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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 ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01696214
First Posted: September 28, 2012
Last Update Posted: October 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joe Ramsdell, University of California, San Diego
  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 250 mg/salmeterol 50 mg Drug: Montelukast 10mg Drug: Theophylline 400 mg Drug: ipratropium Phase 4

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Asthma Control Test [ Time Frame: Outcome measures were determined at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and0 that a follow-up visit 1 month off study drug. Mean scores over the 24 weeks of treatment were compared. ]
    The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score <16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.


Secondary Outcome Measures:
  • The Asthma Symptom Utility Index(AUSI) [ Time Frame: Outcome measures were determined at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and0 that a follow-up visit 1 month off study drug. Mean scores over the 24 weeks of treatmen ]
    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.

  • Physiologic Measures Were Determined at the Initial Visit, at Randomization Following a wash-in Period of 1 Month, Monthly for 24 Weeks and0 That a Follow-up Visit 1 Month Off Study Drug. Mean Scores Over the 24 Weeks of Treatment Were Compared. [ Time Frame: At each visit ]
    Physiologic measures of FEV1, FVC and FEV1/FVC ratio


Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: November 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Ipratropium
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and placebo montelukast.
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.
Other Name: Atrovent
Placebo Comparator: Theophylline
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.
Drug: Theophylline 400 mg
Participants will be assigned to theophylline once a day for 24 weeks
Placebo Comparator: Montelukast
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.
Drug: Montelukast 10mg
Participants will be assigned to montelukast once a day for 24 weeks.
Other Name: Singulair
Placebo Comparator: fluticasone 250 mg/salmeterol 50mg
Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.
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
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 a placebo design 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 montelukast, Placebo, Placebo
  • Advair 100/50 and theophylline, Placebo, Placebo
  • Advair 100/50 and ipratropium, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696214


Locations
United States, California
Airway Research & Clinical Tirals Center
San Diego, California, United States, 92103
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:
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 ( Other Grant/Funding Number: National Heart, Lung, and Blood Institute (NHLBI) )
First Submitted: June 25, 2012
First Posted: September 28, 2012
Results First Submitted: August 8, 2016
Results First Posted: October 12, 2016
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: results will be presented been publication four-minute meetings

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

Additional relevant MeSH terms:
Fluticasone
Salmeterol Xinafoate
Ipratropium
Theophylline
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Montelukast
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Cholinergic Antagonists
Cholinergic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors