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A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial

NCT01696214 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-01-23

Study results available
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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.

Conditions

Interventions

DRUG

Fluticasone 250 mg/salmeterol 50 mg

Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo

DRUG

Montelukast 10mg

Participants will be assigned to montelukast once a day for 24 weeks.

DRUG

Theophylline 400 mg

Participants will be assigned to theophylline once a day for 24 weeks

DRUG

ipratropium

Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.

Sponsors & Collaborators

Principal Investigators

  • Joe Ramsdell, MD · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-05-31
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01696214 on ClinicalTrials.gov