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
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Asthma:
- 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
corticosteroids)
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
|