Allergic AsthmaPhase 2NCT00406965
A Study to Evaluate the Safety and Efficacy of HAE1 in Subjects With Moderate to Severe Allergic Asthma
A Phase 2 study testing HAE1 (PRO98498) in people with Allergic Asthma, run by Genentech, Inc..
Trial summary
This is a Phase II, multicenter, randomized, double blind, placebo controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of subcutaneously administered HAE1 in subjects 12-75 years old with moderate to severe asthma whose symptoms are inadequately controlled with moderate to… Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- HAE1 (PRO98498)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Sep 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed Informed Consent Form(s)
- Male and females 12-75 years of age with the diagnosis of allergic asthma for 12 months according to the standards of the American Thoracic Society
- Baseline FEV1 values ≥ 40% to ≤ 80% of the predicted normal value for the subject
- Demonstration of ≥ 12% increase in FEV1 over baseline value within 30 minutes of taking up to four puffs of albuterol (90 ug/puff)
- Treatment with ICS in doses equivalent to 250-500 ug fluticasone twice daily (BID) for 8 weeks prior to screening and as needed or regular use of bronchodilator therapy
- Treatment with a stable regimen of 50 ug salmeterol BID or 12 ug formoterol BID for at least 8 weeks prior to screening (with or without other asthma controller medications)
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- A positive radioallergosorbent test (RAST) to one or more of the pertinent perennial or seasonal allergens
- Total serum IgE level ≥ 20 to ≤ 1500 IU/mL and body weight between ≥ 40 and ≤ 150 kg
- Acceptable medical history and physical examination results
- Demonstrated ability to use Mini-Wright peak flow meter for the measurement of peak expiratory flow (PEF) and a metered dose inhaler (MDI) for administration of albuterol rescue medication
- Willingness to complete the daily diary cards
- History of smoking of less than 10 pack-years and no smoking for ≥ 12 months
- For females of childbearing potential, use an effective method of contraception from screening throughout their duration of study participation (e.g., oral, mechanical, SC, or surgical contraception)
- Inadequately controlled asthma 4 weeks during the run-in period as demonstrated by either of the following: One or more nighttime awakenings per week or Asthma symptoms during the day requiring rescue medication for 2 or more days per week
Who cannot join
- Active lung disease other than asthma
- Asthma exacerbation requiring treatment with the addition of systemic (oral or IV) corticosteroids or an increase in systemic corticosteroids within 1 month prior to screening or during the run-in period
- Significant change (e.g., 50% change) in dosage of inhaled corticosteroids in daily dose or dosing schedule within 1 month of prior to the screening visit or during the run-in period
- Significant medical illness other than asthma
- Treatment with methotrexate, gold salts, cyclosporine, theophyllines, or macrolide antibiotics within 3 months prior to screening or during the run-in period
- Treatment with HAE1
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- Any treatment with omalizumab
- Known hypersensitivity to the ingredients of the HAE1 formulation, to trial rescue medication (albuterol), or related drugs
- History of acute infectious sinusitis or respiratory tract infection within 1 month prior to screening or during the run-in period
- Aspirin or other nonsteroidal anti-inflammatory drug-related asthma
- Allergy vaccination therapy < 3 months of stable maintenance dose prior to screening
- Treatment with oral or parenteral corticosteroids within 1 month prior to screening or during the run-in period
- Current treatment with <beta>-blocker medications (e.g., propranolol)
- Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening
- Abnormal chest X-ray (excluding changes consistent with asthma) within 12 months prior to screening
- Clinically significant or active systemic disease (e.g., cancer, neoplasia, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular diseases, or endocrine or gastrointestinal disease) within 3 months of screening or during the run-in period
- Inability or unwillingness to comply with study procedures and visits (e.g., spirometry, blood draws, subject diary)
- History of drug or alcohol abuse
- Elevated serum IgE levels for reasons other than allergy (e.g., parasitic infection, hyperimmunoglobulin E syndrome, Wiskott-Aldrich syndrome, or bronchopulmonary aspergillosis)
- Pregnancy or lactation
- Platelet count ≤ 110,000/mm^3 or ≤ 110 x 10^9/L at screening or the qualifying run-in visit
- Clinically significant laboratory abnormalities, which would limit participation in the study or interfere in the interpretation of study, or affect subject safety, and evaluations at screening or the qualifying run-in visit
- Treatment with an investigational drug within 1 month of screening or during the run-in period
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of HAE1 (PRO98498) in Subjects With Moderate to Severe Allergic Asthma
This is a Phase II, multicenter, randomized, double blind, placebo controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of subcutaneously administered HAE1 in subjects 12-75 years old with moderate to severe asthma whose symptoms are inadequately controlled with moderate to high-dose ICS and LABA.
- Conditions
- Allergic Asthma
- Being tested
- HAE1 (PRO98498)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAE1 (PRO98498)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the change from baseline (Visit 1) in total asthma symptom score to Visit 10 (Day 140).
Secondary outcomes (6)
Incidence and severity of treatment-emergent adverse events and targeted adverse events and incidence of HAE-1 specific antibodies from Visit 1 to the end of the study
Change from baseline (Visit 1) in asthma symptom scores (nocturnal, morning, daytime, and total) at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
Change from baseline (Visit 1) in the number of puffs per day of beta2-agonist rescue medication at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
The rate of asthma exacerbations at Visit 10
Change from baseline (Visit 1) in the ACQ at Visits 5, 6, 7, 8, 10, 11, 12, 13, and 14 (Days 28, 56, 84, 112, 140, 168, 196, 224, and 252)
Change from baseline (Visit 1) in percent predicted forced expiratory volume in 1 second (FEV1) at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startDec 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yamo Deniz, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406965
- Sponsor's protocol ID
- HAE3973g
- Status last verified
- Dec 2007
- First submitted
- 30 Nov 2006
- Last updated
- 2 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of HAE1 (PRO98498) in Subjects With Moderate to Severe Allergic Asthma
- ClinicalTrials.gov ID
- NCT00406965
- Acronym / sponsor ID
- HAE3973g
- Conditions
- Allergic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 4 Dec 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.
This is a Phase II, multicenter, randomized, double blind, placebo controlled, multiple-dose study designed to evaluate the efficacy, safety, and tolerability of subcutaneously administered HAE1 in subjects 12-75 years old with moderate to severe asthma whose symptoms are inadequately controlled with moderate to high-dose ICS and LABA.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Signed Informed Consent Form(s)
- Male and females 12-75 years of age with the diagnosis of allergic asthma for 12 months according to the standards of the American Thoracic Society
- Baseline FEV1 values ≥ 40% to ≤ 80% of the predicted normal value for the subject
- Demonstration of ≥ 12% increase in FEV1 over baseline value within 30 minutes of taking up to four puffs of albuterol (90 ug/puff)
- Treatment with ICS in doses equivalent to 250-500 ug fluticasone twice daily (BID) for 8 weeks prior to screening and as needed or regular use of bronchodilator therapy
Key exclusion criteria (23 listed)
- Active lung disease other than asthma
- Asthma exacerbation requiring treatment with the addition of systemic (oral or IV) corticosteroids or an increase in systemic corticosteroids within 1 month prior to screening or during the run-in period
- Significant change (e.g., 50% change) in dosage of inhaled corticosteroids in daily dose or dosing schedule within 1 month of prior to the screening visit or during the run-in period
- Significant medical illness other than asthma
- Treatment with methotrexate, gold salts, cyclosporine, theophyllines, or macrolide antibiotics within 3 months prior to screening or during the run-in 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 |
|---|---|---|
| HAE1 (PRO98498) | Drug | – |
Primary outcome
The primary outcome measure is the change from baseline (Visit 1) in total asthma symptom score to Visit 10 (Day 140).
6 secondary outcomes
Incidence and severity of treatment-emergent adverse events and targeted adverse events and incidence of HAE-1 specific antibodies from Visit 1 to the end of the study
Change from baseline (Visit 1) in asthma symptom scores (nocturnal, morning, daytime, and total) at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
Change from baseline (Visit 1) in the number of puffs per day of beta2-agonist rescue medication at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
The rate of asthma exacerbations at Visit 10
Change from baseline (Visit 1) in the ACQ at Visits 5, 6, 7, 8, 10, 11, 12, 13, and 14 (Days 28, 56, 84, 112, 140, 168, 196, 224, and 252)
Change from baseline (Visit 1) in percent predicted forced expiratory volume in 1 second (FEV1) at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140).
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 2 Jan 2008.
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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.
Yamo Deniz, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HAE1 (PRO98498) in people with Allergic Asthma, run by Genentech, Inc..
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 14 inclusion and 23 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 2 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
The primary outcome measure is the change from baseline (Visit 1) in total asthma symptom score to Visit 10 (Day 140).. 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 2 Jan 2008.