NCT00330070

Brief Summary

The purpose of the study is to determine whether IPL512,602 is safe and effective for the treatment of asthma symptoms in patients who remain symptomatic on a background therapy of inhaled corticosteroids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_2 asthma

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 16, 2007

Status Verified

February 1, 2007

First QC Date

May 23, 2006

Last Update Submit

February 14, 2007

Conditions

Asthma

Keywords

8-week treatmentoral tabletspersistent moderate to severe asthmaAQLQasthma controlquality of life

Outcome Measures

Primary Outcomes (1)

  • Change in AQLQ(S) overall scores from baseline to 8 weeks post-randomization

Secondary Outcomes (8)

  • Change in AQLQ(S) individual domain scores

  • Change in asthma control

  • Change in FEV1

  • Change in morning and evening PEFR

  • Change in SABA usage

  • +3 more secondary outcomes

Interventions

IPL512,602 20 mg once dailyDRUG
IPL512,602 Matching Placebo once dailyDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • a history of persistent asthma for at least the 4 months prior to entry
  • require daily inhaled corticosteroids (220-1000 µg fluticasone equivalent per day) for at least 4 weeks prior to randomization and short-acting beta-2-agonist (SABA)
  • FEV1 at randomization (without exposure to a SABA for at least 6 hours) must be between 50% and 80% of predicted normal
  • reversibility of FEV1 by at least 12% and at least 250 mL following two to four inhalations of a SABA must be demonstrated prior to randomization
  • AQLQ(S) score of 4.5 or less at both the screening (Visit 1) and randomization (Visit 2) visits
  • patients must meet at least two out of three of the following criteria:
  • overall score minimum of 2 on Asthma Control Questionnaire (ACQ)
  • require rescue SABA use of 2 or more inhalations per day for symptom relief on at least 4 of 7 days during each week of the baseline period
  • nighttime awakenings due to asthma, an average of at least once a week during the baseline period

You may not qualify if:

  • history of chronic pulmonary diseases other than asthma, including bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, pulmonary tuberculosis, or bronchiectasis
  • other asthma therapies:
  • use of long-acting beta-2-agonists within 5 weeks prior to randomization
  • use of leukotriene modulators, theophylline, or muscarinic antagonists within 4 weeks prior to randomization
  • use of injectable or oral corticosteroids within 2 months prior to screening
  • requirement for more than 10 inhalations per day of a short-acting beta-2-agonist more than 3 times per week during the baseline period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

West Coast Clinical Trials

Long Beach, California, 90806, United States

Location

Allergy Research Foundation, Inc.

Los Angeles, California, 90025, United States

Location

Asthma Medical Group & Resarch

San Diego, California, 92123, United States

Location

San Jose Clinical Research

San Jose, California, 95128, United States

Location

Northeast Medical Research Associates, Inc

No. Dartmouth, Massachusetts, 02743, United States

Location

Clinical Research Institute of South Oregaon

Medford, Oregon, 97504, United States

Location

Allergy Associates Research Center

Portland, Oregon, 97231, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Busse William, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

  • Jonathan Corren, MD

    Allergy Research Foundatin, Inc.

    PRINCIPAL INVESTIGATOR

  • Alan Heller, MD

    San Jose Clinical Research

    PRINCIPAL INVESTIGATOR

  • Edward Kerwin, MD

    Clinical Research Institute of South Oregon

    PRINCIPAL INVESTIGATOR

  • Y. Hsu, MD

    West Coast Clinical Trials

    PRINCIPAL INVESTIGATOR

  • Eli Meltzer, MD

    Allergy and Asthma Medical Group

    PRINCIPAL INVESTIGATOR

  • S. David Miller, MD

    Northeast Medical Research Associates

    PRINCIPAL INVESTIGATOR

  • Michael J Noonan

    Allergy Associates Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 25, 2006

Study Start

May 1, 2006

Study Completion

January 1, 2007

Last Updated

February 16, 2007

Record last verified: 2007-02

Locations

US(8)