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

This study is not yet open for participant recruitment.
Verified June 2012 by University of California, San Diego
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joe Ramsdell, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01696214
First received: June 25, 2012
Last updated: September 27, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: fluticasone and salmeterol
Drug: Leukotriene receptor antagonist
Drug: Theophylline
Drug: Tiotropium
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: SAPS:Smoking Asthmatics Pilot Study:

Resource links provided by NLM:

MedlinePlus related topics: Asthma Smoking
U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Asthma Control Test and other symptomatic measures: [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    The primary symptomatic measure proposed for the full-scale TOM Trial, the Asthma Control Test (ACT) has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults.The Treatment Response Score (TRS) is the second composite measure proposed for the full scale TOM Trial. The TRS composite score has been informative in multicenter trials involving ICS and montelukast in childhood asthma.


Secondary Outcome Measures:
  • The Asthma Symptom Utility Index(AUSI) & Physiologic measures [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    The Asthma Symptom Utility Index(AUSI), an important secondary outcome in the proposed full-scale TOM Trial, has also been shown to be useful in tracking the frequency and severity of asthma-related symptoms in non-smoking asthmatics.The composite score of Episodes of Poor Asthma Control (EPAC) is an important outcome measure incorporating multiple dimensions of asthma including physiology, symptoms and healthcare use. Physiologic measures of FEV1, FVC and FEV1/FVC ratio. Will also be measured at each visit.


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tiotropium
Participants will be assigned to a 24 week treatment of tiotropium.
 Drug: Tiotropium
Participants will be assigned to Tiotropium 18 ug once a day for 24 weeks.
Other Name: Tiotropium 18 ug
Active Comparator: Theophylline
Participants will be assigned to Theophylline once a day for 24 weeks.
 Drug: Theophylline
Participants will be assigned to Theophylline once a day for 24 weeks
Other Name: Theophylline 400 mg
Active Comparator: Leukotriene Receptor Antagonist
Participants will be assigned to Montelukast once a day for 24 weeks.
 Drug: Leukotriene receptor antagonist
Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks.
Other Name: Montelukast 10mg
Active Comparator: fluticasone and salmeterol
Participants will be assigned to inhaled fluticasone/salmeterol twice a day for 24 weeks.
 Drug: fluticasone and salmeterol
Drug: Fluticasone/salmeterol Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo
Other Name: Advair(fluticasone/salmeterol)250/50

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696214

Locations
United States, California
Airway Research & Clinical Tirals Center Recruiting
San Diego, California, United States, 92103
Contact: Paul Ferguson, RT     619-471-0821     pferguson@ucsd.edu    
Contact: Katie Kinninger, RT     888-827-3247        
Principal Investigator: Joe Ramsdell, MD            
Sponsors and Collaborators
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Joe Ramsdell, MD UCSD
  More Information

Additional Information:
Airway Research & Clinical Trials Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Joe Ramsdell, Medical Doctor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01696214     History of Changes
Other Study ID Numbers: ARCTC-09, IR34HL109482-01A1
Study First Received: June 25, 2012
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
asthma,smokers

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Theophylline
Salmeterol
Albuterol
Fluticasone
Tiotropium
Montelukast
 Leukotriene Antagonists
Fluticasone, salmeterol drug combination
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013