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NCT02302417 · ClinicalTrials.gov registry record · Phase 2

Study Assessing Utility of a Clinical Questionnaire to Identify Subjects With Features of Both Asthma and Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
1,215
Enrollment target

NCT02302417 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,215 participants.

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The verdict

NCT02302417, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
1,215 participants
Enrollment target

Study Summary

The primary objective of the study is to identify demographic and non-spirometric clinical features predictive of the asthma-COPD overlap population. The study aims to explore and identify characteristics of the Asthma-COPD Overlap Syndrome (ACOS) patient's clinical profile that enable clinical differentiation from subjects with a primary diagnosis of either asthma alone (without persistent obstruction) or COPD alone (without reversibility). The study is designed as a targeted medical history survey which consists of a 41-item questionnaire, which will be administered by a qualified health care practitioner at the time a subject's medical history is taken. The questionnaire has been developed to elicit specific details of the respiratory history, including the following: bronchodilator use, disease progression, variation in symptoms, atopic history, symptom triggers, vagal bias, burden of disease, symptom presentation, co morbidities and age of onset. In addition, demographic information, standard medical history, co morbidity and spirometric results will also be obtained and analyzed in conjunction with the questionnaire results. Approximately 1000 subjects are required for the study.

Interventions

  • PROCEDURE Spirometry
  • OTHER ACOS clinical questionnaire

Trial Details

FieldValue
Enrollment Target 1,215 participants
Start Date 2015-01-01
Est. Completion 2015-05-28
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT02302417

The ClinicalTrials.gov registry entry for NCT02302417 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Spirometry is the first listed.

NCT02302417 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02302417 about?

NCT02302417 is a clinical study titled "Study Assessing Utility of a Clinical Questionnaire to Identify Subjects With Features of Both Asthma and Chronic Obstructive Pulmonary Disease (COPD)". The primary objective of the study is to identify demographic and non-spirometric clinical features predictive of the asthma-COPD overlap population. The study aims to explore and identify characteristics of the Asthma-COPD Overlap Syndrome (ACOS) patient's clinical profile that enable clinical diff...

What is the current status of trial NCT02302417?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,215 participants. The study started on 2015-01-01. Estimated completion is 2015-05-28.

What interventions are being tested in trial NCT02302417?

The interventions under investigation include: Spirometry (PROCEDURE), ACOS clinical questionnaire (OTHER).

Who is sponsoring clinical trial NCT02302417?

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

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

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