Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644924
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
A Study Evaluating the Effect of Inhaled PT007AS MDI Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With Asthma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Randomized Double-blind Single-dose Placebo-controlled 3-Period 3-Treatment Crossover Multicenter Study to Compare the Bronchodilatory Effect and Safety of PT007 to Placebo MDI and Open-Label Ventolin Evohaler in Adult Participants With Asthma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
MITCHELL
Brief Summary:
Phase II study to investigate the therapeutic efficacy and safety of inhaled PT007 referred to as AS MDI compared with placebo MDI and open-label Ventolin Evohaler in male and female participants aged 18 to 65 years inclusive with asthma
This study consists of a screeningrun-in period a treatment period and a follow-up phone call
This study consists of a screeningrun-in period a treatment period and a follow-up phone call
Detailed Description:
This is a randomized double-blind single-dose placebo-controlled 3-period 3-treatment crossover multicenter study to assess the bronchodilatory effect and safety of AS MDI 180 μg compared with placebo MDI and open-label Ventolin Evohaler 200 μg in adult participants aged 18 to 65 years inclusive with asthma pre-bronchodilator FEV1 of 40 of the predicted normal value and demonstrated FEV1 reversibility to Ventolin hydrofluoroalkane HFA improvement in FEV1 at 30 minutes post-Ventolin HFA dosing of 12
The study duration will be a minimum of 15 days and up to a maximum of 52 days
Including
screeningrun-in period 3 to 28 days treatment period 9 to 17 days follow-up phone call 3 to 7 days after the final dose of study intervention
Eligible participants will be randomized to 1 of 6 predefined treatment sequences in a 111111 ratio Each sequence will contain AS MDI placebo MDI and Ventolin Evohaler in a randomized order
Eligible participants will receive a single dose of randomized study intervention at each of 3 treatment visits Visits 2 3 and 4 with a 3- to 7-day washout period between treatment visits
The study duration will be a minimum of 15 days and up to a maximum of 52 days
Including
screeningrun-in period 3 to 28 days treatment period 9 to 17 days follow-up phone call 3 to 7 days after the final dose of study intervention
Eligible participants will be randomized to 1 of 6 predefined treatment sequences in a 111111 ratio Each sequence will contain AS MDI placebo MDI and Ventolin Evohaler in a randomized order
Eligible participants will receive a single dose of randomized study intervention at each of 3 treatment visits Visits 2 3 and 4 with a 3- to 7-day washout period between treatment visits
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