A Phase 3 interventional study of Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg and Placebo metered-dose inhaler in Exercise Induced Bronchospasm, sponsored by Bond Avillion 2 Development LP. Completed at 6 sites in United States. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-13.
Sponsored by Bond Avillion 2 Development LP · Phase 3, Interventional, and Treatment
This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test for up to 10 minutes so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated.
52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.
This study's enrollment of 60 is above the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.
Browse Asthma, Exercise-Induced studies →Bond Avillion 2 Development LP is the lead sponsor of 6 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Receiving 1 of the following asthma therapies with stable dosing for at least the 4 weeks before Visit 1; no other asthma therapies are permitted during the study:
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to receive a single dose of BDA MDI 160/180 in treatment period 1, and a single dose of Placebo MDI in treatment period 2.
Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg · Combination Product: Placebo metered-dose inhaler
Subjects randomized to receive a single dose of Placebo MDI in treatment period 1, and a single dose of BDA MDI 160/180 in treatment period 2.
Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg · Combination Product: Placebo metered-dose inhaler
Budesonide/albuterol sulfate combination inhalation aerosol single dose
Also known as: BDA MDI 160/180 μg (PT027)
Placebo inhalation aerosol single dose
Also known as: Placebo MDI
Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge
Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.
Time frame: Up to 60 minutes post exercise challenge
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10%
The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall \<10% was determined.
Time frame: Up to 60 minutes post exercise challenge
Subjects included in the study were male and female adults and adolescents 12 to 70 years of age with a diagnosis of asthma as defined by the Global Initiative for Asthma (GINA) criteria and EIB as defined by a \>=20% decrease from pre-exercise challenge best FEV₁ observed within 60 minutes after an exercise challenge at both screening visits. The first subject enrolled on 15 January 2020 and the last subject completed the study on 28 August 2020. Subjects were enrolled at 6 US study centers.
| Milestone | A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI | B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180 |
|---|---|---|
| Started | 29 | 31 |
| Completed | 29 | 31 |
| Not completed | 0 | 0 |
| Milestone | A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI | B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180 |
|---|---|---|
| Started | 29 | 31 |
| Completed | 28 | 31 |
| Not completed | 1 | 0 |
| Withdrew: Subject did not meet the pre-dose fev₁ criterion of >70% predicted at visit 4/visit 4 repeat. | 1 | 0 |
Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.
| Maximum percentage fall FEV₁ | Treatment Intervention A - BDA MDI 160/180 - All Subjects | Treatment Intervention B - Placebo MDI - All Subjects |
|---|---|---|
| Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge | 5.45 (2.56 to 8.35) | 18.97 (16.06 to 21.88) |
The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall \<10% was determined.
| Participants | Treatment Intervention A - BDA MDI 160/180 - All Subjects | Treatment Intervention B - Placebo MDI - All Subjects |
|---|---|---|
| Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10% | 47 | 17 |
Collected over Approximately one week for each treatment intervention.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Intervention - BDA MDI 160/180 - All Subjects | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Treatment Intervention - Placebo MDI - All Subjects | 0/59 (0%) | 0/59 (0%) | 2/59 (3.4%) |
| Event | Treatment Intervention - BDA MDI 160/180 - All Subjects | Treatment Intervention - Placebo MDI - All Subjects |
|---|---|---|
| AnxietyPsychiatric disorders | 0/60 | 1/59 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/60 | 1/59 |
| Age, Categorical(Participants) | A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI | B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180 | Total |
|---|---|---|---|
| <=18 years | 1 | 1 | 2 |
| Between 18 and 65 years | 27 | 30 | 57 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI | B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180 | Total |
|---|---|---|---|
| Mean | 39.1 ± 12.28 | 41.8 ± 11.31 | 40.5 ± 11.76 |
| Sex: Female, Male(Participants) | A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI | B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180 | Total |
|---|---|---|---|
| Female | 21 | 17 | 38 |
| Male | 8 | 14 | 22 |
| Ethnicity (NIH/OMB)(Participants) | A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI | B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 3 |
| Not Hispanic or Latino | 29 | 28 | 57 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI | B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 5 | 13 | 18 |
| White | 21 | 18 | 39 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI | B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180 | Total |
|---|---|---|---|
| United States | 29 | 31 | 60 |
| Height(Centimeters) | A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI | B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180 | Total |
|---|---|---|---|
| Mean | 167.0 ± 9.41 | 170.7 ± 10.28 | 168.9 ± 9.96 |
| Weight(Kilograms) | A/B - Treatment With BDA MDI 160/180 Followed by Treatment With Placebo MDI | B/A - Treatment With Placebo MDI Followed by Treatment With BDA MDI 160/180 | Total |
|---|---|---|---|
| Mean | 81.3 ± 18.50 | 84.4 ± 21.60 | 82.9 ± 20.05 |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Bond Avillion 2 Development LP