- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04892758
Replication of the P04334 Asthma Trial in Healthcare Claims Data
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02120
- Brigham and Women's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Criteria:
Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.
Eligible cohort entry dates:
Mometasone-furoate/formoterol was approved by FDA on June 24, 2010 for the management of asthma. The initial eligible cohort entry date was the first date after June 24, 2010 for both the databases investigated (IBM MarketScan, Optum CDM). The last date eligible as cohort entry date was the end of available data for IBM MarketScan and Optum
CDM. The following eligible cohort entry dates were included:
- Optum CDM: June 24, 2010 - June 30, 2020 (end of available data)
- IBM MarketScan: June 24, 2010- December 31, 2018 (end of available data)
Inclusion Criteria:
- ≥12 years of age
A subject must have been using a medium daily dose of inhaled glucocorticosteroid (ICS) (either alone or in combination with a long-acting beta agonist (LABA)) for at least 12 weeks and must have been on a stable regimen (daily dose unchanged) for at least 2 weeks prior to Screening. Medium daily doses of ICS are defined as follows:
- >500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)
- >250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)
- >600 to 1000 mcg budesonide dry powder inhaler (DPI)
- >1000 to 2000 mcg flunisolide
- >250 to 500 mcg fluticasone
- 400 mcg MF
- >1000 to 2000 mcg triamcinolone acetonide
- Diagnosis of asthma
- A female subject of childbearing potential must have been using a medically acceptable, adequate form of birth control.
Exclusion Criteria:
- A subject who experiences an occurrence of any clinical deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) as judged by the clinical investigator at any time from the Screening Visit up to and including the Baseline Visit
- Emergency room treatment for asthma deterioration requiring systemic corticosteroid therapy or hospitalization for management of airway obstruction within the 3 months before baseline
- A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history >10 pack-years
- Visible evidence of oropharyngeal candidiasis at baseline or earlier
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Formoterol fumarate 10 mcg
Reference Group
|
Formoterol fumarate 10 mcg dispensing claim is used as the reference group.
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Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
Exposure Group
|
Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID dispensing claim is used as the exposure group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to first asthma exacerbation
Time Frame: Through study completion (a median of 134-147 days)
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Through study completion (a median of 134-147 days)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Mometasone Furoate
- Formoterol Fumarate
Other Study ID Numbers
- 2018P002966-DUP-P04334
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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