Control of Asthma Patients Symptomatic on Inhaled Corticosteroids

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

IPL512,602 20 mg once daily

IPL512,602 Matching Placebo once daily

About this trial

This is an interventional treatment trial for Asthma focused on measuring 8-week treatment, oral tablets, persistent moderate to severe asthma, AQLQ, asthma control, quality of life

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in AQLQ(S) individual domain scores

Change in asthma control

Change in FEV1

Change in morning and evening PEFR

Change in SABA usage

Change in nighttime awakenings

Total number of asthma worsening events

Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)

Full Information

NCT ID

NCT00330070

First Posted

May 23, 2006

Last Updated

February 14, 2007

Sponsor

Inflazyme Pharmaceuticals Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00330070

Brief Title

Control of Asthma Patients Symptomatic on Inhaled Corticosteroids

Official Title

An 8 Week, Randomized, Double-Blind, Parallel Group, Multicenter Trial Comparing the Efficacy and Safety of Oral IPL512,602 to Placebo in Subjects With Moderate to Severe Persistent Asthma Inadequately Controlled on Inhaled Corticosteroids

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Inflazyme Pharmaceuticals Ltd

4. Oversight

5. Study Description

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.

Detailed Description

This multicenter, randomized, double-blind, placebo-controlled, parallel group study will include subjects with persistent moderate to severe asthma who require inhaled corticosteroids and inhaled short-acting β2-agonists (SABAs). Subjects who pass screening at Visit 1 will enter a 2-3 week baseline period to confirm stable asthma symptoms and collect baseline data. Subjects will continue with ongoing prescribed treatment during this period, or as modified by the investigator based on clinical judgment. Subjects will use the SABA prescribed for them to alleviate asthma symptoms on an as needed basis throughout the study. If eligible, at Visit 2 subjects will be randomized to treatment with either IPL512,602 (20 mg) daily or placebo in a 1:1 ratio. Randomization in each treatment group will be stratified into two subgroups: those receiving low to medium doses of inhaled corticosteroids (≤500 µg per day fluticasone or equivalent) and those receiving high doses of inhaled corticosteroids (>500 µg per day fluticasone or equivalent). During the 8-week treatment period, subjects will return to the clinic after 1, 2, 4, 6, and 8 weeks of treatment (Visits 3-7). Adverse event data will be collected for 14 days following the last dose administration (Visit 8).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

8-week treatment, oral tablets, persistent moderate to severe asthma, AQLQ, asthma control, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

IPL512,602 20 mg once daily

Intervention Type

Drug

Intervention Name(s)

IPL512,602 Matching Placebo once daily

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Change in AQLQ(S) individual domain scores

Title

Change in asthma control

Title

Change in FEV1

Title

Change in morning and evening PEFR

Title

Change in SABA usage

Title

Change in nighttime awakenings

Title

Total number of asthma worsening events

Title

Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials: