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Pulmonary Disease, Chronic ObstructivePhase 2NCT01543919

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

A Phase 2 study testing PH-797804 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 132 sites in 14 countries.

Completed

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

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
PH-797804
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
730 participants
Where
132 sitesin 14 countries
Study dates
Apr 2012to Sep 2013
Phase
Phase 2
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 21Show fewer
  • 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.

Trial locations and contacts

132 sites in 14 countries.

132 sites in 14 countries

United States45 sites

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87108

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87109

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87110

  • Pfizer Investigational Site

    Baltimore, Maryland, 21224

  • Pfizer Investigational Site

    Birmingham, Alabama, 35205

  • Pfizer Investigational Site

    Birmingham, Alabama, 35233

  • Pfizer Investigational Site

    Birmingham, Alabama, 35294

  • Pfizer Investigational Site

    Brandon, Florida, 33511

  • Pfizer Investigational Site

    Charleston, South Carolina, 29407

  • Pfizer Investigational Site

    Charleston, South Carolina, 29414

  • Pfizer Investigational Site

    Charlotte, North Carolina, 28207

  • Pfizer Investigational Site

    Chiefland, Florida, 32226

  • Pfizer Investigational Site

    Chiefland, Florida, 32626

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45231

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45242

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45245

  • Pfizer Investigational Site

    Clearwater, Florida, 33756

  • Pfizer Investigational Site

    Clearwater, Florida, 33765

  • Pfizer Investigational Site

    Duluth, Georgia, 30096

  • Pfizer Investigational Site

    Edina, Minnesota, 55435

  • Pfizer Investigational Site

    Fort Mitchell, Kentucky, 41017

  • Pfizer Investigational Site

    Fridley, Minnesota, 55432

  • Pfizer Investigational Site

    Houston, Texas, 77030

  • Pfizer Investigational Site

    Jasper, Alabama, 35501

  • Pfizer Investigational Site

    Kingsport, Tennessee, 37660

  • Pfizer Investigational Site

    Lexington, Kentucky, 40504

  • Pfizer Investigational Site

    Midvale, Utah, 84047

  • Pfizer Investigational Site

    Minneapolis, Minnesota, 55407

  • Pfizer Investigational Site

    Montclair, California, 91763

  • Pfizer Investigational Site

    New Port Richey, Florida, 34653

  • Pfizer Investigational Site

    Newark, Delaware, 19713

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73112

  • Pfizer Investigational Site

    Pawtucket, Rhode Island, 02860

  • Pfizer Investigational Site

    Pensacola, Florida, 32504

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19140

  • Pfizer Investigational Site

    Phoenix, Arizona, 85006

  • Pfizer Investigational Site

    Rochester, Minnesota, 55905

  • Pfizer Investigational Site

    Rochester, New York, 14618

  • Pfizer Investigational Site

    San Antonio, Texas, 78212

  • Pfizer Investigational Site

    San Diego, California, 92120

  • Pfizer Investigational Site

    St Louis, Missouri, 63141

  • Pfizer Investigational Site

    Tampa, Florida, 33603

  • Pfizer Investigational Site

    Warwick, Rhode Island, 02886

  • Pfizer Investigational Site

    Waterbury, Connecticut, 06708

  • Pfizer Investigational Site

    Williston, Florida, 32696

Other trials in United States

Japan15 sites

  • Pfizer Investigational Site

    Fukuoka, Fukuoka

  • Pfizer Investigational Site

    Kanazawa, Ishikawa-ken

  • Pfizer Investigational Site

    Kawasaki-shi, Kanagawa

  • Pfizer Investigational Site

    Kumamoto, Kumamoto

  • Pfizer Investigational Site

    Meguro-ku, Tokyo

  • Pfizer Investigational Site

    Nagoya, Aichi-ken

  • Pfizer Investigational Site

    Noda, Chiba

  • Pfizer Investigational Site

    Osaka, Osaka

  • Pfizer Investigational Site

    Saiki, Oita Prefecture

  • Pfizer Investigational Site

    Setagaya City, Tokyo

  • Pfizer Investigational Site

    Seto-shi, Aichi-ken

  • Pfizer Investigational Site

    Takamatsu, Kagawa-ken

  • Pfizer Investigational Site

    Toyota, Aichi-ken

  • Pfizer Investigational Site

    Yanagawa, Fukuoka

  • Pfizer Investigational Site

    Zama, Kanagawa

Other trials in Japan

Germany11 sites

  • Pfizer Investigational Site

    Berlin, 10117

  • Pfizer Investigational Site

    Berlin, 13125

  • Pfizer Investigational Site

    Dresden, 01069

  • Pfizer Investigational Site

    Gelnhausen, 63571

  • Pfizer Investigational Site

    Großhansdorf, 22927

  • Pfizer Investigational Site

    Hamburg, 20253

  • Pfizer Investigational Site

    Hamburg, 20354

  • Pfizer Investigational Site

    Hanover, 30159

  • Pfizer Investigational Site

    Kassel, 34121

  • Pfizer Investigational Site

    Lübeck, 23552

  • Pfizer Investigational Site

    Schwerin, 19055

Other trials in Germany

Slovakia11 sites

  • Pfizer Investigational Site

    Bardejov, 085 01

  • Pfizer Investigational Site

    Bojnice, 972 01

  • Pfizer Investigational Site

    Bratislava, 826 06

  • Pfizer Investigational Site

    Bratislava, 841 04

  • Pfizer Investigational Site

    Humenné, 066 01

  • Pfizer Investigational Site

    Košice, 040 01

  • Pfizer Investigational Site

    Liptovský Hrádok, 033 01

  • Pfizer Investigational Site

    Námestovo, 029 01

  • Pfizer Investigational Site

    Poprad, 058 01

  • Pfizer Investigational Site

    Spišská Nová Ves, 052 01

  • Pfizer Investigational Site

    Štúrovo, 943 01

Other trials in Slovakia

South Africa8 sites

  • Pfizer Investigational Site

    Bloemfontein, Free State, 9301

  • Pfizer Investigational Site

    Cape Town, 7500

  • Pfizer Investigational Site

    Cape Town, 7530

  • Pfizer Investigational Site

    Durban, 4001

  • Pfizer Investigational Site

    Durban, 4126

  • Pfizer Investigational Site

    Gatesville, Western Cape, 7764

  • Pfizer Investigational Site

    Parow, Western Cape, 7505

  • Pfizer Investigational Site

    Pretoria, 0181

Other trials in South Africa

Bulgaria7 sites

  • Pfizer Investigational Site

    Rousse, 7002

  • Pfizer Investigational Site

    Sevlievo, 5400

  • Pfizer Investigational Site

    Sofia, 1000

  • Pfizer Investigational Site

    Sofia, 1431

  • Pfizer Investigational Site

    Stara Zagora, 6003

  • Pfizer Investigational Site

    Troyan Municipality, 5600

  • Pfizer Investigational Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Canada7 sites

  • Pfizer Investigational Site

    Montreal, Quebec, H4N 3C5

  • Pfizer Investigational Site

    Québec, Quebec, G3K 2P8

  • Pfizer Investigational Site

    Saint Romuald, Quebec, G6W 5M6

  • Pfizer Investigational Site

    Sherbrooke, Quebec, J1H 1Z1

  • Pfizer Investigational Site

    Toronto, Ontario, M5T 3A9

  • Pfizer Investigational Site

    Toronto, Ontario, M6H 3M2

  • Pfizer Investigational Site

    Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

Czechia7 sites

  • Pfizer Investigational Site

    Karlovy Vary, 36009

  • Pfizer Investigational Site

    Liberec, 460 01

  • Pfizer Investigational Site

    Mělník, 27601

  • Pfizer Investigational Site

    Prague, 108 00

  • Pfizer Investigational Site

    Prague, 153 00

  • Pfizer Investigational Site

    Rokycany, 337 22

  • Pfizer Investigational Site

    Teplice, 41501

Other trials in Czechia

Hungary7 sites

  • Pfizer Investigational Site

    Balassagyarmat, 2660

  • Pfizer Investigational Site

    Budaörs, 2040

  • Pfizer Investigational Site

    Budapest, 1122

  • Pfizer Investigational Site

    Debrecen, 4032

  • Pfizer Investigational Site

    Szeged, 6722

  • Pfizer Investigational Site

    Szombathely, 9700

  • Pfizer Investigational Site

    Törökbálint, 2045

Other trials in Hungary

Sweden5 sites

  • Pfizer Investigational Site

    Gothenburg, 412 63

  • Pfizer Investigational Site

    Linköping, 58216

  • Pfizer Investigational Site

    Lund, 22185

  • Pfizer Investigational Site

    Malmö, 211 52

  • Pfizer Investigational Site

    Skene, 511 62

Other trials in Sweden

Spain4 sites

  • Pfizer Investigational Site

    Mérida, Badajoz, 06800

  • Pfizer Investigational Site

    Petrel, Alicante, 03610

  • Pfizer Investigational Site

    Pozuelo de Alarcón, Madrid, 28223

  • Pfizer Investigational Site

    Salt, Girona, 17190

Other trials in Spain

Poland3 sites

  • Pfizer Investigational Site

    Warsaw, 04-141

  • Pfizer Investigational Site

    Wroclaw, 53-301

  • Pfizer Investigational Site

    Wroclaw, 54-239

Other trials in Poland

Argentina1 site

  • Pfizer Investigational Site

    Buenos Aires, 1426

Other trials in Argentina

Taiwan1 site

  • Pfizer Investigational Site

    Taipei, 100

Other trials in Taiwan

About this study

Official title: 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)

Being tested
PH-797804, Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • PH-797804Drug

    0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

  • PH-797804Drug

    1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

  • PH-797804Drug

    3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

  • PH-797804Drug

    6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

  • PH-797804Drug

    10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

  • PlaceboDrug

    Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

Study groups in NCT01543919
Study groupRoleWhat they receive
PH-787904 (arm1)ExperimentalNot described
Receives: Drug: PH-797804
PH-787904 (arm2)ExperimentalNot described
Receives: Drug: PH-797804
PH-787904 (arm3)ExperimentalNot described
Receives: Drug: PH-797804
PH-787904 (arm4)ExperimentalNot described
Receives: Drug: PH-797804
PH-787904 (arm5)ExperimentalNot described
Receives: Drug: PH-797804
PlaceboExperimentalNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change from baseline in trough (pre-treatment and pre-bronchodilator) Forced Expiratory Volume1 at Week 12.

    Measured: Baseline, week 12

Secondary outcomes (13)

  1. Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume1 at Weeks 2, 6, and 10

    Measured: Baseline, week 2, 6, and 10

  2. Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume6 at Weeks 2, 6, 10 and 12

    Measured: Baseline, week 2, 6, 10 and 12

  3. Change from baseline in trough, pre-bronchodilator Forced Vital Capacity at Weeks 2, 6, 10 and 12

    Measured: Baseline, week 2, 6, 10 and 12

  4. Change from baseline in trough, pre-bronchodilator Inspiratory Capacity at Weeks 2, 6, 10 and 12

    Measured: Baseline, week 2, 6, 10 and 12

  5. 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

    Measured: Baseline, week 12

  6. 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

    Measured: Baseline, week 0, 12

  7. 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

    Measured: Baseline, week 0, week 12

  8. Change from baseline in Chronic Obstructive Pulmonary Disease symptoms (EXACT-PRO Daily Diary) over 12 weeks treatment.

    Measured: Baseline, week 12

  9. Change from baseline in Chronic Respiratory Questionnaire - Self Administered Standard (CRQ-SAS) at Weeks 2, 6, 10 and 12

    Measured: Baseline, week 2, 4, 6, 10 and 12

  10. Patient Global Impression of Change at Week 12

    Measured: Baseline, week 12

  11. Change from baseline (Baseline Dyspnea Index) in dyspnea (Transition Dyspnea Index) at Weeks 2, 6, 10 and 12

    Measured: Baseline, week 2, 4, 6, 10, and 12

  12. Clinician Global Impression of Change at Week 12

    Measured: Baseline, week 12

  13. Rescue bronchodilator use (per daily diary) over 12 weeks of therapy

    Measured: Baseline, week 12

Timeline

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

  1. First posted5 Mar 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionSep 2013
  4. Study completionSep 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
730 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01543919
Sponsor's protocol ID
A6631033
Status last verified
Sep 2014
First submitted
28 Feb 2012
Last updated
27 Oct 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PH-797804 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 132 sites in 14 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 5 inclusion and 21 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 27 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 132 sites in United States, Japan, Germany, Slovakia, South Africa and 9 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change from baseline in trough (pre-treatment and pre-bronchodilator) Forced Expiratory Volume1 at Week 12. (time frame: Baseline, week 12). 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 NCT01543919.

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 27 Oct 2014.

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