AsthmaPhase 2NCT02219048

An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma

A Phase 2 study testing PF-03715455 in people with Asthma, run by Pfizer at 28 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
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: 51 participants
Where: 28 sitesUnited States
Study dates: Nov 2014to 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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with a physician documented history or diagnosis of persistent asthma (according to GINA, 2014 definition of asthma),
Pre bronchodilator FEV1 of greater than or equal to 50 and less that 80% of predicted.
Subjects defined as GINA Step 4 on a stable dose of either fluticasone/salmeterol combination therapy, or budesonide/formoterol combination therapy or mometasone/formoterol combination therapy.
Subjects who are defined as uncontrolled as evidenced by; Juniper Asthma Control Questionnaire (5 item version, ACQ) score greater than or equal to 1.5 and less than or equal to 3.0)

Who cannot join

Subjects diagnosed with chronic pulmonary disease (COPD) and/or other chronic pulmonary diseases (eg, Occupational asthma, pulmonary fibrosis, bronchiectasis, Allergic bronchopulmonary aspergillosis (ABPA), pneumoconiosis, sarcoidosis, tuberculosis).
Subjects who are current smokers.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Chesapeake Clinical Research, Inc.
Baltimore, Maryland, 21236
The Asthma and Allergy Center
Bellevue, Nebraska, 68123
Clinical Research Center of Alabama
Birmingham, Alabama, 35209
American Health Research
Charlotte, North Carolina, 28277
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
Colorado Allergy and Asthma Centers, PC
Denver, Colorado, 80230
California Research Medical Group, Inc
Fullerton, California, 92835
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615
The Allergy & Asthma Clinic of Central Texas
Killeen, Texas, 76542
Little Rock Allergy & Asthma Clinical Research Center
Little Rock, Arkansas, 72205-4565
California Allergy and Asthma Medical Group, Inc.
Los Angeles, California, 90025
Jonathan Corren MD, Inc.
Los Angeles, California, 90025
University of Wisconsin School of Medicine & Public Health
Madison, Wisconsin, 53792
Clinical Research Institute
Minneapolis, Minnesota, 55402
North Shore Long Island Jewish Health System
New Hyde Park, New York, 11040
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747
Pulmonary Associates, Pa
Phoenix, Arizona, 85006
University of Pittsburgh Asthma Institute
Pittsburgh, Pennsylvania, 15213
Integrated Research Group, Incorporated
Riverside, California, 92506
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Allergy Associates Medical Group
San Diego, California, 92108
Washington University School of Medicine
St Louis, Missouri, 63110
Associated Specialists in Medicine, PC
St Louis, Missouri, 63141
The Clinical Research Center, L.L.C.
St Louis, Missouri, 63141
University of South Florida - Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, 33613
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27103
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-03715455 ADMINISTERED TWICE DAILY BY INHALATION FOR 12 WEEKS IN SUBJECTS WITH PERSISTENT MODERATE TO SEVERE ASTHMA WHO REMAIN UNCONTROLLED DESPITE TREATMENT WITH INHALED CORTICOSTEROIDS (ICS) AND LONG-ACTING BETA2 AGONISTS (LABA)

The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy.

Read the detailed description

Study terminated on 7th April 2015. The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study

Conditions: Asthma
Being tested: Placebo, PF-03715455
Keywords: Asthma, Staged withdrawal of background therapy
Medical subject headings: Asthma

What participants receive

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

PlaceboDrug
680 micrograms BID, Orally inhaled placebo for 12 weeks
PF-03715455Drug
680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks

Study groups in NCT02219048
Study group	Role	What they receive
Placebo	Placebo comparator	Matched blinded placebo Receives: Drug: Placebo
PF-03715455	Experimental	PF-03715455 Receives: Drug: PF-03715455

What is being measured

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

Percentage of Participants With Asthma Worsening Events
Asthma worsening was defined as one of the following events: greater than or equal to (>=) 30% reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; >=6 additional rescue puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; deterioration of asthma (as determined by the Investigator) requiring systemic steroid treatment, an increase in inhaled corticosteroids >=4 times the last dose received prior to discontinuation from the study, or hospitalization due to asthma.
Measured: Baseline up to follow-up period (Week 16)

Secondary outcomes (9)

Time to Asthma Worsening Event
The time post randomization that the first asthma worsening event occurred (defined above).
Measured: Baseline up to follow-up period (Week 16)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Baseline was defined as the latest measurement before first dosing.
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Forced Vital Capacity (FVC)
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6)
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration.
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Asthma Symptom Scores
Participants used a daily diary assessment to record overall asthma symptom scores twice a day (morning and evening). Questions included extent of albuterol use, symptoms of wheezing, breathlessness, chest tightness, and cough. The visit dependent asthma symptom scores were calculated based on the item in the daily diary assessment. A participant summarized her/his daily frequency of asthma symptoms during the last 24 hours by the assignment of an integer score (0,1,2,3 or 4). The score=0 value denoted the day without symptoms and the score=4 value denoted the day where symptoms occurred all of the time. The asthma symptom scores were calculated by averaging the values of the daily scores within visit-dependent time window. Higher score indicates asthma worsening
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4
Number of Night Time Awakenings Per Week
The number of nocturnal awakenings due to asthma symptoms was recorded by the participant.
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF)
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. The changes from baseline (CFB) at each week and over 4 weeks were analyzed.
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4
The 5-question version of the Juniper ACQ is a validated questionnaire to evaluate asthma control. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of <= 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4
Number of Daily Puffs of Rescue Medication
The use of rescue bronchodilators (albuterol or levalbuterol) for symptomatic relief of asthma in a 24-hour period was recorded by the participant.
Measured: Baseline, Week 1, Week 2, Week 3, and Week 4

Timeline

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

Nov 2014May 2015

First posted18 Aug 2014 (estimated)
Study startNov 2014
Primary completionMay 2015
Study completionMay 2015

Why it stopped: The termination was due to business reasons. No safety 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 AsthmaStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02219048
Sponsor's protocol ID: A9111007
Other IDs: INHALED P38I ASTHMA
Status last verified: May 2019
First submitted: 14 Aug 2014
Last updated: 12 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-03715455 ADMINISTERED TWICE DAILY BY INHALATION FOR 12 WEEKS IN SUBJECTS WITH PERSISTENT MODERATE TO SEVERE ASTHMA WHO REMAIN UNCONTROLLED DESPITE TREATMENT WITH INHALED CORTICOSTEROIDS (ICS) AND LONG-ACTING BETA2 AGONISTS (LABA)
ClinicalTrials.gov ID: NCT02219048
Acronym / sponsor ID: A9111007
Conditions: Asthma
Keywords: Asthma, Staged withdrawal of background therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study
Enrolment: 51 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2014 (actual)
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 18 Aug 2014 (estimated)
Results: Posted 12 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy.

Detailed description

Study terminated on 7th April 2015. The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboMatched blinded placebo
PF-03715455	Experimental	Drug: PF-03715455PF-03715455

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects with a physician documented history or diagnosis of persistent asthma (according to GINA, 2014 definition of asthma),
Pre bronchodilator FEV1 of greater than or equal to 50 and less that 80% of predicted.
Subjects defined as GINA Step 4 on a stable dose of either fluticasone/salmeterol combination therapy, or budesonide/formoterol combination therapy or mometasone/formoterol combination therapy.
Subjects who are defined as uncontrolled as evidenced by; Juniper Asthma Control Questionnaire (5 item version, ACQ) score greater than or equal to 1.5 and less than or equal to 3.0)

Key exclusion criteria (2 listed)

Subjects diagnosed with chronic pulmonary disease (COPD) and/or other chronic pulmonary diseases (eg, Occupational asthma, pulmonary fibrosis, bronchiectasis, Allergic bronchopulmonary aspergillosis (ABPA), pneumoconiosis, sarcoidosis, tuberculosis).
Subjects who are current smokers.

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
Placebo680 micrograms BID, Orally inhaled placebo for 12 weeks	Drug	Placebo
PF-03715455680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks	Drug	PF-03715455

Primary outcome

Percentage of Participants With Asthma Worsening Events
Time frame: Baseline up to follow-up period (Week 16)
Asthma worsening was defined as one of the following events: greater than or equal to (>=) 30% reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; >=6 additional rescue puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; deterioration of asthma (as determined by the Investigator) requiring systemic steroid treatment, an increase in inhaled corticosteroids >=4 times the last dose received prior to discontinuation from the study, or hospitalization due to asthma.

9 secondary outcomes

Time to Asthma Worsening Event
Time frame: Baseline up to follow-up period (Week 16)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6)
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Asthma Symptom Scores
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Number of Night Time Awakenings Per Week
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF)
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Number of Daily Puffs of Rescue Medication
Time frame: Baseline, Week 1, Week 2, Week 3, and Week 4

Results and safety

Results posted to the registry on 12 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Twice Daily	26	5
PF-03715455 680 mcg Twice Daily	25	4

Primary outcome: Percentage of Participants With Asthma Worsening Events

Time frame: Baseline up to follow-up period (Week 16). Number. Unit: percentage of participants

Measure	Placebo Twice Daily n = 26	PF-03715455 680 mcg Twice Daily n = 25
Value	11.5	16.0

Population analysed: The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 1 month after end-of-treatment visit (Week 12). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Twice Daily	0 of 26 (0%)	10 of 26 (38.5%)	Not reported
PF-03715455 680 mcg Twice Daily	0 of 25 (0%)	15 of 25 (60%)	Not reported

Limitations and caveats (from the sponsor): The study was terminated early due to portfolio prioritization. Most participants observations of time to asthma worsening event were censored by the study termination.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
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.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

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

28 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 Asthma, run by Pfizer at 28 sites in United States.

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 4 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. 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 12 Jun 2019). 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?

Percentage of Participants With Asthma Worsening Events (time frame: Baseline up to follow-up period (Week 16)). 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 NCT02219048.

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 12 Jun 2019.