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

Asthma Clinical Trial

— SAPS  

Official title:

SAPS:Smoking Asthmatics Pilot Study:

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696214
• Other study ID #: ARCTC-09
• Secondary ID: IR34HL109482-01A
• Status: Completed
• Phase: Phase 4
• Start date: October 2012
• Est. completion date: November 2016

Study information

• Verified date: January 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

Intervention

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
• Montelukast 10mg
Participants will be assigned to montelukast once a day for 24 weeks.
• Theophylline 400 mg
Participants will be assigned to theophylline once a day for 24 weeks
• 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.

Locations

Country	Name	City	State
United States	Airway Research & Clinical Trials Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Asthma Symptom Utility Index (ASUI)	The Asthma Symptom Utility Index (ASUI), 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. ASUI is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects. 11 items are reviewed, with 2-week recall to assess four symptoms (cough, wheeze, shortness of breath, and awakening at night) and medication side-effects each on two dimensions (frequency and severity). 4-point Likert scale is used to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe). Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The change between two time points, initial visit and after 24 weeks of treatment, is reported. The median value is reported with the standard deviation.	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
Secondary	Percent (%) Perdicted FEV1 Changes	Physiologic measures of % predicted FEV1	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

External Links

•   Airway Research & Clinical Trials Center