A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial (SAPS)
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.
|Asthma||Drug: Fluticasone 250 mg/salmeterol 50 mg Drug: Montelukast 10mg Drug: Theophylline 400 mg Drug: ipratropium||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||SAPS:Smoking Asthmatics Pilot Study:|
- 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.
- 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
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||November 2016|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
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.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696214
|United States, California|
|Airway Research & Clinical Tirals Center|
|San Diego, California, United States, 92103|
|Principal Investigator:||Joe Ramsdell, MD||UCSD|