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| ID | Type | Description | Link |
|---|---|---|---|
| IR34HL109482-01A1 | Other Grant/Funding Number | National Heart, Lung, and Blood Institute (NHLBI) |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Current Smoker:
Asthma:
Physician diagnosed asthma
Symptomatic, as evidenced by
Pre-BD FEV1 greater than or equal to 40% predicted
Asthma diagnosis confirmed by either
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
Acute asthma exacerbation in the past 4 weeks (treatment with systemic corticosteroids)
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| Name | Affiliation | Role |
|---|---|---|
| Joe Ramsdell, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Airway Research & Clinical Trials Center | San Diego | California | 92103 | United States |
results will be presented been publication four-minute meetings
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipratropium | Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast. Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times |
| FG001 | 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. Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks |
| FG002 | 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. Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks. |
| FG003 | Fluticasone 250 mg/Salmeterol 50mg | Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast. Fluticasone 250 mg/salmeterol 50 mg: Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
smoking asthmatics
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| ID | Title | Description |
|---|---|---|
| BG000 | Ipratropium | Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast. Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | units on a scale | 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. |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ipratropium | Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast. Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Participant hospitalized overnight with asthma exacerbation. Study drug stopped while overnight hospitalization and continued with randomized study drug and completed double blind portion of study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| migraine headache | Nervous system disorders | Non-systematic Assessment | migraine headache |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joe Ramsdell | University of California San Diego | 619-543-7241 | jramsdell@ucsd.edu |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068299 | Salmeterol Xinafoate |
| C093875 | montelukast |
| D013806 | Theophylline |
| D009241 | Ipratropium |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| Montelukast 10mg | Drug | Participants will be assigned to montelukast once a day for 24 weeks. |
|
|
| Theophylline 400 mg | Drug | Participants will be assigned to theophylline once a day for 24 weeks |
|
| 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. |
|
|
| 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 | 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 |
| BG001 |
| Theophylline |
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast. Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks |
| BG002 | 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 tiotroprium. Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks. |
| BG003 | Fluticasone 250 mg/Salmeterol 50mg | Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast. Fluticasone 250 mg/salmeterol 50 mg: Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 montelukast.
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.
| OG001 | 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 montelukast. Theophylline 400 mg: Participants will be assigned to Theophylline once a day for 24 weeks |
| OG002 | 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 ipratropium. Montelukast 10mg: Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks. |
| OG003 | Fluticasone 250 mg/Salmeterol 50mg | Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, ipratropium, and montelukast. 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 |
|
|
| 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. | Posted | Median | Standard Deviation | units on a scale | 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 | Posted | Median | Standard Deviation | percent 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 |
|
|
|
| 0 |
| 4 |
| 4 |
| 5 |
| EG001 | Theophylline | Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast. Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks | 0 | 5 | 5 | 5 |
| EG002 | 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 tiotroprium. Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks. | 1 | 5 | 5 | 5 |
| EG003 | Fluticasone 250 mg/Salmeterol 50mg | Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast. Fluticasone 250 mg/salmeterol 50 mg: Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50 | 0 | 5 | 5 | 5 |
|
| death | Social circumstances | Non-systematic Assessment | Participant in the run-out phase with open label Advair 100/50 and was found dead. Autopsy found cause of that to be due to Phencyclidine and Cocaine Toxicity |
|
| viral infection | Infections and infestations | Non-systematic Assessment | self-limiting viral infection |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | transient back pain |
|
| drowsiness | General disorders | Non-systematic Assessment | transient drowsiness |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | transient rash |
|
| motor vehicle accident | Social circumstances | Non-systematic Assessment | motor vehicle accident with no serious injury |
|
| dry mouth | General disorders | Non-systematic Assessment | transient dry mouth |
|
| chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | transient chest wall discomfort |
|
| urinary tract infection | Renal and urinary disorders | Non-systematic Assessment | treated urinary tract infection with no recurrence |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment | transient nausea |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment | transient diarrhea |
|
| tachycardia | Cardiac disorders | Non-systematic Assessment | transient tachycardia |
|
| headache | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | musculoskeletal headache |
|
| edema | General disorders | Non-systematic Assessment | mild transient edema |
|
| skin lesion | Skin and subcutaneous tissue disorders | Non-systematic Assessment | stable keratosis |
|
| swollen hand | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | transient swollen hand |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment | transient constipation |
|
| sprained finger | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | sprained finger, recovered without difficulty |
|
| pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment | transient lower extremity itching |
|
| iritis | Eye disorders | Non-systematic Assessment | transient viral |
|
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |