Pulmonary Disease, Chronic ObstructivePhase 2NCT02366637
An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
A Phase 2 study testing PF-03715455 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 5 sites in United Kingdom.
Trial summary
This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder. 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?
- PF-03715455
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Jan 2015to May 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Female subjects of non-childbearing potential and male subjects between the ages of 40 and 80 years, inclusive
- Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD and who meet the criteria for Stage II-III disease
- Subjects must have a smoking history of at least 10 pack-years
Who cannot join
- Current evidence or history within the previous 6 months of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data
- A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of Screening
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2WB
Heart of England NHS Foundation Trust
Birmingham, B9 5SS
Respiratory Medicine, Bradford Institute of Health Research
Bradford, BD9 6RJ
Nottingham University Hospital NHS Trust
Nottingham, Nottinghamshire, NG5 1PB
Medicines Evaluation Unit Ltd
Wythenshawe, Manchester, M23 9QZ
About this study
Official title: A Randomized, Double-blind, Placebo-controlled 2-way Crossover Study To Evaluate The Efficacy, Safety And Tolerability Of Pf-03715455 Administered Twice Daily By Inhalation For 4 Weeks In Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease (Copd)
This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Placebo, PF-03715455
- Keywords
- COPD, Sputum
- 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.
PlaceboDrug
Orally inhaled placebo twice a day (BID) for 4 weeks
PF-03715455Drug
680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Double blind placebo for PF-03715455 Receives: Drug: Placebo |
| PF-03715455 | Experimental | Not described Receives: Drug: PF-03715455 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
Measured: Baseline (Day 1), Day 29 (Week 4)
Secondary outcomes (5)
Change From Baseline in Sputum Cell Counts Over 4 Weeks
Sputum cell counts included total neutrophils counts and differential (percent [%]), total cell count, total macrophage count and differential (%). Change over 4 weeks was to be presented.
Measured: Baseline, Week 1 to Week 4
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1.
Measured: Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change over 4 weeks is presented.
Measured: Baseline, Week 1 to Week 4
Maximum Observed Plasma Concentrations (Cmax) of PF-03715455
Measured: Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
Trough Plasma Concentration (Ctrough) of PF-03715455
Ctrough is the concentration prior to study drug administration.
Measured: Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Study terminated on 7 April 2015 for business reasons. No safety and/or efficacy concerns contributed to the termination of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366637
- Sponsor's protocol ID
- A9111004
- Other IDs
- INHALED p38i COPD, 2014-002340-40, 2014
- Status last verified
- May 2016
- First submitted
- 2 Sep 2014
- Last updated
- 6 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled 2-way Crossover Study To Evaluate The Efficacy, Safety And Tolerability Of Pf-03715455 Administered Twice Daily By Inhalation For 4 Weeks In Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease (Copd)
- ClinicalTrials.gov ID
- NCT02366637
- Acronym / sponsor ID
- A9111004
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, Sputum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated on 7 April 2015 for business reasons. No safety and/or efficacy concerns contributed to the termination of the study
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Posted 6 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDouble blind placebo for PF-03715455 |
| PF-03715455 | Experimental | Drug: PF-03715455 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female subjects of non-childbearing potential and male subjects between the ages of 40 and 80 years, inclusive
- Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD and who meet the criteria for Stage II-III disease
- Subjects must have a smoking history of at least 10 pack-years
Key exclusion criteria (2 listed)
- Current evidence or history within the previous 6 months of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data
- A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of Screening
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 |
|---|---|---|
| PlaceboOrally inhaled placebo twice a day (BID) for 4 weeks | Drug | Placebo |
| PF-03715455680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks | Drug | PF-03715455 |
Primary outcome
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
Time frame: Baseline (Day 1), Day 29 (Week 4)
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
5 secondary outcomes
Change From Baseline in Sputum Cell Counts Over 4 Weeks
Time frame: Baseline, Week 1 to Week 4
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4
Time frame: Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks
Time frame: Baseline, Week 1 to Week 4
Maximum Observed Plasma Concentrations (Cmax) of PF-03715455
Time frame: Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
Trough Plasma Concentration (Ctrough) of PF-03715455
Time frame: Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-03715455 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 5 sites in United Kingdom.
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 2 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: stopped early, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Forced Expiratory Volume in 1 Second (FEV1) at Week 4 (time frame: Baseline (Day 1), Day 29 (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2016.