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

NCT01696214 | Completed Phase 4 Results DMC

• 2 other identifiers: ARCTC-09IR34HL109482-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

asthma,smokers

Outcome Measures

Primary Outcomes (1)

• Asthma Control Test

  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.

  Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.

Secondary Outcomes (2)

• The Asthma Symptom Utility Index (ASUI)

  Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and a follow-up visit 1 month off study drug. Median scores, change from initial visit and end of treatment, were compared

• Percent (%) Perdicted FEV1 Changes

  Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks. Median scores over the 24 weeks of treatment were compared

Study Arms (4)

Ipratropium

PLACEBO COMPARATOR

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

Theophylline

PLACEBO COMPARATOR

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

Montelukast

PLACEBO COMPARATOR

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

fluticasone 250 mg/salmeterol 50mg

PLACEBO COMPARATOR

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

Interventions

Fluticasone 250 mg/salmeterol 50 mg DRUG

Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo

Also known as: Advair(fluticasone/salmeterol)250/50

fluticasone 250 mg/salmeterol 50mg

Montelukast 10mg DRUG

Participants will be assigned to montelukast once a day for 24 weeks.

Also known as: Singulair

Montelukast

Theophylline 400 mg DRUG

Participants will be assigned to theophylline once a day for 24 weeks

Theophylline

ipratropium DRUG

Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.

Also known as: Atrovent

Ipratropium

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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
• % fall in FEV1 at 8mg or less of methacholine
• If over age 45, a DLco greater than 80% predicted

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)

Sponsors & Collaborators

• University of California, San Diego: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Airway Research & Clinical Trials Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Salmeterol Xinafoate; montelukast; Theophylline; Ipratropium

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Dr. Joe Ramsdell
• Organization: University of California San Diego

jramsdell@ucsd.edu

619-543-7241

Study Officials

• Joe Ramsdell, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: September 28, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2016
• Last Updated: January 23, 2019
• Results First Posted: October 12, 2016

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)