DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: fluticasone and salmeterol (Drug); Leukotriene receptor antagonist (Drug); Theophylline (Drug); Tiotropium (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of California, San Diego

Official(s) and/or principal investigator(s):
Joe Ramsdell, MD, Principal Investigator, Affiliation: UCSD


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.

Clinical Details

Official title: SAPS:Smoking Asthmatics Pilot Study:

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Asthma Control Test

Secondary outcome:

The Asthma Symptom Utility Index(AUSI)

Physiologic Measures

Detailed description: The protocol is a small scale pilot of the full-scale TOM trial, and it will utilize an active control design (stepped up dose of ICS) and incorporates 4 treatment arms. In the Vanguard Protocol all participants are to complete a 4 week run-in with Advair 100/50, followed by randomization to 1 of 4 arms of study treatment. The 4 drug treatment combinations are (2 inhalers, 2 pills):

- Advair 250/50, Placebo, Placebo, Placebo

- Advair 100/50 and LTRA, Placebo, Placebo

- Advair 100/50 and Theo, Placebo, Placebo

- Advair 100/50 and tiotropium, Placebo, Placebo The 24 week treatment phase will be

followed by a 4 week washout period on Advair 100/50. There is no crossover.


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.


Inclusion Criteria:

- Gender and Age:

- Males and females, ages 18- 50

Current Smoker:

- Smoke at least 5 cigarettes per day for at least 5 years

- Positive urine cotinine test


- Physician diagnosed asthma

- Symptomatic, as evidenced by

- Use of SABA two or more times per week for relief of asthma symptoms, or

- One or more nocturnal awakenings per week for asthma symptoms ACRC - SC MEETING

- 19 MAY 2012 SAPS │ 25 Confidential, not for attribution or citation.

- Pre-BD FEV1 greater than or equal to 40% predicted

- Asthma diagnosis confirmed by either

- albuterol reversibility of FEV1 by 12% or more, or

- 20% fall in FEV1 at 8mg or less of methacholine

- If over age 45, a DLco greater than 80% predicted

- Females of childbearing potential: not pregnant, not lactating and agree to practice

an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study. Exclusion Criteria:

- Diagnosis of COPD or emphysema

- Other major chronic illnesses in the opinion of the investigator that might interfere

with the study: − e. g. including but not limited to uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, hyperthyroidism, seizure disorders, renal failure, liver disease, non-skin cancer, unstable psychiatric illness.

- Recent active substance abuse (in past 6 months)

- Lung disease other than asthma including COPD, bronchiectasis, sarcoidosis, or other

significant lung disease

- Unstable cardiac disease (decompensated CHF, unstable angina, recent MI, atrial

fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension).

- High risk of near fatal or fatal asthma as defined by the following 1-3

- ICU admission of asthma in the past year

- more than 2 hospitalizations for asthma in the previous year

- more than 3 ED visits for asthma in the previous year

- intubation or ICU admission for asthma in the past 2 years

- use of more than 2 canisters of inhaled short-acting beta2-agonist in past month

- Acute asthma exacerbation in the past 4 weeks (treatment with systemic


Locations and Contacts

Airway Research & Clinical Tirals Center, San Diego, California 92103, United States; Recruiting
Paul Ferguson, RT, Phone: 619-471-0821, Email: pferguson@ucsd.edu
Katie Kinninger, RT, Phone: 888-827-3247
Joe Ramsdell, MD, Principal Investigator
Additional Information

Airway Research & Clinical Trials Center

Starting date: October 2012
Last updated: June 11, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017