AsthmaPhase 4SAPSNCT01696214
A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial
A Phase 4 study testing Fluticasone 250 mg/salmeterol 50 mg, Montelukast 10mg and Theophylline 400 mg in people with Asthma, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone 250 mg/salmeterol 50 mg, Montelukast 10mg and Theophylline 400 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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.
Who cannot join
- 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).
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Airway Research & Clinical Trials Center
San Diego, California, 92103
About this study
Official title: SAPS:Smoking Asthmatics Pilot Study:
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Fluticasone 250 mg/salmeterol 50 mg, Montelukast 10mg, Theophylline 400 mg, ipratropium
- Keywords
- asthma,smokers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone 250 mg/salmeterol 50 mgDrug
Also called Advair(fluticasone/salmeterol)250/50
Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo
Montelukast 10mgDrug
Also called Singulair
Participants will be assigned to montelukast once a day for 24 weeks.
Theophylline 400 mgDrug
Participants will be assigned to theophylline once a day for 24 weeks
ipratropiumDrug
Also called Atrovent
Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Fluticasone 250 mg/salmeterol 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
Physiologic measures of % predicted FEV1
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Joe Ramsdell, University of California, San Diego
- Investigators
- Joe Ramsdell, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696214
- Sponsor's protocol ID
- ARCTC-09
- Other IDs
- IR34HL109482-01A1
- Acronym
- SAPS
- Status last verified
- Jan 2019
- First submitted
- 25 Jun 2012
- Last updated
- 23 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: results will be presented been publication four-minute meetings
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAPS:Smoking Asthmatics Pilot Study:
- ClinicalTrials.gov ID
- NCT01696214
- Acronym / sponsor ID
- SAPS / ARCTC-09
- Conditions
- Asthma
- Keywords
- asthma,smokers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Posted 12 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ipratropium | Placebo comparator | Drug: ipratropiumParticipants 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. |
| Theophylline | Placebo comparator | Drug: Theophylline 400 mgParticipants 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. |
| Montelukast | Placebo comparator | Drug: Montelukast 10mgParticipants 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. |
| fluticasone 250 mg/salmeterol 50mg | Placebo comparator | Drug: Fluticasone 250 mg/salmeterol 50 mgParticipants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Gender and Age:
- Males and females, ages 18- 50
- Smoke at least 5 cigarettes per day for at least 5 years
- Positive urine cotinine test
- Physician diagnosed asthma
Key exclusion criteria (13 listed)
- Diagnosis of COPD or emphysema
- Other major chronic illnesses in the opinion of the investigator that might interfere with the study:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone 250 mg/salmeterol 50 mgAlso: Advair(fluticasone/salmeterol)250/50Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo | Drug | fluticasone 250 mg/salmeterol 50mg |
| Montelukast 10mgAlso: SingulairParticipants will be assigned to montelukast once a day for 24 weeks. | Drug | Montelukast |
| Theophylline 400 mgParticipants will be assigned to theophylline once a day for 24 weeks | Drug | Theophylline |
| ipratropiumAlso: AtroventParticipants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks. | Drug | Ipratropium |
Primary outcome
Asthma Control Test
Time frame: 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.
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.
2 secondary outcomes
The Asthma Symptom Utility Index (ASUI)
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. results will be presented been publication four-minute meetings
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Ramsdell, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone 250 mg/salmeterol 50 mg, Montelukast 10mg and Theophylline 400 mg in people with Asthma, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.