AsthmaNCT04892758
Replication of the P04334 Asthma Trial in Healthcare Claims Data
An observational study of Asthma, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies. Read more about this study
- Who is it for?
- Ages 12 to 120 years
- Conditions the study is for
- Asthma
- What is being tested?
- Formoterol fumarate 10 mcg and Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
- How many people
- 10,288 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2020to 11 Jun 2021
- 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 12 to 120 years
- All sexes
- Child, Adult, Older adult
Study population: This study will involve a new user, parallel group, propensity score-matched, retrospective cohort design comparing mometasonefuroate/formoterol 200/10ug with formoterol 12 ug in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of mometasone-furoate/formoterol or formoterol. (Note: the formoterol dose used in the trial was 10ug ; in the replication, we will use the market available dose which is 12 ug).
Who may be able to join
- ≥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
Show all 11Show fewer
- >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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
- Conditions
- Asthma
- Being tested
- Formoterol fumarate 10 mcg, Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formoterol fumarate 10 mcgDrug
Formoterol fumarate 10 mcg dispensing claim is used as the reference group.
Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BIDDrug
Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID dispensing claim is used as the exposure group.
| Study group | Role | What they receive |
|---|---|---|
| Formoterol fumarate 10 mcg | Reference Group Receives: Drug: Formoterol fumarate 10 mcg | |
| Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID | Exposure Group Receives: Drug: Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first asthma exacerbation
Measured: Through study completion (a median of 134-147 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start29 Oct 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
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 Brigham and Women's HospitalThe 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
- 10,288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892758
- Sponsor's protocol ID
- 2018P002966-DUP-P04334
- Status last verified
- Jul 2023
- First submitted
- 14 May 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replication of the P04334 Asthma Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT04892758
- Acronym / sponsor ID
- 2018P002966-DUP-P04334
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,288 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 19 May 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.
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formoterol fumarate 10 mcg | – | Drug: Formoterol fumarate 10 mcgReference Group |
| Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID | – | Drug: Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BIDExposure Group |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This study will involve a new user, parallel group, propensity score-matched, retrospective cohort design comparing mometasonefuroate/formoterol 200/10ug with formoterol 12 ug in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of mometasone-furoate/formoterol or formoterol. (Note: the formoterol dose used in the trial was 10ug ; in the replication, we will use the market available dose which is 12 ug).
Key inclusion criteria (11 listed)
- ≥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:
- Diagnosis of asthma
- A female subject of childbearing potential must have been using a medically acceptable, adequate form of birth control.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Formoterol fumarate 10 mcgFormoterol fumarate 10 mcg dispensing claim is used as the reference group. | Drug | Formoterol fumarate 10 mcg |
| Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BIDMometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID dispensing claim is used as the exposure group. | Drug | Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID |
Primary outcome
Time to first asthma exacerbation
Time frame: Through study completion (a median of 134-147 days)
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 27 Jul 2023.
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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.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
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 Brigham and Women's Hospital 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 11 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 27 Jul 2023. 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?
Time to first asthma exacerbation (time frame: Through study completion (a median of 134-147 days)). 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 27 Jul 2023.