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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL135361 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| American Lung Association | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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There are currently no treatments to specifically target asthma in obese adults. This pilot study is being conducted to investigate how effective roflumilast is in treating asthma in participants that have a higher BMI. Roflumilast can induce weight loss, which may lead to improved asthma control.
The primary objective of TRIM is to perform a pilot placebo-controlled trial of roflumilast for the treatment of poorly controlled obese asthmatics.
TRIM is a 24 week, randomized, double-masked, placebo controlled trial that will enroll 38 participants.
This study will be take place in seven centers of the American Lung Association- Airways Clinical Research Centers (ALA-ACRC). The centers include: Northwestern University Feinberg School of Medicine, Mount Sinai Icahn School of Medicine, Duke University, University of Arizona, the University of Vermont, The University of Alabama Lung Health Center, and University of Illinois Breathe Chicago Center. Johns Hopkins University will be the Data Coordinating Center (DCC) for the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roflumilast 500 mcg oral tablet | Active Comparator | 500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily. |
|
| Placebo oral tablet | Placebo Comparator | 500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast 500 Mcg Oral Tablet | Drug | The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Asthma Control Test Score | The Asthma Control Test was designed to help participants describe their asthma and how it affects how they feel and what they are able to do. They choose a response based on their asthma within the last 4 weeks. Participants select how many times per week they experience different asthma symptoms and how often they had to use a rescue inhaler or nebulizer. There are 5 questions with 5 responses; 1 meaning their asthma is not well controlled or they had symptoms more frequently, through 5 meaning they feel their asthma is well controlled or they do not experience any symptoms. The primary outcome is an unadjusted comparison of 24 week change in Asthma Control Test scores between the treatment groups. | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Weight change measured in kilograms (kg). | Baseline and 24 weeks |
| Change in Asthma Symptom Utility Index (ASUI) | A 10-item questionnaire, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects, for use in clinical trials and cost-effectiveness studies in asthma. Range is 0-1. Higher score is indicative of better health. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Dixon, MD | University of Vermont | Principal Investigator |
| Robert Wise, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Lung Health Center | Birmingham | Alabama | 35294 | United States | ||
| University of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36170654 | Derived | Dixon AE, Que LG, Kalhan R, Dransfield MT, Rogers L, Gerald LB, Kraft M, Krishnan JA, Johnson O, Hazucha H, Roy G, Holbrook JT, Wise RA. Roflumilast May Increase Risk of Exacerbations When Used to Treat Poorly Controlled Asthma in People with Obesity. Ann Am Thorac Soc. 2023 Feb;20(2):206-214. doi: 10.1513/AnnalsATS.202204-368OC. |
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Recruitment began in July 2018 and last participant visit was completed on July 2021. Participants were recruited from 7 clinical sites: University of Vermont, University of Arizona, Duke, University of Illinois, Chicago, Northwestern, University of Alabama, and Mount Sinai.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Oral Tablet | 500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily. Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day. |
| FG001 | Roflumilast 500 mcg Oral Tablet | 500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily. Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Oral Tablet | 500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily. Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Change in Asthma Control Test Score | The Asthma Control Test was designed to help participants describe their asthma and how it affects how they feel and what they are able to do. They choose a response based on their asthma within the last 4 weeks. Participants select how many times per week they experience different asthma symptoms and how often they had to use a rescue inhaler or nebulizer. There are 5 questions with 5 responses; 1 meaning their asthma is not well controlled or they had symptoms more frequently, through 5 meaning they feel their asthma is well controlled or they do not experience any symptoms. The primary outcome is an unadjusted comparison of 24 week change in Asthma Control Test scores between the treatment groups. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 24 weeks |
|
24 weeks
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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 | Placebo Oral Tablet | 500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily. Placebo oral capsule: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment | Treatment emergent |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gem Roy | Johns Hopkins University | 4432875796 | groy2@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2020 | Sep 7, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 10, 2020 | Sep 7, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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|
| Placebo oral capsule | Drug | The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day. |
|
| baseline and 24 weeks |
| Change in Gastrointestinal Symptom Rating Scale (GSRS) | It has 5 subscales (Reflux, Diarrhea, Constipation, Abdominal Pain, and Indigestion Syndrome). Subscale scores range from 1 to 7 and higher scores represent more discomfort and poor health. | Baseline and 24 weeks |
| Change in Generalized Anxiety Disease (GAD-7) | GAD-7 has 7 questions. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety | baseline and 24 weeks |
| Change in Marks Asthma Quality of Life Questionnaire | 20 items with 2 week recall. Self-administered questionnaire intended for use with adults. Respondents are asked to describe how troubling particular items have been over the past four weeks. Covers both physical and emotional impact. Range 1-4. lower score is indicative of better health | baseline and 24 weeks |
| Change in SF 36 | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Range 0-100. Higher score is indicative of better health. | baseline and 24 weeks |
| Change in PHQ9 | The PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. It has 9 questions. Range 0-27, lower score is indicate of better health. | baseline and 24 weeks |
| Tucson |
| Arizona |
| 85724 |
| United States |
| University of Illinois at Chicago, Breathe Chicago Center | Chicago | Illinois | 60608 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Mount Sinai Icahn School of Medicine | New York | New York | 10029 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| University of Vermont | Colchester | Vermont | 05446 | United States |
| BG001 |
| Roflumilast 500 mcg Oral Tablet |
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily. Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Age at asthma onset (years) | Median | Inter-Quartile Range | years |
|
| Asthma Control Test at Visit 2 (V2) | Range 5-25, higher score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Asthma Symptom Utility Index | range 0-1, higher score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Marks Asthma Quality of Life | Range 1-4, lower score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Patient Health Questionnaire-9 | range 0-27, lower score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| General Anxiety Disorder-7 | range 0-27, lower score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Short form survey-36 | Range 0-100, higher score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Gastrointestinal Symptom Rating Scale | range 1-7, lower score is indicative of better health | Median | Inter-Quartile Range | units on a scale |
|
| Forced expiratory volume at one second | Median | Inter-Quartile Range | liters |
|
| Forced Vital Capacity | Median | Inter-Quartile Range | liters |
|
| Forced Expiratory Volume/Forced vital capacity | Median | Inter-Quartile Range | ratio |
|
| Methacholine PD20 | Median | Inter-Quartile Range | microgram (mcg) |
|
| Greater than/equal to 1 unscheduled health visit for asthma in prior year | Count of Participants | Participants |
|
| Greater than/equal to 1 course of oral corticosteroids in prior year | Count of Participants | Participants |
|
| OG001 | Roflumilast | 500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily. Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day |
|
|
| Secondary | Change in Weight | Weight change measured in kilograms (kg). | Posted | Median | Inter-Quartile Range | kg | Baseline and 24 weeks |
|
|
|
| Secondary | Change in Asthma Symptom Utility Index (ASUI) | A 10-item questionnaire, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects, for use in clinical trials and cost-effectiveness studies in asthma. Range is 0-1. Higher score is indicative of better health. | Posted | Median | Inter-Quartile Range | units on a scale | baseline and 24 weeks |
|
|
|
| Secondary | Change in Gastrointestinal Symptom Rating Scale (GSRS) | It has 5 subscales (Reflux, Diarrhea, Constipation, Abdominal Pain, and Indigestion Syndrome). Subscale scores range from 1 to 7 and higher scores represent more discomfort and poor health. | Posted | Median | Inter-Quartile Range | units on scale | Baseline and 24 weeks |
|
|
|
| Secondary | Change in Generalized Anxiety Disease (GAD-7) | GAD-7 has 7 questions. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety | Posted | Median | Inter-Quartile Range | units on scale | baseline and 24 weeks |
|
|
|
| Secondary | Change in Marks Asthma Quality of Life Questionnaire | 20 items with 2 week recall. Self-administered questionnaire intended for use with adults. Respondents are asked to describe how troubling particular items have been over the past four weeks. Covers both physical and emotional impact. Range 1-4. lower score is indicative of better health | Posted | Median | Inter-Quartile Range | units on scale | baseline and 24 weeks |
|
|
|
| Secondary | Change in SF 36 | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. Range 0-100. Higher score is indicative of better health. | Posted | Median | Inter-Quartile Range | units on scale | baseline and 24 weeks |
|
|
|
| Secondary | Change in PHQ9 | The PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. It has 9 questions. Range 0-27, lower score is indicate of better health. | Posted | Median | Inter-Quartile Range | units on scale | baseline and 24 weeks |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 10 |
| 16 |
| EG001 | Roflumilast 500 mcg Oral Tablet | 500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily. Roflumilast 500 Mcg Oral Tablet: The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day. | 0 | 22 | 6 | 22 | 22 | 22 |
| Headache | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Abdominal pain (umbilical hernia) | Gastrointestinal disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Congestion, runny nose, sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Treatment emergent |
|
| Acute upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Treatment emergent |
|
| Chest discomfort | Cardiac disorders | Systematic Assessment |
|
| chest pain | Cardiac disorders | Systematic Assessment | Treatment emergent |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment | Treatment emergent |
|
| Acid reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Treatment emergent |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Treatment emergent |
|
| Skin rash | General disorders | Systematic Assessment | Treatment emergent |
|
| Muscle pain/aches | Musculoskeletal and connective tissue disorders | Systematic Assessment | Treatment emergent |
|
| Any emergent symptoms | General disorders | Systematic Assessment | Treatment emergent |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |