 12
Baseline, week 2, 4, 6, 10, and 12
Clinician Global Impression of Change at Week 12
Time Frame: Baseline, week 12
Baseline, week 12
Rescue bronchodilator use (per daily diary) over 12 weeks of therapy
Time Frame: Baseline, week 12
Baseline, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A6631033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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