Allergic AsthmaPhase 2AQUANCT00434434

A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma

A Phase 2 study testing omalizumab in people with Allergic Asthma, run by Genentech, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Allergic 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: 61 participants
Where: No sites listed yet
Study dates: Oct 2007to Jun 2009
Phase: Phase 2
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
Meet criteria for the diagnosis of allergic asthma
Be between the ages of 18 to 65 years
Have a normal chest X-ray within 2 years of screening

Who cannot join

Need daily controller medication for asthma
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 (e.g., monoclonal antibodies, polyclonal gamma globulin)
Have a documented medical history of anaphylaxis
Have lung disease other than mild allergic asthma
Have taken other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
Are unable or unwilling to comply with study procedures and visits

Show all 11Show fewer

Are pregnant or lactating
Have significant medical illness other than asthma, including malignancies, parasitic infections, immune system disorders, and thrombocytopenia
Have been treated with omalizumab within 12 months prior to screening
Currently smoke or have a history of smoking more than 10 pack-years
Have a history of drug or alcohol abuse, which, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study

About this study

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lyophilized and Aged Liquid Omalizumab in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

Conditions: Allergic Asthma
Being tested: omalizumab, placebo
Keywords: AQUA, anti-CD11, CD11a, Asthma, Allergy
Medical subject headings: Asthma, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

omalizumabDrug
Aged Liquid; subcutaneous repeating dose
omalizumabDrug
Lyophilized; subcutaneous repeating dose
placeboDrug
Subcutaneous repeating dose

Study groups in NCT00434434
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: omalizumab
2	Experimental	Not described Receives: Drug: omalizumab
3	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)
The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.
Measured: From baseline to Week 16

Secondary outcomes (1)

Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge
FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge.
Measured: From baseline to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Jun 2009

First posted13 Feb 2007 (estimated)
Study startOct 2007
Primary completionFeb 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 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00434434
Sponsor's protocol ID: Q4160g
Acronym: AQUA
Status last verified: Dec 2022
First submitted: 11 Feb 2007
Last updated: 14 Dec 2022
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma

All Allergic Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lyophilized and Aged Liquid Omalizumab in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
ClinicalTrials.gov ID: NCT00434434
Acronym / sponsor ID: AQUA / Q4160g
Conditions: Allergic Asthma
Keywords: AQUA, anti-CD11, CD11a, Asthma, Allergy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Feb 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 13 Feb 2007 (estimated)
Results: Posted 26 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: omalizumab
2	Experimental	Drug: omalizumab
3	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Signed Informed Consent Form
Meet criteria for the diagnosis of allergic asthma
Be between the ages of 18 to 65 years
Have a normal chest X-ray within 2 years of screening

Key exclusion criteria (11 listed)

Need daily controller medication for asthma
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 (e.g., monoclonal antibodies, polyclonal gamma globulin)
Have a documented medical history of anaphylaxis
Have lung disease other than mild allergic asthma
Have taken other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer

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
omalizumabAged Liquid; subcutaneous repeating dose	Drug	1
omalizumabLyophilized; subcutaneous repeating dose	Drug	2
placeboSubcutaneous repeating dose	Drug	3

Primary outcome

Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)
Time frame: From baseline to Week 16
The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.

1 secondary outcome

Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge
Time frame: From baseline to Week 16

Results and safety

Results posted to the registry on 26 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liquid Omalizumab	23	21
Lyopholized Omalizumab	24	24
Placebo	14	13

Primary outcome: Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)

Time frame: From baseline to Week 16. Median (Full Range). Unit: concentration change

Measure	Liquid Omalizumab n = 22	Lyopholized Omalizumab n = 23	Placebo n = 13
Value	1.15 (-2.30 to 4.03)	1.85 (-1.10 to 3.50)	0.36 (-1.09 to 3.09)

Liquid Omalizumab vs Placebo: p = 0.13, Wilcoxon (Mann-Whitney)
Lyopholized Omalizumab vs Placebo: p = 0.0133, Wilcoxon (Mann-Whitney)

Population analysed: Modified intent-to-treat (ITT) population

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liquid Omalizumab	0 of 23 (0%)	7 of 23 (30.4%)	Not reported
Lyopholized Omalizumab	2 of 24 (8.3%)	6 of 24 (25%)	Not reported
Placebo	0 of 14 (0%)	5 of 14 (35.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Allergic Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma

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.

Dennis Wong, M.D. study director

Genentech, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing omalizumab 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 4 inclusion and 11 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 14 Dec 2022. 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 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?

Yes. Results are posted in the registry (first posted 26 May 2010). 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?

Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1) (time frame: From baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00434434.

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 14 Dec 2022.