AsthmaPhase 4AERONCT00495612
A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
A Phase 4 study testing Omalizumab in people with Asthma, run by Genentech, Inc..
Trial summary
This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction induced by environmental cat dander exposure in patients 18-65 years old with stable… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form.
- 18 to 65 years of age and in general good health.
- History of moderate asthma, defined by the need for routine inhaled corticosteroids for at least the last 90 days prior to screening as well as the routine use of additional medication(s) (eg, short- or long-acting β2-agonists, leukotriene antagonist, or theophylline) to control asthma symptoms.
- History of cat dander-induced asthma in the 3 years prior to randomization.
- Cat exposure at the time of screening must remain constant throughout the duration of the study (eg, patients having cat exposure at home must continue to have regular exposure during the study; patients having no cat exposure at home must continue having no exposure at home during the study).
- Positive skin test to cat allergen, defined as a ≥ 5 mm wheal over the saline control wheal.
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- Baseline forced expiratory volume in 1 second (FEV1) ≥ 70% predicted after withholding long-acting β2-agonists for > 36 hours and short-acting β2-agonists for > 6 hours.
- Eligibility per the study drug dosing table (serum IgE level ≥ 30 to ≤ 700 IU/mL and body weight ≥ 30 to ≤ 150 kg) and ability to be dosed per the dosing table.
- Less than 10 pack-years of smoking history.
- Demonstrated ≥ 20% fall in FEV1 during up to 1 hour of exposure in the cat environmental exposure chamber and ability to withstand exposure for at least 20 minutes.
Who cannot join
- Unstable asthma (defined as a hospitalization within the prior 6 months or an exacerbation requiring oral corticosteroids within 4 weeks of study entry).
- Life-threatening episode of asthma in the previous year.
- History of severe allergic reactions to cat exposure.
- Having undergone cat immunotherapy within 6 months prior to screening.
- Upper respiratory infection within 2 weeks of study entry.
- Active lung disease other than asthma.
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- Significant medical illness other than asthma, including malignancies, parasitic infections, immune system disorders, and thrombocytopenia.
- History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to omalizumab (eg, monoclonal antibodies, polyclonal gamma globulin).
- Documented medical history of anaphylaxis.
- Receipt of other investigational drugs within 30 days or 5 half-lives prior to screening, whichever is longer.
- Pregnant women and nursing mothers.
- Treatment with omalizumab within 12 months prior to screening.
- History of drug or alcohol abuse that, in the judgment of the investigator, may put the patient at risk for being unable to participate fully in the study.
About this study
Official title: A Phase IV, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction induced by environmental cat dander exposure in patients 18-65 years old with stable, moderate asthma and a history of cat dander-induced asthma symptoms.
Read the detailed description
A cat dander allergen challenge model was used to collect data for all of the Outcome Measures. The cat allergen levels in the model are similar to those found in homes with cats and are capable of inducing lower- and upper-airway responses that have been used to assess the efficacy of several asthma and allergy therapies.
Cat allergen exposure was performed in a room furnished with upholstered furniture, a blanket, and a cat litter box. The door was kept closed at all times, except when personnel or study patients were entering or leaving the room. The ventilation system was operating at all times except during cat allergen challenges. Two neutered adult cats were kept in the room at all times and were free to move about except during challenges, at which time they are placed in wire cages. Immediately before a challenge, the blanket was shaken vigorously to distribute cat allergen throughout the room.
- Conditions
- Asthma
- Being tested
- Omalizumab, Placebo
- Keywords
- Xolair, Allergic asthma, Cat allergy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called Xolair
Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.
PlaceboDrug
Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. Receives: Drug: Omalizumab |
| Placebo | Placebo comparator | Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Over a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of the baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.
Measured: Week 16
Secondary outcomes (5)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1) at 20 Minutes of a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.
Measured: Week 16
Maximum Percent Change in Forced Expiratory Volume in 1 Second (FEV1) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.
Measured: Week 16
Area Under the Curve (AUC) of Change in Chest Symptom Score During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
The chest symptom score was defined as the total of 4 sub-scores: Chest tightness, wheezing, shortness of breath, and cough. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum chest symptom score was 12 points. A lower score indicates a reduced response to the allergen exposure and fewer respiratory symptoms.
Measured: Week 16
Area Under the Curve (AUC) of Change in Nasal-ocular Symptom Score (NOSS) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
The NOSS was defined as the total of 4 sub-scores: Nasal congestion, rhinorrhea, nasal pruritus, ocular pruritus, and ocular tearing. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum NOSS was 15 points. A lower score indicates a reduced response to the allergen exposure and fewer nasal-ocular symptoms.
Measured: Week 16
Duration of Allergen Exposure During the Cat Allergen Exposure Challenge at Week 16
The challenge was stopped if a patient stated that they were extremely uncomfortable and would like to leave the room, the FEV1 has decreased by 50% from the baseline value, or after 60 minutes of exposure. The duration of allergen exposure was the time from when the patient entered the exposure room until the challenge stopped, with a maximum of 60 minutes. A longer duration indicates greater tolerance of the allergen exposure.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Solari, MD, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495612
- Sponsor's protocol ID
- Q4229n
- Acronym
- AERO
- Status last verified
- May 2017
- First submitted
- 29 Jun 2007
- Last updated
- 8 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
- ClinicalTrials.gov ID
- NCT00495612
- Acronym / sponsor ID
- AERO / Q4229n
- Conditions
- Asthma
- Keywords
- Xolair, Allergic asthma, Cat allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007 (actual)
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Jul 2007 (estimated)
- Results
- Posted 27 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction induced by environmental cat dander exposure in patients 18-65 years old with stable, moderate asthma and a history of cat dander-induced asthma symptoms.
Detailed description
A cat dander allergen challenge model was used to collect data for all of the Outcome Measures. The cat allergen levels in the model are similar to those found in homes with cats and are capable of inducing lower- and upper-airway responses that have been used to assess the efficacy of several asthma and allergy therapies.
Cat allergen exposure was performed in a room furnished with upholstered furniture, a blanket, and a cat litter box. The door was kept closed at all times, except when personnel or study patients were entering or leaving the room. The ventilation system was operating at all times except during cat allergen challenges. Two neutered adult cats were kept in the room at all times and were free to move about except during challenges, at which time they are placed in wire cages. Immediately before a challenge, the blanket was shaken vigorously to distribute cat allergen throughout the room.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: OmalizumabPatients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table. |
| Placebo | Placebo comparator | Drug: PlaceboPatients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent form.
- 18 to 65 years of age and in general good health.
- History of moderate asthma, defined by the need for routine inhaled corticosteroids for at least the last 90 days prior to screening as well as the routine use of additional medication(s) (eg, short- or long-acting β2-agonists, leukotriene antagonist, or theophylline) to control asthma symptoms.
- History of cat dander-induced asthma in the 3 years prior to randomization.
- Cat exposure at the time of screening must remain constant throughout the duration of the study (eg, patients having cat exposure at home must continue to have regular exposure during the study; patients having no cat exposure at home must continue having no exposure at home during the study).
Key exclusion criteria (13 listed)
- Unstable asthma (defined as a hospitalization within the prior 6 months or an exacerbation requiring oral corticosteroids within 4 weeks of study entry).
- Life-threatening episode of asthma in the previous year.
- History of severe allergic reactions to cat exposure.
- Having undergone cat immunotherapy within 6 months prior to screening.
- Upper respiratory infection within 2 weeks of study entry.
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 |
|---|---|---|
| OmalizumabAlso: XolairOmalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection. | Drug | Omalizumab |
| PlaceboPlacebo contained the same ingredients as the omalizumab formulation, excluding omalizumab. | Drug | Placebo |
Primary outcome
Area Under the Curve (AUC) of Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Over a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
Time frame: Week 16
Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of the baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.
5 secondary outcomes
Percent Change in Forced Expiratory Volume in 1 Second (FEV1) at 20 Minutes of a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
Time frame: Week 16
Maximum Percent Change in Forced Expiratory Volume in 1 Second (FEV1) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
Time frame: Week 16
Area Under the Curve (AUC) of Change in Chest Symptom Score During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
Time frame: Week 16
Area Under the Curve (AUC) of Change in Nasal-ocular Symptom Score (NOSS) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
Time frame: Week 16
Duration of Allergen Exposure During the Cat Allergen Exposure Challenge at Week 16
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Solari, MD study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omalizumab in people with 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 10 inclusion and 13 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 8 Jun 2017. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Curve (AUC) of Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Over a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16 (time frame: Week 16). 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 8 Jun 2017.