AsthmaPhase 2NCT00150397

A Study of the Safety and Efficacy of Tofimilast in Adult Asthmatics

A Phase 2 study testing Tofimilast in people with Asthma, run by Pfizer at 22 sites in 3 countries.

Completed

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

Trial summary

This is an initial proof of concept, phase to study to assess the safety and efficacy tofimilast for the chronic maintenance treatment of adults with persistent asthma Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Asthma
What is being tested?: Tofimilast
How many people: 112 participants
Where: 22 sitesin 3 countries
Study dates: Mar 2005to Nov 2005
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Mild to moderate persistent asthma (NAEPP/GINA Step 2-3)
Reversibility to albuterol at least 12% and 200 mL

Who cannot join

Any significant co-morbid disease, particularly cardiovascular
Use of any maintenance therapy except short acting bronchodilators
Smoking history > or = 10 years

Trial locations and contacts

22 sites in 3 countries.

Country

City, postcode or hospital

22 sites in 3 countries

United States16 sites

Pfizer Investigational Site
Atlanta, Georgia, 30281
Pfizer Investigational Site
Cincinnati, Ohio, 45241
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
DeLand, Florida, 32720
Pfizer Investigational Site
Encinitas, California, 92024
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Lincoln, Rhode Island, 02865
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Minneapolis, Minnesota, 55402
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
Normal, Illinois, 61761
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Riverside, California, 92506
Pfizer Investigational Site
Skillman, New Jersey, 08558
Pfizer Investigational Site
Springfield, Massachusetts, 01107

Other trials in United States

India4 sites

Pfizer Investigational Site
Chennai, Tamil Nadu, 600 034
Pfizer Investigational Site
Mumbai, Maharashtra, 400 014
Pfizer Investigational Site
Noida, Uttar Pradesh, 201301
Pfizer Investigational Site
Vellore, Tamil Nadu, 632002

Other trials in India

Costa Rica2 sites

Pfizer Investigational Site
Barrio Aranjuez, Provincia de San José
Pfizer Investigational Site
San José, Provincia de San José

Other trials in Costa Rica

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six-Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults With Persistent Asthma

This is an initial proof of concept, phase to study to assess the safety and efficacy tofimilast for the chronic maintenance treatment of adults with persistent asthma

Conditions: Asthma
Being tested: Tofimilast
Medical subject headings: Asthma

What participants receive

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

TofimilastDrug

What is being measured

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

Change from baseline in FEV1 compared to placebo

Secondary outcomes (1)

Change from baseline in other lung function parameters, disease control and quality of life compared to placebo

Timeline

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

Mar 2005Nov 2005

First posted8 Sep 2005 (estimated)
Study startMar 2005
Primary completionNov 2005
Study completionNov 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Double blind
Enrolment: 112 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00150397
Sponsor's protocol ID: A2641021
Status last verified: Jun 2012
First submitted: 6 Sep 2005
Last updated: 8 Jun 2012
Results posted: No

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 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six-Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults With Persistent Asthma
ClinicalTrials.gov ID: NCT00150397
Acronym / sponsor ID: A2641021
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2005
Primary completion: Nov 2005 (actual)
Study completion: Nov 2005 (actual)
First posted: 8 Sep 2005 (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.

This is an initial proof of concept, phase to study to assess the safety and efficacy tofimilast for the chronic maintenance treatment of adults with persistent asthma

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Mild to moderate persistent asthma (NAEPP/GINA Step 2-3)
Reversibility to albuterol at least 12% and 200 mL

Key exclusion criteria (3 listed)

Any significant co-morbid disease, particularly cardiovascular
Use of any maintenance therapy except short acting bronchodilators
Smoking history > or = 10 years

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
Tofimilast	Drug	–

Primary outcome

Change from baseline in FEV1 compared to placebo

1 secondary outcome

Change from baseline in other lung function parameters, disease control and quality of life compared to placebo

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 8 Jun 2012.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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

22 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tofimilast in people with Asthma, run by Pfizer at 22 sites in 3 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 2 inclusion and 3 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 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, India, Costa Rica. 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 FEV1 compared to placebo. 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 NCT00150397.

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 8 Jun 2012.