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

Completed · Phase 4 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01696214

Run by

University of California, San Diego

People needed

20

Starts

2012-10-01

Expected to finish

2016-11-01

Last updated by the study team

2019-01-23

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Airway Research & Clinical Trials Center — San Diego, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.