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NCT01696214 · ClinicalTrials.gov registry record · Phase 4
A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial
A Phase 4 study of Asthma, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01696214: Completed Phase 4 study of Asthma, sponsored by University of California, San Diego.
NCT01696214 is a Phase 4 study of Asthma that has completed, run by University of California, San Diego. The registered enrollment target is 20 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01696214, a Phase 4 study of Asthma, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of implementing the provisional design of the full scale TOM trial (e.g., the six month treatment period, the impact of the smoking cessation intervention). There is no active hypothesis for the Vanguard Protocol.
Primary Outcome
The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates
Conditions Studied
Interventions
- DRUG Fluticasone 250 mg/salmeterol 50 mg
- DRUG Montelukast 10mg
- DRUG Theophylline 400 mg
- DRUG ipratropium
Study Locations (1)
California
- Airway Research & Clinical Trials Center - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-11 |
| Phase | Phase 4 |
What the finished NCT01696214 record still lists
NCT01696214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which Fluticasone 250 mg/salmeterol 50 mg is the first listed.
NCT01696214 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01696214 about?
NCT01696214 is a clinical study titled "A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial". The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of implementing the provisional design of the full scale TOM trial (e.g., the six month treatment period, the impact of the smoking cessation intervention). There is no active hypothesis for the Vanguard Protoc...
What is the current status of trial NCT01696214?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2012-10. Estimated completion is 2016-11.
What conditions does trial NCT01696214 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01696214?
The interventions under investigation include: Fluticasone 250 mg/salmeterol 50 mg (DRUG), Montelukast 10mg (DRUG), Theophylline 400 mg (DRUG), ipratropium (DRUG).
Who is sponsoring clinical trial NCT01696214?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01696214 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01696214's enrollment target sits among peer trials
20 338th of 374 higher than 30 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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