AsthmaPhase 2NCT00330070
Control of Asthma Patients Symptomatic on Inhaled Corticosteroids
A Phase 2 study testing IPL512,602 20 mg once daily in people with Asthma, run by Inflazyme Pharmaceuticals Ltd at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- IPL512,602 20 mg once daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2006to Jan 2007
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
West Coast Clinical Trials
Long Beach, California, 90806
Allergy Research Foundation, Inc.
Los Angeles, California, 90025
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Clinical Research Institute of South Oregaon
Medford, Oregon, 97504
Northeast Medical Research Associates, Inc
No. Dartmouth, Massachusetts, 02743
Allergy Associates Research Center
Portland, Oregon, 97231
Asthma Medical Group & Resarch
San Diego, California, 92123
San Jose Clinical Research
San Jose, California, 95128
About this study
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
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.
Read the 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).
- Conditions
- Asthma
- Being tested
- IPL512,602 20 mg once daily, IPL512,602 Matching Placebo once daily
- Keywords
- 8-week treatment, oral tablets, persistent moderate to severe asthma, AQLQ, asthma control, quality of life
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPL512,602 20 mg once dailyDrug
IPL512,602 Matching Placebo once dailyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Change in nighttime awakenings
Total number of asthma worsening events
Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startMay 2006
- Study completionJan 2007
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.
- 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
- 200 participants
Sponsor and investigators
- Lead sponsor
- Inflazyme Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Busse William, MD, Principal investigator, University of Wisconsin, MadisonJonathan Corren, MD, Principal investigator, Allergy Research Foundatin, Inc.Alan Heller, MD, Principal investigator, San Jose Clinical ResearchEdward Kerwin, MD, Principal investigator, Clinical Research Institute of South OregonY. Hsu, MD, Principal investigator, West Coast Clinical TrialsEli Meltzer, MD, Principal investigator, Allergy and Asthma Medical GroupS. David Miller, MD, Principal investigator, Northeast Medical Research AssociatesMichael J Noonan, Principal investigator, Allergy Associates Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330070
- Sponsor's protocol ID
- IPL512,602-2002
- Other IDs
- CAPSICS, EudraCT 2006-000840-22
- Status last verified
- Feb 2007
- First submitted
- 23 May 2006
- Last updated
- 16 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00330070
- Acronym / sponsor ID
- IPL512,602-2002
- Conditions
- Asthma
- Keywords
- 8-week treatment, oral tablets, persistent moderate to severe asthma, AQLQ, asthma control, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Inflazyme Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Jan 2007
- First posted
- 25 May 2006 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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:
- 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
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 |
|---|---|---|
| IPL512,602 20 mg once daily | Drug | – |
| IPL512,602 Matching Placebo once daily | Drug | – |
Primary outcome
Change in AQLQ(S) overall scores from baseline to 8 weeks post-randomization
8 secondary outcomes
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)
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 16 Feb 2007.
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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.
Busse William, MD principal investigator
University of Wisconsin, Madison
Jonathan Corren, MD principal investigator
Allergy Research Foundatin, Inc.
Alan Heller, MD principal investigator
San Jose Clinical Research
8 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 IPL512,602 20 mg once daily in people with Asthma, run by Inflazyme Pharmaceuticals Ltd at 8 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 9 inclusion and 6 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 16 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 in AQLQ(S) overall scores from baseline to 8 weeks post-randomization. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2007; AzTrials last refreshed its copy on 7 Nov 2026.