Moderate to Severe Allergic AsthmaNCT01362621
Observational and Epidemiologic Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma
An observational study of Moderate to Severe Allergic Asthma, run by Novartis Pharmaceuticals at 51 sites in 2 countries.
Trial summary
The study was designed to collect data about inadequately controlled moderate to severe allergic asthma in subjects 6 to < 12 years of age, managed in a real-world setting. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Moderate to Severe Allergic Asthma
- How many people
- 474 participants
- Where
- 51 sitesin 2 countries
- Study dates
- Feb 2008to Feb 2010
- Phase
- Observational
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 6 to less than 12 years old with moderate to severe allergic asthma for at least 12 months, treated with inhaled corticosteroids for at least 3 months but remaining symptomatic
Who may be able to join
- Total IgE ≥30 IU (historical values obtained within 3 months of screening visit will be accepted). If historic result not available, to be obtained at screening visit.
- Diagnosis of asthma for at least 12 months prior to screening visit date, or symptoms compatible with asthma for at least 12 months if diagnosis made within 12 months of screening visit
- Documented sensitivity to one or more perennial aeroallergens as evidenced by a positive skin prick test or in-vitro specific IgE test for dust mites, cat dander, dog dander or cockroach within the preceding one year of the screening visit
- Prescribed inhaled corticosteroid for at least 3 months prior to screening (A) and having evidence of inadequately controlled disease either with at least one from list (B) OR history of asthma-related exacerbations as defined in (C). [e.g., A and (B or C)]
- Fluticasone DPI > 200 mcg/day or equivalent ex-valve dose ICS, or if ≤ 200 mcg fluticasone DPI or equivalent plus another daily controller medication (i.e. LABA, leukotriene antagonist or theophylline)
- At least one of the following in the preceding 4 weeks prior to the screening visit:
Show all 12Show fewer
- on average asthma symptoms > 2 days/week or multiple times in a day on ≤ 2 days/week
- nighttime awakenings ≥ 2 times/month due to asthma symptoms
- use of SABAs > 2 times/week on average
- some limitation in activity due to asthma
- on spirometric evaluation, FEV1 ≤ 80% of predicted, FEV1/FVC ≤ 80%, or peak expiratory flow rate ≤ 80% of personal best
- Minimum of 2 asthma exacerbations requiring oral corticosteroid bursts in the 12 months previous to the screening visit
Who cannot join
- Subjects currently enrolled in a clinical study of a therapeutic agent or biologic agent or who participated in a clinical study of a therapeutic agent within 30 days of Visit 1 or a biologic agent within 120 days of Visit 1
- Subjects with a history of prior use of omalizumab
- Subjects with a severe medical condition that in the view of the investigator prohibits participation in the study by either impairment in the ability to answer questions or follow instructions (e.g., severe neurological or developmental disorder)
- Subjects with serious respiratory-related medical conditions other than allergic asthma such as, but not limited to, allergic bronchopulmonary aspergillosis, cystic fibrosis or bronchiectasis
- Subjects with elevated serum IgE levels for reasons other than allergy such as, but not limited to, parasitic infections, hyperimmunoglobulin E syndrome, and Wiskott-Aldrich Syndrome
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
United States50 sites
Novartis Investigative Site
Albany, Georgia, 31707
Novartis Investigative Site
Allentown, Pennsylvania, 18104
Novartis Investigative Site
Altoona, Pennsylvania, 16601
Novartis Investigative Site
Atlanta, Georgia, 30342
Novartis Investigative Site
Batavia, New York, 14020
Novartis Investigative Site
Bellingham, Washington, 98225
Novartis Investigative Site
Berkeley Heights, New Jersey, 07922
Novartis Investigative Site
Birmingham, Alabama, 35209
Novartis Investigative Site
Brick, New Jersey, 08724
Novartis Investigative Site
Brooklyn, New York, 11229
Novartis Investigative Site
Burlington, Massachusetts, 01801
Novartis Investigative Site
Columbus, Georgia, 31904
Novartis Investigative Site
Crescent City, California, 95531
Novartis Investigative Site
Cynthiana, Kentucky, 41031
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Emporia, Virginia, 23847
Novartis Investigative Site
Evansville, Indiana, 47713
Novartis Investigative Site
Fresno, California, 93726
Novartis Investigative Site
Gresham, Oregon, 97030
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Houston, Texas, 77054
Novartis Investigative Site
Jackson, Mississippi, 39202
Novartis Investigative Site
Kalamazoo, Michigan, 49008
Novartis Investigative Site
Kingsport, Tennessee, 37660
Novartis Investigative Site
Madison, Wisconsin, 53715
Novartis Investigative Site
Metarie, Louisiana, 70002
Novartis Investigative Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
Murray, Utah, 84107
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Oakland, California, 94609
Novartis Investigative Site
Oklahoma City, Oklahoma, 73112
Novartis Investigative Site
Omaha, Nebraska, 16945
Novartis Investigative Site
Orange, California, 92868
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15212
Novartis Investigative Site
Plymouth, Minnesota, 55441
Novartis Investigative Site
Providence, Rhode Island, 02906
Novartis Investigative Site
Rockville Centre, New York, 11570
Novartis Investigative Site
Roseville, California, 95678
Novartis Investigative Site
Sacramento, California, 95819
Novartis Investigative Site
San Diego, California, 92120
Novartis Investigative Site
Savannah, Georgia, 31406
Novartis Investigative Site
South Burlington, Vermont, 05403
Novartis Investigative Site
St Louis, Missouri, 63104
Novartis Investigative Site
Stevensville, Michigan, 49127
Novartis Investigative Site
Summit, New Jersey, 07901
Novartis Investigative Site
Thornton, Colorado, 80233
Novartis Investigative Site
Toledo, Ohio, 43604
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Walnut Creek, California, 94598
Novartis Investigative Site
West Orange, New Jersey, 07052
About this study
Official title: A 2-year Prospective, Multi-center, Observational and Epidemiologic Outcomes Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma
The study was designed to collect data about inadequately controlled moderate to severe allergic asthma in subjects 6 to < 12 years of age, managed in a real-world setting.
- Conditions
- Moderate to Severe Allergic Asthma
- Keywords
- Allergic asthma, Pediatrics, Exacerbations, Perennial aeroallergens, Inhaled corticosteroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children 6 to less than 12 years of age | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from basline in Childhood Asthma Control Test
Measured: 2 years
The change from baseline in total Wasserfallen Clinical Symptom Score
Measured: 2 years
Secondary outcomes (4)
The change from baseline for overall score in the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S))
Measured: 2 years
The change from baseline for overall score in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
Measured: 2 years
The number of days of missed school.
Measured: 2 years
The number of days of missed work.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362621
- Sponsor's protocol ID
- CIGE025BUS26
- Status last verified
- Jun 2011
- First submitted
- 26 May 2011
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-year Prospective, Multi-center, Observational and Epidemiologic Outcomes Study of the Disease Course and Unmet Needs in Children With Symptomatic Moderate to Severe Allergic Asthma
- ClinicalTrials.gov ID
- NCT01362621
- Acronym / sponsor ID
- CIGE025BUS26
- Conditions
- Moderate to Severe Allergic Asthma
- Keywords
- Allergic asthma, Pediatrics, Exacerbations, Perennial aeroallergens, Inhaled corticosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (actual)
- First posted
- 30 May 2011 (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 study was designed to collect data about inadequately controlled moderate to severe allergic asthma in subjects 6 to < 12 years of age, managed in a real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children 6 to less than 12 years of age | – | – |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 6 to less than 12 years old with moderate to severe allergic asthma for at least 12 months, treated with inhaled corticosteroids for at least 3 months but remaining symptomatic
Key inclusion criteria (12 listed)
- Total IgE ≥30 IU (historical values obtained within 3 months of screening visit will be accepted). If historic result not available, to be obtained at screening visit.
- Diagnosis of asthma for at least 12 months prior to screening visit date, or symptoms compatible with asthma for at least 12 months if diagnosis made within 12 months of screening visit
- Documented sensitivity to one or more perennial aeroallergens as evidenced by a positive skin prick test or in-vitro specific IgE test for dust mites, cat dander, dog dander or cockroach within the preceding one year of the screening visit
- Prescribed inhaled corticosteroid for at least 3 months prior to screening (A) and having evidence of inadequately controlled disease either with at least one from list (B) OR history of asthma-related exacerbations as defined in (C). [e.g., A and (B or C)]
- Fluticasone DPI > 200 mcg/day or equivalent ex-valve dose ICS, or if ≤ 200 mcg fluticasone DPI or equivalent plus another daily controller medication (i.e. LABA, leukotriene antagonist or theophylline)
Key exclusion criteria (6 listed)
- Subjects currently enrolled in a clinical study of a therapeutic agent or biologic agent or who participated in a clinical study of a therapeutic agent within 30 days of Visit 1 or a biologic agent within 120 days of Visit 1
- Subjects with a history of prior use of omalizumab
- Subjects with a severe medical condition that in the view of the investigator prohibits participation in the study by either impairment in the ability to answer questions or follow instructions (e.g., severe neurological or developmental disorder)
- Subjects with serious respiratory-related medical conditions other than allergic asthma such as, but not limited to, allergic bronchopulmonary aspergillosis, cystic fibrosis or bronchiectasis
- Subjects with elevated serum IgE levels for reasons other than allergy such as, but not limited to, parasitic infections, hyperimmunoglobulin E syndrome, and Wiskott-Aldrich Syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change from basline in Childhood Asthma Control Test
Time frame: 2 years
The change from baseline in total Wasserfallen Clinical Symptom Score
Time frame: 2 years
4 secondary outcomes
The change from baseline for overall score in the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ(S))
Time frame: 2 years
The change from baseline for overall score in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
Time frame: 2 years
The number of days of missed school.
Time frame: 2 years
The number of days of missed work.
Time frame: 2 years
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 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate to Severe Allergic Asthma, run by Novartis Pharmaceuticals at 51 sites in 2 countries.
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 12 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 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Puerto Rico. 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.
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 change from basline in Childhood Asthma Control Test (time frame: 2 years). The study lists 2 primary outcomes in all. 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 Jun 2011.