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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: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02302417 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,215 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (814% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
FEV1 measures how much air a person can exhale during a forced breath in 1 second. FVC is the total amount of air exhaled during the FEV test. FEV1 and FVC were performed on Day 1 (pre- and post-bronchodilator) using spirometry. Spirometry results obtained within 6 months and were used for this study. For participants without spirometry in the past 6 months, spirometry was performed to obtain pre- and post-bronchodilator FEV1, FVC.
Interventions
- PROCEDURE Spirometry
- OTHER ACOS clinical questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,215 participants |
| Start Date | 2015-01-01 |
| Est. Completion | 2015-05-28 |
| Phase | Phase 2 |
What the finished NCT02302417 record still lists
NCT02302417 is an interventional study that assigns participants to a tested intervention. Its 1,215 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (814% higher).
The record links to 0 conditions, and to 2 interventions - of which Spirometry is the first listed.
NCT02302417 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02302417's enrollment target sits among peer trials
1,215 17th of 2000 higher than 1,984 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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