Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate H… (NCT06618105) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of Albuterol Base/Inh) of Macleods Pharmaceuticals Ltd
India144 participantsStarted 2024-10-15
Plain-language summary
This is a pharmacodynamic bioequivalence bronchoprovocation study using single-dose, double-blind, double-dummy, randomized, study consisting of four study treatments (zero dose \[Placebo\], E.Q. 90 mcg Base dose of R inhalation aerosol, E.Q. 180 mcg Base dose of R inhalation aerosol, E.Q. 90 mcg Base dose of T inhalation aerosol) and four Periods (Period 1 to Period 4). Randomization procedure at Period 1 will assign any one study treatment to be administered in each Period in a cross-over manner. By the end of Period 4, a subject who completes dosing in all four Periods would have administered all four treatments in the study.
The efficacy variable, post-dose PC20 obtained during each Period is the provocative concentration of the methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of albuterol (or placebo) by inhalation. The 20% reduction in FEV1 is determined as compared to post-saline FEV1 measured before the Placebo or Albuterol administration.
The pharmacodynamic equivalence will be based on the dose-scale method of analysis of the post-dose PC20 If the 90% confidence interval for the relative bioavailability (F) falls within 67.00% -150.00% then it will be considered that pharmacodynamic equivalence is established.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and non-pregnant, non-lactating female subjects aged between 18 to 65 years (both ages inclusive)
. Stable mild asthmatics based on National Asthma Education and Prevention Programme (NAEPP) guidelines
. Subjects who were diagnosed by physician with mild asthma at least 6 months prior to screening visit date
. Pre-bronchodilator forced expiratory volume in one second (FEV1) ≥ 80% of predicted
. Airway responsiveness to methacholine demonstrated by pre-albuterol-dose (baseline) PC20 less than or equal to 1.56 mg/mL using AeroEclipse II BAN and 1-minute tidal breathing method at Screening MCT A
. The ≥20% reduction in FEV1 at Screening MCT A relative to post-saline FEV1 should be obtained above the lowest methacholine concentration
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-dose PC20 (MG/ML)
Timeframe: Post-dose following single-dose administration of differing doses of albuterol or placebo by inhalation, a total of approximately 5 weeks.
. At Screening MCT-B, subjects should have at least four-fold increase in PC20 over Screening MCT-A
. At Screening MCT -B, the ≥ 20% reduction in FEV1 relative to post saline FEV1 must be obtained up to methacholine concentration 24.96 mg/mL
Exclusion criteria
.History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season 4.History of cystic fibrosis, bronchiectasis or other respiratory diseases other than asthma (e.g., COPD, interstitial lung disease) 5.Treatment in an emergency room or hospitalization for acute asthmatic symptoms within past three months prior to screening visit 6.Need for daily oral corticosteroids within past three months prior to screening visit 7.History of life-threatening asthma leading to hospitalization within the past 1 year prior to screening visit 8.Known intolerance or hypersensitivity to any component of the albuterol metered dose inhaler (MDI) 9.Uncontrolled hypertension (systolic BP \>200 mmHg, or diastolic BP \>100 mmHg) 10.History or evidence of myocardial infarction or stroke 11.History of known aortic aneurysm 12.Current use of cholinesterase inhibitor medication (for myasthenia gravis) 13.Clinically significant ECG recording at screening such as flattening of T wave, prolongation of QTc interval (\>450 milliseconds), and ST segment depression, which in the opinion of the Investigator, would compromise subject's safety or interfere with the study results 14.History of recent eye surgery or intracranial pressure elevation risk 15.Uncontrolled diabetes (HbA1c ≥9%) at screening 16.Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled artery disease, cardiac dysrhythmia, or ECG with evidence of ischemic heart disease. In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other disease or that, in the opinion of the Investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbates in the study 17.Presence of any abnormal clinically significant laboratory investigation at screening visit 18.History of paradoxical bronchospasm 19.Has participated in another investigational study or device research study within 30 days before screening visit date 20.Women are pregnant, breast-feeding, or planning pregnancy during study
. Baseline FEV1 should not be less than 70% of predicted normal value and should be within 88 -112% of qualifying day FEV1 value.
Qualifying day: Scr-MCT A PC20 is obtained and the results of the Scr-MCT A on this day confirms that subject has met inclusion criteria 4, 5, and 6
. Baseline FEV1 should be ≥ 1.5 L
. Baseline FEV1 should meet FEV1 acceptability criteria as mentioned in ATS 2019 standards
. Baseline FEV1 should meet repeatability quality grade A, B, or C as mentioned in ATS 2019 standards
. Fall in FEV1 due to the saline control (i.e. post-saline FEV1) should not be more than 10% from the baseline FEV1 Post-saline FEV1: is the highest post-saline FEV1 value from at least one acceptable FEV1 maneuver obtained after nebulization with normal saline is completed (i.e. after saline control test is completed)
. At least one FEV1 obtained after saline control test (post-saline FEV1) should meet acceptability criteria mentioned in ATS 2019 standards