Replication of the P04334 Asthma Trial in Healthcare Claims Data

NCT04892758 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-P04334
• Study Type: observational
• Target: 10,288
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Time to first asthma exacerbation

  Through study completion (a median of 134-147 days)

Study Arms (2)

Formoterol fumarate 10 mcg

Reference Group

Drug: Formoterol fumarate 10 mcg

Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID

Exposure Group

Drug: Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID

Interventions

Formoterol fumarate 10 mcg DRUG

Formoterol fumarate 10 mcg dispensing claim is used as the reference group.

Formoterol fumarate 10 mcg

Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID DRUG

Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID dispensing claim is used as the exposure group.

Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID

Eligibility Criteria

• Age: 12 Years - 120 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• ≥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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate; Mometasone Furoate; BID protein, human

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: October 29, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)