Expired Study
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Encinitas, California 92024


Purpose:

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


Criteria:

Inclusion Criteria: - Mild to moderate persistent asthma (NAEPP/GINA Step 2-3) - Reversibility to albuterol at least 12% and 200 mL Exclusion Criteria: - Any significant co-morbid disease, particularly cardiovascular - Use of any maintenance therapy except short acting bronchodilators - Smoking history > or = 10 years


Study is Available At:


Original ID:

A2641021


NCT ID:

NCT00150397


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

112


Enrollment Type:


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:March 2005
Completion Date:November 2005
Completion Type:Actual
Primary Completion Date:November 2005
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 7, 2012
First Received Date:September 6, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from baseline in other lung function parameters, disease control and quality of life compared to placebo
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change from baseline in FEV1 compared to placebo
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Tofimilast

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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