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NCT03344406 · ClinicalTrials.gov registry record

A Study to Evaluate Conceptual Saturation of Evaluating Respiratory Symptoms (E-RS) in Subjects With Asthma

A clinical trial of Asthma, sponsored by GlaxoSmithKline.

Completed
Registry status
25
Enrollment target
1
Study location

NCT03344406 is a study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 25 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03344406, a study of Asthma, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
25 participants
Enrollment target
1
Study location

Study Summary

Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory conditions involving the small airways with airflow limitations resulting from genetic and environmental interactions. Currently, there are no existing subject diaries with evidence of responsiveness to measure the daily symptoms of asthma. Therefore, there is a need to either develop a new symptom diary to characterize subject burden of asthma symptoms or modify/adapt an existing tool from a related disease area for use in subjects with moderate to severe asthma. The E-RS in COPD (E-RS: COPD®) questionnaire was developed as a measure of daily respiratory symptoms associated with COPD. The fixed dose combination of fluticasone furoate/ umeclidinium/ vilanterol (FF/UMEC/VI) administered via the ELLIPTA® dry powder inhaler (DPI) has been developed for the treatment of asthma. This cross-sectional, qualitative study is designed to understand the symptoms and disease experience of subjects with moderate to severe asthma. This study will also evaluate underlying concepts that are most important to asthmatic subjects compared to symptoms and concepts included in the E-RS: COPD and two supplemental asthma items (wheeze and shortness of breath with physical activity). Approximately 32 subjects will be included in the study and interviewed via telephone. Each interview including time for consent, qualitative interview, and completion of case report forms (CRFs) is expected to last approximately 60 to 90 minutes. Subjects will be expected to complete a daily diary for the next 7 days, following the initial telephone interview. E-RS: COPD and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.

Conditions Studied

Asthma

Interventions

  • OTHER Telephonic interviews
  • OTHER E-RS: COPD
  • OTHER Supplemental asthma items
  • OTHER Daily diary
  • OTHER Sociodemographic questionnaire

Study Locations (1)

Pennsylvania

  • GSK Investigational Site - Pittsburgh

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2017-12-01
Est. Completion 2018-09-10

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT03344406

The ClinicalTrials.gov registry entry for NCT03344406 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 5 interventions - of which Telephonic interviews is the first listed.

NCT03344406 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03344406 about?

NCT03344406 is a clinical study titled "A Study to Evaluate Conceptual Saturation of Evaluating Respiratory Symptoms (E-RS) in Subjects With Asthma". Asthma and chronic obstructive pulmonary disease (COPD) are chronic inflammatory conditions involving the small airways with airflow limitations resulting from genetic and environmental interactions. Currently, there are no existing subject diaries with evidence of responsiveness to measure the dail...

What is the current status of trial NCT03344406?

This trial is currently completed. The enrollment target is 25 participants. The study started on 2017-12-01. Estimated completion is 2018-09-10.

What conditions does trial NCT03344406 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT03344406?

The interventions under investigation include: Telephonic interviews (OTHER), E-RS: COPD (OTHER), Supplemental asthma items (OTHER), Daily diary (OTHER), Sociodemographic questionnaire (OTHER).

Who is sponsoring clinical trial NCT03344406?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03344406 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.