Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618105
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol EQ 90 mcg of Albuterol BaseInh of Macleods Pharmaceuticals Ltd
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Single-dose Double-blind Double-dummy Four-period Four-treatment Crossover Pivotal Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol EQ 90 mcg of Albuterol BaseInh of Macleods Pharmaceuticals Ltd to Albuterol Sulfate HFA Inhalation Aerosol EQ 90 mcg of Albuterol BaseInh Distributed by Teva Pharmaceuticals USA Inc in Adult Patients With Stable Mild Asthma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 EQ 90 mcg Base dose of R inhalation aerosol EQ 180 mcg Base dose of R inhalation aerosol EQ 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 6700 -15000 then it will be considered that pharmacodynamic equivalence is established
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 6700 -15000 then it will be considered that pharmacodynamic equivalence is established
Detailed Description:
The study consists of screening period up to 10 days and four study treatments study treatment periods Period 1 Period 2 Period 3 and Period 4 and a telephonic contact on 2nd day 1 day after Period 4 dosing daylast dose of study treatment
To participate in the study every subject must provide a signed written informed consent After obtaining consent subjects eligibility to participate in the study will be confirmed during the screening period
The study involves bronchoprovocation study using methacholine as challenge agent Therefore a methacholine challenge test MCT will be conducted during screening and at each Period A MCT involves four steps Step 1 to Step 4
In Step 1 Pre-challenge Pre-salineBaseline spirometry will be conducted In Step 2 saline saline control test and spirometry Subjects will be nebulized with normal saline for 1 minute by tidal breathing method FEV1 will be obtained at about 30 seconds and 90 seconds post-nebulization
In Step 3 challenge methacholine administration and spirometry Subjects will be nebulized with doubling concentrations of methacholine for 1 minute Nebulization will start from the lowest methacholine concentration followed by higher doubling concentration until FEV1 value reduces more than or equal to 20 relative to post-saline FEV1 or the highest methacholine concentration is administered or subject is clinically unstable whichever comes first After each concentration is nebulized subjects heart rate will be measured using pulse oximeter and well-being will be checked FEV1 will be obtained at about 30 seconds and 90 seconds post-nebulization of each methacholine concentration FEV1 maneuver should meet the acceptability criteria Each FEV1 will be checked for 20 fall relative to FEV1 obtained in Step 2
In Step 4 subject recovery and spirometry Oral inhalations of recovery medication Albuterol HFA inhalation aerosol EQ 90 mcg albuterol baseinh will be administered to expedite the return of the FEV1 within 90 of FEV1 obtained in Step 1
During the study Screening-MCT A will be conducted to assess airway responsiveness to methacholine demonstrated by pre-albuterol dose baselineScr-MCTA PC20 156 mgmL
Screening-MCT B will be conducted to assess airway responsiveness to methacholine demonstrated by post-two-albuterol-doses Albuterol HFA inhalation aerosol 90 mcg of albuterol baseinh Period MCT will be conducted to obtain post-dose PC20 for the primary endpoint Study treatment dosing will be administered after Step 2 is completed and before initiation of Step 3 Subjects will administer one oral inhalation from four different inhalers with one minute interval between each oral inhalation
To participate in the study every subject must provide a signed written informed consent After obtaining consent subjects eligibility to participate in the study will be confirmed during the screening period
The study involves bronchoprovocation study using methacholine as challenge agent Therefore a methacholine challenge test MCT will be conducted during screening and at each Period A MCT involves four steps Step 1 to Step 4
In Step 1 Pre-challenge Pre-salineBaseline spirometry will be conducted In Step 2 saline saline control test and spirometry Subjects will be nebulized with normal saline for 1 minute by tidal breathing method FEV1 will be obtained at about 30 seconds and 90 seconds post-nebulization
In Step 3 challenge methacholine administration and spirometry Subjects will be nebulized with doubling concentrations of methacholine for 1 minute Nebulization will start from the lowest methacholine concentration followed by higher doubling concentration until FEV1 value reduces more than or equal to 20 relative to post-saline FEV1 or the highest methacholine concentration is administered or subject is clinically unstable whichever comes first After each concentration is nebulized subjects heart rate will be measured using pulse oximeter and well-being will be checked FEV1 will be obtained at about 30 seconds and 90 seconds post-nebulization of each methacholine concentration FEV1 maneuver should meet the acceptability criteria Each FEV1 will be checked for 20 fall relative to FEV1 obtained in Step 2
In Step 4 subject recovery and spirometry Oral inhalations of recovery medication Albuterol HFA inhalation aerosol EQ 90 mcg albuterol baseinh will be administered to expedite the return of the FEV1 within 90 of FEV1 obtained in Step 1
During the study Screening-MCT A will be conducted to assess airway responsiveness to methacholine demonstrated by pre-albuterol dose baselineScr-MCTA PC20 156 mgmL
Screening-MCT B will be conducted to assess airway responsiveness to methacholine demonstrated by post-two-albuterol-doses Albuterol HFA inhalation aerosol 90 mcg of albuterol baseinh Period MCT will be conducted to obtain post-dose PC20 for the primary endpoint Study treatment dosing will be administered after Step 2 is completed and before initiation of Step 3 Subjects will administer one oral inhalation from four different inhalers with one minute interval between each oral inhalation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None