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Completed No phase listed Observational

HERO-2: Home-Reported Outcomes With CFTR Modulator Therapy

ClinicalTrials.gov ID: NCT04798014

Public ClinicalTrials.gov record NCT04798014. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 2:06 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Home-Reported Outcomes in People With Cystic Fibrosis (CF) Taking Highly Effective Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulator Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is an observational cohort study, using data from Folia Health and the Cystic Fibrosis Foundation Patient Registry (CFFPR). Individuals taking elexacaftor/tezacaftor/ivacaftor (ETI) may be enrolled through the Folia application. During the 12-month study period, participants will be asked to track their routine treatment and medication usage, daily symptoms, and monthly review with validated patient-reported outcome (PRO) questionnaires. Participants will also be asked to self-report instances of changes to their treatment plan, and pulmonary exacerbations. There are no study-associated site visits.

Study identification

NCT ID
NCT04798014
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Indiana University
Other
Enrollment
860 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 25, 2021
Primary completion
Aug 14, 2023
Completion
Aug 14, 2023
Last update posted
Jul 27, 2026

2021 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Indiana University School of Medicine Indianapolis Indiana 46202

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04798014, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 27, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04798014 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →