Replication of the P04334 Asthma Trial in Healthcare Claims Data

July 25, 2023 updated by: Shirley Vichy Wang, Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10288

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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).

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:

    1. >500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)
    2. >250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)
    3. >600 to 1000 mcg budesonide dry powder inhaler (DPI)
    4. >1000 to 2000 mcg flunisolide
    5. >250 to 500 mcg fluticasone
    6. 400 mcg MF
    7. >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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Formoterol fumarate 10 mcg
Reference Group
Drug: Formoterol fumarate 10 mcg
Formoterol fumarate 10 mcg dispensing claim is used as the reference group.
Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
Exposure Group
Drug: Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
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)
Through study completion (a median of 134-147 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Shirley Wang, PhD, ScM, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2020

Primary Completion (Actual)

June 11, 2021

Study Completion (Actual)

June 11, 2021

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 14, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P002966-DUP-P04334

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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