Persistent Allergic AsthmaPhase 4NCT00870584
Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
A Phase 4 study testing Omalizumab in people with Persistent Allergic Asthma, run by Novartis Pharmaceuticals at 50 sites in United States.
Trial summary
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Persistent 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
- 271 participants
- Where
- 50 sitesUnited States
- Study dates
- Mar 2009to Mar 2010
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Total Asthma Control Test (ACT) score of ≤19 plus at least one of the following in the 4 weeks preceding visit 1, on average:
- Symptoms > 2 days/week
- Night-time awakenings ≥1 time/week
- Short-acting beta2-agonist (SABA) use for symptom control >2 days/week forced expiratory volume in 1 second (FEV1) ≤ 80% predicted
Who cannot join
- History of intubation for asthma.
- An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).
- Less than 3 months of stable maintenance oral corticosteroid therapy for asthma
- Other protocol-defined inclusion/exclusion criteria applied
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
Georgia Pollens Clinical Research Centers, Inc
Albany, Georgia, 31707
Allergy Asthma and Immunology Center of Alaska
Anchorage, Alaska, 99508
Chesapeake Clinical Research
Baltimore, Maryland, 21236
Paul A Shapero, MD
Bangor, Maine, 04401
Maimonides Medical Center, Division of Pediatric Pulmonology
Brooklyn, New York, 11219
Allergy and Respiratory Center
Canton, Ohio, 44718
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Innovative Research of West Florida, Inc
Clearwater, Florida, 33756
Abraham Research, PLLC
Crescent Springs, Kentucky, 41017
Pediatric Pulmonary Associates of North Texas, PA
Dallas, Texas, 75230
Western Sky Medical Research
El Paso, Texas, 79903
Waren W. Pleskow, MD
Encinitas, California, 92024
North Texas Institute for Clinical Trials
Fort Worth, Texas, 76132
William Ebbeling, MD, Inc
Fresno, California, 93720
Palm Spring Research Institute, Inc
Hialeah, Florida, 33012
Allergy & Asthma Center of NC, PA
High Point, North Carolina, 27262
Allergy & Asthma Associates
Houston, Texas, 77054
Pediatric Care Medical Group, Inc
Huntington Beach, California, 92647
Clinical Research Center of Indiana
Indianapolis, Indiana, 46208
Jasper Summit Research, LLC
Jasper, Alabama, 35501
Baker Allergy Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035
AAPRI Clinical Research Institute
Lincoln, Rhode Island, 02865
Lynchburg Pulmonary Associates
Lynchburg, Virginia, 24501
Rx R&D
Metairie, Louisiana, 70002
Clinical Research Institute
Minneapolis, Minnesota, 55402
Montana Medical Research, Inc.
Missoula, Montana, 59808
Sneeze, Wheeze and Itch Associates, LLC
Normal, Illinois, 61761
Oklahoma Allergy & Asthma Clinic
Oklahoma City, Oklahoma, 73104
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120
Acadiana Medicine Clinic
Opelousas, Louisiana, 70570
Kansas City Allergy & Asthma Center
Overland Park, Kansas, 66210
California Allergy & Asthma Medical Group
Palmdale, California, 93551
Integrity Research, LLC
Pensacola, Florida, 32514
Asthma Allergy & Pulmonary Associates
Philadelphia, Pennsylvania, 19107
Virginia Adult and Pediatric Allergy and Asthma PC
Richmond, Virginia, 23229
Allergy Asthma Immunology of Rochester Research Center
Rochester, New York, 14618
Allergy Associates Medical Group, Inc
San Diego, California, 92120
Sansum Clinic
Santa Barbara, California, 93110
Hugh Windom, MD, PA
Sarasota, Florida, 34233
Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD
Scottsdale, Arizona, 85251
Asthma Inc.
Seattle, Washington, 98105
Chest Medicine Clinical Services
Skokie, Illinois, 60076
South Miami Clinical Research, LLC
South Miami, Florida, 33143
Pulmonary and Research Associates
Spokane, Washington, 99204
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Alan Kaufman, MD
The Bronx, New York, 10465
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606
Allergy & Asthma Clinical Research, Inc.
Walnut Creek, California, 94598
Wilmington Medical Research
Wilmington, North Carolina, 28401
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197
About this study
Official title: A 26-week Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines
- Conditions
- Persistent Allergic Asthma
- Being tested
- Omalizumab, Placebo
- Keywords
- Asthma; asthma management; asthma impairment ; Xolair ; omalizumab
- 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 lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
PlaceboDrug
Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. Receives: Drug: Omalizumab |
| Placebo | Placebo comparator | Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.
Measured: Baseline and 24 weeks
Secondary outcomes (1)
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks
The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question "What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study?" The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionMar 2010
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 Persistent Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870584
- Sponsor's protocol ID
- CIGE025AUS33
- Status last verified
- Oct 2011
- First submitted
- 25 Mar 2009
- Last updated
- 17 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 26-week Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
- ClinicalTrials.gov ID
- NCT00870584
- Acronym / sponsor ID
- CIGE025AUS33
- Conditions
- Persistent Allergic Asthma
- Keywords
- Asthma; asthma management; asthma impairment ; Xolair ; omalizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Posted 17 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines
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: OmalizumabThe determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Total Asthma Control Test (ACT) score of ≤19 plus at least one of the following in the 4 weeks preceding visit 1, on average:
Key exclusion criteria (4 listed)
- History of intubation for asthma.
- An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).
- Less than 3 months of stable maintenance oral corticosteroid therapy for asthma
- Other protocol-defined inclusion/exclusion criteria applied
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 lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site. | Drug | Omalizumab |
| PlaceboPlacebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site. | Drug | Placebo |
Primary outcome
Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
Time frame: Baseline and 24 weeks
The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged >= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.
1 secondary outcome
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omalizumab in people with Persistent Allergic Asthma, run by Novartis Pharmaceuticals at 50 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 4 inclusion and 4 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 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 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. 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 17 Nov 2011). 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 From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment (time frame: Baseline and 24 weeks). 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 17 Nov 2011.