An interventional study of Weight loss intervention in Asthma, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Other
Among 33 studies in Asthma by Johns Hopkins University — 3 open to participants now, 4 under way, none of them phase 3. Asthma · Johns Hopkins University.
Among the 33 studies in Asthma by Johns Hopkins University, this one is the 20th largest by enrollment of the 30 interventional ones that give a count, is one of 3 that started in 2017, is one of 18 with no phase, and was the 27th registered.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
Browse Asthma studies →3 of the 33 studies in Asthma by Johns Hopkins University are open now, in 1 country. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Johns Hopkins University · Sites in United States
Johns Hopkins University · Sites in United States
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2017.
This study's enrollment of 43 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Median enrollment 118 across the 30 interventional studies, 350 across the 3 observational. Of the 29 that completed or were terminated, 16 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
3 of the studies in Asthma by Johns Hopkins University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06273072Johns Hopkins UniversityMetformin IN Asthma for Overweight and Obese Individuals (MINA) | 2026-12-31 |
| NCT05814510Johns Hopkins UniversityImplementation of Asthma Community Home and School Management Program (Asthma CHAMPS) | 2027-06-30 |
| NCT05004714Johns Hopkins UniversityY of Central Maryland Head Start Asthma Implementation | 2027-07-31 |
Among the 33 studies in Asthma by Johns Hopkins University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is to pilot test a weight loss intervention in obese patients with poorly controlled asthma.
Obesity is a risk factor for the development of asthma (approximately 250,000 cases per year of asthma in the U.S. are related to obesity).
Investigators' ultimate purpose is to test the hypothesis that weight loss through an intensive life style intervention will improve asthma control. But investigators first need to establish whether the weight loss intervention is effective in patients with asthma.
Objectives
This will be a pilot study of a weight loss intervention at two centers, the University of Arizona and the University of Vermont. The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control.
This will be a single arm-phase II futility trial; the "futility" to be assessed is the ability to produce weight loss. Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials. This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss). This is a 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention, which is described in detail below
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Poorly controlled asthma
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Such designs are widely used in efficiently informing decisions to proceed to Phase III clinical trials. This trial design is appropriate when the effect of the placebo arm can reasonably be estimated (weight loss is likely to be close to 0), and the toxicity of the treatment is minimal (no toxicity is anticipated related to weight loss).18 Therefore, this will be a single arm 6-month study of 40 participants (20 at each site). All participants will be assigned to the weight loss intervention.
Behavioral: Weight loss intervention
This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly "group meetings" in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months.
Weight Loss
The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control.
Time frame: 6 months
Forty-three were enrolled in the weight loss intervention in five cohorts, four English speaking and one Spanish speaking. Ten subjects dropped out before study completion, four reported this was related to research burden and six were lost to follow up: 33 participants completed the 6-month study. Recruitment was conducted at University of Vermont and University of Arizona.
| Milestone | Weight Loss Intervention |
|---|---|
| Started | 43 |
| Completed | 33 |
| Not completed | 10 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Research burden | 4 |
The primary outcome of interest will be the percent of participants achieving a 5% weight loss, which is the amount of weight loss that prior studies suggest is required to improve asthma control.
| Participants | Weight Loss Intervention |
|---|---|
| Weight Loss | 43 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Weight Loss Intervention | 0/43 (0%) | 11/43 (25.6%) | 6/43 (14%) |
| Event | Weight Loss Intervention |
|---|---|
| Asthma ExacerbationsRespiratory, thoracic and mediastinal disorders | 5/43 |
| Emergency Department visitGeneral disorders | 4/43 |
| Small bowel obstructionGastrointestinal disorders | 2/43 |
| GastroenteritisGastrointestinal disorders | 1/43 |
| Chest pain with other symptomsCardiac disorders | 1/43 |
| FallGeneral disorders | 1/43 |
| HypertensionVascular disorders | 1/43 |
| Allergic reactionImmune system disorders | 1/43 |
| Knee painMusculoskeletal and connective tissue disorders | 1/43 |
| Event | Weight Loss Intervention |
|---|---|
| Chest pain with other symptomsGeneral disorders | 6/43 |
People with poorly controlled asthma with a BMI of greater than 30
| Age, Continuous(years) | Weight Loss Intervention |
|---|---|
| Median | 48 (41 to 59) |
| Sex: Female, Male(Participants) | Weight Loss Intervention |
|---|---|
| Female | 38 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Weight Loss Intervention |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 35 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Weight Loss Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 2 |
| White | 40 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Weight Loss Intervention |
|---|---|
| United States | 43 |
| Forced Expiratory Vital Capacity %(Percent predicted) | Weight Loss Intervention |
|---|---|
| Median | 80 (69 to 97) |
| Forced Vital Capacity %(Percent predicted) | Weight Loss Intervention |
|---|---|
| Median | 85 (77 to 98) |
| Forced Expiratory Vital Capacity/Forced vital capacity(Percent predicted) | Weight Loss Intervention |
|---|---|
| Median | 79 (71 to 83) |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in May 2020, 30 months.
Results were first posted in Sep 2022, 2 years 3 months after primary completion.
Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 30 months is above that.
Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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