Chronic Obstructive Pulmonary DiseasePhase 2NCT00559910
A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
A Phase 2 study testing PH-797804 in people with Chronic Obstructive Pulmonary Disease, run by Pfizer at 45 sites in 13 countries.
Trial summary
PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- PH-797804
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 45 sitesin 13 countries
- Study dates
- Feb 2008to Dec 2009
- 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 had stable disease for at least 1 month prior to screening.
- Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up > 6 months ago.
Who cannot join
- More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
- History or presence of significant cardiovascular disease.
- ECG abnormalities.
- Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
- Evidence of organ or blood disorders.
Trial locations and contacts
45 sites in 13 countries.
45 sites in 13 countries
Czechia6 sites
Pfizer Investigational Site
Cvikov, 471 54
Pfizer Investigational Site
Kutná Hora, 283 01
Pfizer Investigational Site
Liberec, 460 01
Pfizer Investigational Site
Prague, 153 00
Pfizer Investigational Site
Strakonice, 387 01
Pfizer Investigational Site
Tábor, 39001
Argentina5 sites
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., C1425DQI
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., C1426ABP
Pfizer Investigational Site
Ciudad Autonoma de Buenos Aires (caba), Buenos Aires F.D., C1428DDE
Pfizer Investigational Site
La Plata, Buenos Aires, 1900
Pfizer Investigational Site
Rosario, Santa Fe Province, 2000
Canada5 sites
Pfizer Investigational Site
Hamilton, Ontario, L8N 3Z5
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7
Pfizer Investigational Site
Sainte-Foy, Quebec, G1V 4G5
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 4E1
Pfizer Investigational Site
Winnipeg, Manitoba, R2K 3S8
Hungary5 sites
Pfizer Investigational Site
Budapest, 1125
Pfizer Investigational Site
Budapest, H-1036
Pfizer Investigational Site
Deszk, 6772
Pfizer Investigational Site
Pécs, 7626
Pfizer Investigational Site
Szombathely, 9700
France4 sites
Pfizer Investigational Site
Lille, 59042 CEDEX
Pfizer Investigational Site
Marseille, 13009
Pfizer Investigational Site
Montpellier, 34295 CEDEX 5
Pfizer Investigational Site
Perpignan, 66000
Australia3 sites
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
Daw Park, South Australia, 5041
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Chile3 sites
Pfizer Investigational Site
Providencia, Santiago, RM, 7500691
Pfizer Investigational Site
Talca, 3460001
Pfizer Investigational Site
Valparaíso, Valparaiso, 2352499
Greece3 sites
Pfizer Investigational Site
Athens, 10676
Pfizer Investigational Site
Heraklion, 711 10
Pfizer Investigational Site
Larissa, 41 110
South Africa3 sites
Pfizer Investigational Site
Bloemfontein, 9301
Pfizer Investigational Site
Durban, KwaZulu-Natal, 4001
Pfizer Investigational Site
Durban, 4126
South Korea3 sites
Pfizer Investigational Site
Anyang, 431-070
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 138-736
Netherlands2 sites
Pfizer Investigational Site
Almere Stad, 1311 RL
Pfizer Investigational Site
Zutphen, 7207 BA
Russia2 sites
Pfizer Investigational Site
Yaroslavl, 150003
Pfizer Investigational Site
Yaroslavl, 150023
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- 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
PH-797804 at four dose levels
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PH-797804 | Experimental | PH-797804 at four dose levels Receives: Drug: PH-797804 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.
Measured: 6 weeks
Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.
Measured: 6 weeks
Secondary outcomes (8)
Peak expiratory flow rate.
Measured: 6 weeks
Blood sample for pharmacogenomics
Measured: 6 weeks
Blood sample for pharmacokinetics
Measured: 6 weeks
Rescue bronchodilator usage.
Measured: 6 weeks
Dyspnea index scores.
Measured: 6 weeks
Global impression of change (patient and clinician).
Measured: 6 weeks
Symptom scores.
Measured: 6 weeks
Blood sample for biomarkers
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559910
- Sponsor's protocol ID
- A6631011
- Status last verified
- Oct 2018
- First submitted
- 15 Nov 2007
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
MacNee W, Allan RJ, Jones I, De Salvo MC, Tan LF. Efficacy and safety of the oral p38 inhibitor PH-797804 in chronic obstructive pulmonary disease: a randomised clinical trial. Thorax. 2013 Aug;68(8):738-45. doi: 10.1136/thoraxjnl-2012-202744. Epub 2013 Mar 28.
PubMed 23539534
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT00559910
- Acronym / sponsor ID
- A6631011
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PH-797804 | Experimental | Drug: PH-797804PH-797804 at four dose levels |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 had stable disease for at least 1 month prior to screening.
- Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up > 6 months ago.
Key exclusion criteria (5 listed)
- More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
- History or presence of significant cardiovascular disease.
- ECG abnormalities.
- Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
- Evidence of organ or blood disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PH-797804PH-797804 at four dose levels | Drug | PH-797804 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.
Time frame: 6 weeks
Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.
Time frame: 6 weeks
8 secondary outcomes
Peak expiratory flow rate.
Time frame: 6 weeks
Blood sample for pharmacogenomics
Time frame: 6 weeks
Blood sample for pharmacokinetics
Time frame: 6 weeks
Rescue bronchodilator usage.
Time frame: 6 weeks
Dyspnea index scores.
Time frame: 6 weeks
Global impression of change (patient and clinician).
Time frame: 6 weeks
Symptom scores.
Time frame: 6 weeks
Blood sample for biomarkers
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Derived from this study: PubMed 23539534MacNee W, Allan RJ, Jones I, De Salvo MC, Tan LF. Efficacy and safety of the oral p38 inhibitor PH-797804 in chronic obstructive pulmonary disease: a randomised clinical trial. Thorax. 2013 Aug;68(8):738-45. doi: 10.1136/thoraxjnl-2012-202744. Epub 2013 Mar 28.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
45 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PH-797804 in people with Chronic Obstructive Pulmonary Disease, run by Pfizer at 45 sites in 13 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 3 inclusion and 5 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Czechia, Argentina, Canada, Hungary, France and 8 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 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?
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment. (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT00559910, 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 16 Oct 2018.