A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2025-06-04

Brief Summary

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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 screening/run-in period, a treatment period, and a follow-up phone call.

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Detailed Description

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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% and ≥ 200 mL).

The study duration will be a minimum of 15 days and up to a maximum of 52 days.

Including:

screening/run-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 1:1:1:1:1:1 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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

AS MDI and placebo MDI will be blinded to all participants, study site staff, endpoint assessors, and sponsor personnel. Placebo MDI is designed to mimic the appearance, smell, and taste of AS MDI. No double-dummy will be used. Packaging and labelling of AS MDI and placebo MDI will be designed to ensure blinding.

The IRT will provide to the investigator(s) or pharmacist(s) the kit identification number to be allocated to the participant at the dispensing visits. Routines for this will be described in the IRT user manual that will be provided to each study site.

Randomized Ventolin Evohaler is open label. However, to reduce bias, dosing will be performed under the supervision of study staff, and spirometry assessments will be performed by different study personnel who will only enter the room after dosing is completed; thus, the study personnel conducting the spirometry assessments will be blinded to the identity of the study intervention."

Study Groups

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Treatment Sequence 1

Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment A (Ventolin Evohaler) , Treatment B (Placebo MDI), and Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007).

Group Type EXPERIMENTAL