AsthmaNCT05157087
XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States
An observational study of Asthma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Omalizumab
- How many people
- 16,246 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 1 Dec 2020
- 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: asthmatic patients, aged 6-11, with omalizumab use
Who may be able to join
- We used all eligible Marketscan beneficiaries with an asthma diagnosis and omalizumab use between 07/07/2016 - 12/31/2018 (index period). Continuous enrollment in the Marketscan database was required to ensure the availability of claims data to capture study outcomes and covariates.
- Omalizumab cohort was defined as ≥1 prescription claims within the index period, with the date of first dispensing deemed the index date.
- Asthma was defined by ≥1 diagnosis code in any available diagnosis field on or prior to index date.
- ICD-9-CM: 493.xx OR ICD-10-CM: J45.x
- 6-11 years of age at the time of index
- ≥12-months pre-index and ≥12-months post-index continuous eligibility in medical and pharmacy benefits
- Enrollment gap of ≤30 days will be considered continuous enrollment
Who cannot join
- Patients were excluded from the study if they had one or more of the following:
- Bronchial Thermoplasty at any time during data capture. Current Procedural Terminology (CPT): 31660, 31661
- Prior asthma-indicated biologic use during the 12 months pre or post-index
- Omalizumab:
- NDC: 50242004062; 50242004201 or HCPCS: J2357; S0107; C9217
- Mepolizumab:
Show all 13Show fewer
- NDC: 00173088101, 00173088185 or HCPCS: J2182
- Reslizumab:
- NDC: 5931061031 or HCPCS: J2786
- Benralizumab:
- NDC: 0310173030 or HCPCS: C9466
- Dupilumab:
- NDC: 0024591400 or 0024591800
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigational Site
East Hanover, New Jersey, 07936-1080
About this study
A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months
Read the detailed description
This was a retrospective database pre-post cohort study, identifying asthmatic patients with omalizumab use over 24 months. Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab claims. "Responders" were defined as individuals with at least 4 omalizumab claims. Descriptive statistics are provided for both groups, but outcomes are reported only for responders.
For this study, any persons from the Marketscan database with an asthma diagnosis and >= 1 omalizumab prescription/administration during the index period were identified. From this patient population the inclusion and exclusion criteria were applied, resulting in the final study cohort. Each person was assigned an index date based on their initial use of omalizumab.
Study Period: 07/07/2015 - 12/31/2019 Index Period: 07/07/2016 - 12/31/2018 Index Date: The date of the first medical or pharmacy claim of omalizumab Baseline Period (pre-index): 12 months before index date Follow up Period (post-index): 12 months after index date
The MarketScan® Claims Database (including commercial and Medicaid claims) was used. The claims database included data from 07/08/2015 - 12/31/2019. The MarketScan® Databases capture personspecific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The current study used the Commercial, Medicare Supplemental and Multi-State Medicaid Databases.
- Conditions
- Asthma
- Being tested
- Omalizumab
- Keywords
- Asthma,, Omalizumab (Xolair),, Asthma Control,, Corticosteroids,, Pediatric,, Children,, Adolescents,, Healthcare Expenditures
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab prescription. "Responders" were defined as individuals with at least 4 administrations of omalizumab.
| Study group | Role | What they receive |
|---|---|---|
| Commercial Population | Individuals with at least one omalizumab prescription in the Marketscan commercial claims during the identification period (07/07/2016 - 12/31/2018) Receives: Drug: Omalizumab | |
| Medicaid Population | Individuals with at least one omalizumab prescription in the Truven Medicaid claims during the identification period (07/07/2016 - 12/31/2018) Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with uncontrolled asthma (impairment + risk criteria) post omalizumab treatment initiation
Uncontrolled asthma was based on either impairment or risk criteria in a 12- month consecutive period.
- Impairment was identified as ≥6 Short-acting Beta Agonist (SABA) prescriptions dispensed in 12 months. Each prescription should reflect one month days supply.
- Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only [ICD-9 code 493.xx, ICD-10 code J45.xx]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position.
- The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria) or the first exacerbation outcome during a consecutive 12-months (risk criteria).
Measured: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with excessive SABA use (≥6 SABA prescriptions dispensed in 12 months) (impairment criteria)
Proportion of patients with uncontrolled asthma (impairment criteria) were reported. Impairment was identified as ≥6 SABA prescriptions dispensed in 12 months. Each prescription should reflect one month days supply.
- The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria).
Measured: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with exacerbations requiring IP visits (risk criteria)
Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only [ICD-9 code 493.xx, ICD-10 code J45.xx]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position.
- The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).
Measured: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with exacerbations requiring ED visits (risk criteria)
Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only [ICD-9 code 493.xx, ICD-10 code J45.xx]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position.
- The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).
Measured: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with exacerbations requiring Oral corticosteroids (OCS) prescriptions (risk criteria)
Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only [ICD-9 code 493.xx, ICD-10 code J45.xx]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position.
- The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).
Measured: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean daily dose of Inhaled Corticosteroids (ICS) use
Mean daily dose of Inhaled Corticosteroids (ICS) use was reported during the follow-up
Measured: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean cumulative dose of OCS use
Mean cumulative dose of Oral corticosteroids were reported during follow-up
Measured: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean number of prescriptions of OCS use
Mean number of prescriptions of OCS use were reported during follow-up
Measured: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean days of supply of OCS use
Mean days of supply of OC were reported during follow-up
Measured: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Secondary outcomes (10)
Proportion of uncontrolled asthma patients (total: risk and impairment criteria)
Uncontrolled asthma was based on either impairment or risk criteria in a 12- month consecutive period.
- Impairment was identified as ≥6 Short-acting Beta Agonist (SABA) prescriptions dispensed in 12 months. Each prescription should reflect one month days supply.
- Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only [ICD-9 code 493.xx, ICD-10 code J45.xx]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position.
- The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria) or the first exacerbation outcome during a consecutive 12-months (risk criteria).
Measured: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Proportion of uncontrolled asthma patients (per impairment criteria)
Proportion of patients with uncontrolled asthma (impairment criteria) were reported. Impairment was identified as ≥6 SABA prescriptions dispensed in 12 months. Each prescription should reflect one month days supply.
- The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria).
Measured: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Proportion of uncontrolled asthma patients (per risk criteria)
Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only [ICD-9 code 493.xx, ICD-10 code J45.xx]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position.
- The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).
Measured: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Mean difference in the total number of asthma-related prescriptions
Mean difference in the total number of asthma-related prescriptions between baseline and follow-up periods were reported
Measured: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Mean difference in daily dose (of days supply) of ICS use
Mean difference in daily dose (of days supply) between baseline and follow-up periods were reported
Measured: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Proportion of patients with a reduction in daily dose of ICS use
Proportion of patients with a reduction in daily dose between the baseline and follow-up periods were reported
Measured: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Mean difference in daily dose of OCS use
Mean difference in daily dose between baseline and follow-up periods were reported
Measured: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Mean difference in number of prescriptions of OCS use
Mean difference in number of prescriptions between baseline and follow-up periods were reported
Measured: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Mean difference in days of supply of OCS use
Mean difference in days of supply between baseline and follow-up periods were reported
Measured: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Proportion of patients with a reduction in total prescriptions of OCS use
Proportion of patients with a reduction in total prescriptions for OCS use between baseline and follow-up periods were reported
Measured: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Mar 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 16,246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157087
- Sponsor's protocol ID
- CIGE025AUS55
- Status last verified
- Dec 2021
- First submitted
- 30 Nov 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States
- ClinicalTrials.gov ID
- NCT05157087
- Acronym / sponsor ID
- CIGE025AUS55
- Conditions
- Asthma
- Keywords
- Asthma,, Omalizumab (Xolair),, Asthma Control,, Corticosteroids,, Pediatric,, Children,, Adolescents,, Healthcare Expenditures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16,246 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 14 Dec 2021 (actual)
- 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.
A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months
Detailed description
This was a retrospective database pre-post cohort study, identifying asthmatic patients with omalizumab use over 24 months. Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab claims. "Responders" were defined as individuals with at least 4 omalizumab claims. Descriptive statistics are provided for both groups, but outcomes are reported only for responders.
For this study, any persons from the Marketscan database with an asthma diagnosis and >= 1 omalizumab prescription/administration during the index period were identified. From this patient population the inclusion and exclusion criteria were applied, resulting in the final study cohort. Each person was assigned an index date based on their initial use of omalizumab.
Study Period: 07/07/2015 - 12/31/2019 Index Period: 07/07/2016 - 12/31/2018 Index Date: The date of the first medical or pharmacy claim of omalizumab Baseline Period (pre-index): 12 months before index date Follow up Period (post-index): 12 months after index date
The MarketScan® Claims Database (including commercial and Medicaid claims) was used. The claims database included data from 07/08/2015 - 12/31/2019. The MarketScan® Databases capture personspecific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The current study used the Commercial, Medicare Supplemental and Multi-State Medicaid Databases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial Population | – | Drug: OmalizumabIndividuals with at least one omalizumab prescription in the Marketscan commercial claims during the identification period (07/07/2016 - 12/31/2018) |
| Medicaid Population | – | Drug: OmalizumabIndividuals with at least one omalizumab prescription in the Truven Medicaid claims during the identification period (07/07/2016 - 12/31/2018) |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- asthmatic patients, aged 6-11, with omalizumab use
Key inclusion criteria (7 listed)
- We used all eligible Marketscan beneficiaries with an asthma diagnosis and omalizumab use between 07/07/2016 - 12/31/2018 (index period). Continuous enrollment in the Marketscan database was required to ensure the availability of claims data to capture study outcomes and covariates.
- Omalizumab cohort was defined as ≥1 prescription claims within the index period, with the date of first dispensing deemed the index date.
- Asthma was defined by ≥1 diagnosis code in any available diagnosis field on or prior to index date.
- ICD-9-CM: 493.xx OR ICD-10-CM: J45.x
- 6-11 years of age at the time of index
Key exclusion criteria (13 listed)
- Bronchial Thermoplasty at any time during data capture. Current Procedural Terminology (CPT): 31660, 31661
- Prior asthma-indicated biologic use during the 12 months pre or post-index
- NDC: 50242004062; 50242004201 or HCPCS: J2357; S0107; C9217
- NDC: 00173088101, 00173088185 or HCPCS: J2182
- NDC: 5931061031 or HCPCS: J2786
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 |
|---|---|---|
| OmalizumabOmalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab prescription. "Responders" were defined as individuals with at least 4 administrations of omalizumab. | Drug | Commercial Population, Medicaid Population |
Primary outcome
Proportion of patients with uncontrolled asthma (impairment + risk criteria) post omalizumab treatment initiation
Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Uncontrolled asthma was based on either impairment or risk criteria in a 12- month consecutive period. * Impairment was identified as ≥6 Short-acting Beta Agonist (SABA) prescriptions dispensed in 12 months. Each prescription should reflect one month days supply. * Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only [ICD-9 code 493.xx, ICD-10 code J45.xx]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. * The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria) or the first exacerbation outcome during a consecutive 12-months (risk criteria).
Proportion of patients with excessive SABA use (≥6 SABA prescriptions dispensed in 12 months) (impairment criteria)
Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with uncontrolled asthma (impairment criteria) were reported. Impairment was identified as ≥6 SABA prescriptions dispensed in 12 months. Each prescription should reflect one month days supply. - The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria).
Proportion of patients with exacerbations requiring IP visits (risk criteria)
Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only [ICD-9 code 493.xx, ICD-10 code J45.xx]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. - The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).
Proportion of patients with exacerbations requiring ED visits (risk criteria)
Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only [ICD-9 code 493.xx, ICD-10 code J45.xx]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. - The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).
Proportion of patients with exacerbations requiring Oral corticosteroids (OCS) prescriptions (risk criteria)
Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only [ICD-9 code 493.xx, ICD-10 code J45.xx]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. - The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).
Mean daily dose of Inhaled Corticosteroids (ICS) use
Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean daily dose of Inhaled Corticosteroids (ICS) use was reported during the follow-up
Mean cumulative dose of OCS use
Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean cumulative dose of Oral corticosteroids were reported during follow-up
Mean number of prescriptions of OCS use
Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean number of prescriptions of OCS use were reported during follow-up
Mean days of supply of OCS use
Time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)
Mean days of supply of OC were reported during follow-up
10 secondary outcomes
Proportion of uncontrolled asthma patients (total: risk and impairment criteria)
Time frame: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Proportion of uncontrolled asthma patients (per impairment criteria)
Time frame: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Proportion of uncontrolled asthma patients (per risk criteria)
Time frame: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Mean difference in the total number of asthma-related prescriptions
Time frame: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Mean difference in daily dose (of days supply) of ICS use
Time frame: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Proportion of patients with a reduction in daily dose of ICS use
Time frame: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Mean difference in daily dose of OCS use
Time frame: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Mean difference in number of prescriptions of OCS use
Time frame: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Mean difference in days of supply of OCS use
Time frame: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
Proportion of patients with a reduction in total prescriptions of OCS use
Time frame: through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)
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 Dec 2021.
- Results for CIGE025AUS55 from the Novartis Clinical Trials WebsiteLink 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Novartis Pharmaceuticals at 1 site 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 7 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Proportion of patients with uncontrolled asthma (impairment + risk criteria) post omalizumab treatment initiation (time frame: 12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)). The study lists 9 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 Dec 2021.