Replication of the D58 Asthma Trial in Healthcare Claims Data

NCT04892732 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-D58
• Study Type: observational
• Target: 66,581
• 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)

• First serious asthma-related event

  A composite of adjudicated death, intubation, and hospitalization

  Through study completion (a median of 88-116 days)

Secondary Outcomes (3)

• Asthma-related hospitalization

  Through study completion (a median of 88-116 days)

• Asthma-related intubation

  Through study completion (a median of 88-116 days)

• Asthma-related death

  Through study completion (a median of 88-116 days)

Study Arms (2)

Budesonide

Reference Group

Drug: Budesonide

Budesonide-formoterol

Exposure Group

Drug: Budesonide-Formoterol

Interventions

Budesonide DRUG

Budesonide dispensing claim is used as the reference group.

Budesonide

Budesonide-Formoterol DRUG

Budesonide-Formoterol dispensing claim is used as the exposure group.

Budesonide-formoterol

Eligibility Criteria

• Age: 12 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• 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 budesonide-formoterol versus budesonide alone. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of budesonide-formoterol or budesonide.

You may qualify if:

• ≥12 years of age
• Documented clinical diagnosis of asthma for ≥1 year prior to randomization
• History of at least one asthma exacerbation in the previous year (but none in the 4 weeks prior to randomization. An asthma exacerbation was defined as an event requiring treatment with systemic corticosteroids or requiring hospitalization (i.e. an inpatient stay or \>24-hour stay in the observation area of an emergency room or local equivalent)
• Receiving either:
• A stable dose of ICS alone or in combination with a LABA, leukotriene receptor antagonist or other maintenance therapy/therapies for ≥4 weeks prior to randomization (any patient maintained on a stable high-dose ICS with or without a LABA or LTRA or other maintenance therapy/therapies was required to have an ACQ6 total score of \<1.5 at screening) OR
• A stable dose of LTRA or xanthine monotherapy (for ≥4 weeks prior to randomization) or daily SABA (in the 4 weeks before randomization but ≤8 puffs a day on two consecutive days, or ≥25 puffs in one day, in the 7 days prior to screening). Patients on LTRAs, xanthines, or daily SABA, were eligible only if they recorded an ACQ6 total score of ≥1.5, and in the investigator's clinical judgment, the patient's asthma severity could have justified treatment with ICS or ICS/LABA combination

You may not qualify if:

• A history of life-threatening asthma (defined as an asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support)
• One of the following:
• Any asthma exacerbation requiring systemic corticosteroids within 4 weeks prior to randomization OR
• \>4 separate exacerbations OR
• \>2 hospitalizations (an inpatient stay or \>24- hour stay in the observation area of an emergency room or local equivalent) due to asthma in the previous year
• Received systemic corticosteroids for any reason in the 4 weeks prior to randomization
• Had an ongoing asthma exacerbation requiring systemic corticosteroids
• Concurrent respiratory disease (chronic obstructive pulmonary disease, chronic bronchitis, emphysema, idiopathic pulmonary fibrosis, bronchiectasis, and/or any pulmonary disease)
• A smoking history of \>10 pack-years
• Respiratory infection or other viral/bacterial illness
• Pregnancy (current/planned) and lactation
• Malignancy (with the exception of basal cell carcinoma) within the 5 years prior to study commencement
• Omalizumab or any other monoclonal/polyclonal antibody use in the 6 months prior to randomization
• Concomitant β-blocker use
• Drug/alcohol abuse

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

Budesonide; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations

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)