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NCT01612936 · ClinicalTrials.gov registry record · Phase 1

T Cell Effector and Regulatory Mechanisms in Asthma

A Phase 1 study of Asthma and Allergies, sponsored by Andrew D. Luster, M.D.,Ph.D..

Completed
Registry status
Phase 1
Development phase
168
Enrollment target
1
Study location

NCT01612936: Completed Phase 1 study of Asthma and Allergies, sponsored by Andrew D. Luster, M.D.,Ph.D..

NCT01612936 is a Phase 1 study of Asthma and Allergies that has completed, run by Andrew D. Luster, M.D.,Ph.D.. The registered enrollment target is 168 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01612936, a Phase 1 study of Asthma and Allergies, has completed, sponsored by Andrew D. Luster, M.D.,Ph.D..

COMPLETED
Registry status
Phase 1
Development phase
168 participants
Enrollment target
1
Study location

Study Summary

The specific hypothesis for this study is that there are fundamental differences in T effector and T regulatory cell responses in the lung to allergens in allergic asthma (AA) when compared to allergic nonasthmatics (ANA) that account for the difference in clinical responses. We will address this by comparing T cell responses in AA versus ANA subjects. These experiments will correlate T cell responses with measures of airway physiology using state-of-the art lung imaging and examine mechanisms controlling T cell activation in the airways of AA and the function of airway T regulatory cells during AA.

Primary Outcome

The primary endpoints are differences in airway physiology and airway constriction following segmental allergen challenge (SAC) in AA and ANA subjects using positron emission tomography (PET) in combination with high-resolution computed tomography (HRCT)

Conditions Studied

Interventions

  • BIOLOGICAL Bronchoscopy, Segmental Allergen Challenge and Broncheoalveolar Lavage
  • PROCEDURE PET-CT imaging(13NN perfusion/ventilation, 18FDG inflammation, and CT imaging)

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 168 participants
Start Date 2012-09
Est. Completion 2016-09
Phase Phase 1
Andrew D. Luster, M.D.,Ph.D.

3 total trials

What the finished NCT01612936 record still lists

NCT01612936 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (89% lower).

The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Bronchoscopy, Segmental Allergen Challenge and Broncheoalveolar Lavage is the first listed.

NCT01612936 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01612936 about?

NCT01612936 is a clinical study titled "T Cell Effector and Regulatory Mechanisms in Asthma". The specific hypothesis for this study is that there are fundamental differences in T effector and T regulatory cell responses in the lung to allergens in allergic asthma (AA) when compared to allergic nonasthmatics (ANA) that account for the difference in clinical responses. We will address this by...

What is the current status of trial NCT01612936?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 168 participants. The study started on 2012-09. Estimated completion is 2016-09.

What conditions does trial NCT01612936 study?

This clinical trial studies the following conditions: Asthma, Allergies.

What interventions are being tested in trial NCT01612936?

The interventions under investigation include: Bronchoscopy, Segmental Allergen Challenge and Broncheoalveolar Lavage (BIOLOGICAL), PET-CT imaging(13NN perfusion/ventilation, 18FDG inflammation, and CT imaging) (PROCEDURE).

Who is sponsoring clinical trial NCT01612936?

This trial is sponsored by Andrew D. Luster, M.D.,Ph.D., which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01612936 being conducted?

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

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 NCT01612936's enrollment target sits among peer trials

168 178th of 374 higher than 197 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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Source: ClinicalTrials.gov NCT01612936, the US trial registry maintained by the National Library of Medicine. NCT01612936 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.