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

NCT06644924 | Completed Phase 2 FDA Drug FDA Device

• 1 other identifier: D6935C00002
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 22

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

Conditions

Asthma

Keywords

Asthma, Bronchial; Bronchial Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Anti-Asthmatic Agents; Respiratory System Agents

Outcome Measures

Primary Outcomes (1)

• Change from baseline in FEV1 AUC 0-6 hours

  Change from baseline FEV1 measured at each time point. Baseline FEV1 is the period specific mean of the available pre-dose values. Area Under the Curve (AUC) is calculated for the available time points using the trapezoidal rule.

  0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)

Secondary Outcomes (2)

• Change from baseline in FEV1 AUC 0 - 4 hours

  0 to 4 hours (Spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)

• Peak Change From Baseline in FEV1

  Over 6 hours post dose

Other Outcomes (1)

• Adverse events (AE)/serious adverse events (SAE)

  From randomization throughout the treatment period and including the follow-up period (telephone contact).

Study Arms (6)

Treatment Sequence 1

EXPERIMENTAL

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).

Combination Product: Intervention: AS MDI; Combination Product: Intervention: Ventolin Evohaler; Combination Product: Intervention: Placebo matching AS MDI

Treatment Sequence 2

EXPERIMENTAL

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

Combination Product: Intervention: AS MDI; Combination Product: Intervention: Ventolin Evohaler; Combination Product: Intervention: Placebo matching AS MDI

Treatment Sequence 3

EXPERIMENTAL

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

Combination Product: Intervention: AS MDI; Combination Product: Intervention: Ventolin Evohaler; Combination Product: Intervention: Placebo matching AS MDI

Treatment Sequence 4

EXPERIMENTAL

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

Combination Product: Intervention: AS MDI; Combination Product: Intervention: Ventolin Evohaler; Combination Product: Intervention: Placebo matching AS MDI

Treatment Sequence 5

EXPERIMENTAL

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

Combination Product: Intervention: AS MDI; Combination Product: Intervention: Ventolin Evohaler; Combination Product: Intervention: Placebo matching AS MDI

Treatment Sequence 6

EXPERIMENTAL

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

Combination Product: Intervention: AS MDI; Combination Product: Intervention: Ventolin Evohaler; Combination Product: Intervention: Placebo matching AS MDI

Interventions

Intervention: AS MDI COMBINATION_PRODUCT

Drug Treatment: (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007) Randomized participants will receive a single-dose (2 inhalations)

Also known as: Albuterol Sulfate metered dose inhaler [AS MDI] - PT007)

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6

Intervention: Ventolin Evohaler COMBINATION_PRODUCT

Drug: Treatment (Ventolin Evohaler) Randomized participants will receive a single-dose (2 inhalations)

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6

Intervention: Placebo matching AS MDI COMBINATION_PRODUCT

Drug: Treatment (Placebo MDI) Randomized participants will receive a single-dose (2 inhalations to match AS MDI)

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age
• Participant must be aged 18 to 65 years (inclusive), at the time of signing the informed consent.
• Type of Participant and Disease Characteristics
• Participants should have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1.
• Must be receiving one of the following required inhaled asthma therapies listed below for at least the last 30 days:
• Only SABA, which is used as needed for rescue.
• Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy.
• Pre-BD FEV1 of ≥ 40% of the PN value at Visit 1, after withholding SABA for ≥ 6 hours (and Visit 1a and/or Visit 1b, if applicable).
• Confirmed FEV1 reversibility to 4 actuations of Ventolin HFA, defined as a post-Ventolin HFA increase in FEV1 at 30 minutes of ≥ 12% and ≥ 200 mL at either Visit 1, Visit 1a, or Visit 1b; only 2 reversibility testing attempts are allowed.
• Demonstrate acceptable spirometry performance (ie, meet ATS/ERS acceptability/repeatability criteria).
• Willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol.
• Demonstrate acceptable MDI administration technique. Note: Use of a spacer device during the screening and randomized treatment periods is not permitted.
• Weight
• Body mass index \< 40 kg/m2. Sex and Contraceptive/Barrier Requirements
• Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions and History
• Any evidence of chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.
• Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within the last 5 years.
• Upper respiratory infection not resolved within 7 days of Visit 1 and throughout the screening period.
• Hospitalizations for asthma exacerbation within the last 3 months prior to Visit 1.
• Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, participants with known QTcF ≥ 480 ms, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation, or that could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
• Cancer not in complete remission for at least 5 years prior to Visit 1. Note: Participants with squamous cell carcinoma of the skin or basal cell carcinoma of the skin or cervical carcinoma in situ are eligible, if in the opinion of the investigator, the condition has been adequately worked up and clinically controlled, and the participant's participation in the study would not represent a safety concern.
• Hospitalized for psychiatric disorder or attempted suicide within one year prior to Visit 1.
• History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions limiting informed consent validity.
• Received a live attenuated vaccination within 7 days of Visit 1. Prior/Concomitant Therapy
• Oral/systemic corticosteroid use (any dose) within 6 weeks of Visit 1.
• Chronic use of oral corticosteroids (≥ 3 weeks use in the 3 months prior to Visit 1).
• Received tiotropium within 2 weeks of Visit 1.
• Received treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (22)

Research Site

Encinitas, California, 92024, United States

Location

Research Site

Lancaster, California, 93534, United States

Location

Research Site

Los Angeles, California, 90048, United States

Location

Research Site

Newport Beach, California, 92663, United States

Location

Research Site

San Diego, California, 92123, United States

Location

Research Site

San Jose, California, 95117, United States

Location

Research Site

Stockton, California, 95207, United States

Location

Research Site

Clearwater, Florida, 33765, United States

Location

Research Site

Miami, Florida, 33175, United States

Location

Research Site

Tallahassee, Florida, 32308, United States

Location

Research Site

Tampa, Florida, 33607, United States

Location

Research Site

White Marsh, Maryland, 21162, United States

Location

Research Site

Columbia, Missouri, 65203, United States

Location

Research Site

Saint Charles, Missouri, 63301, United States

Location

Research Site

St Louis, Missouri, 63141, United States

Location

Research Site

Raleigh, North Carolina, 27607, United States

Location

Research Site

Medford, Oregon, 97504, United States

Location

Research Site

Portland, Oregon, 97202, United States

Location

Research Site

Austin, Texas, 78759, United States

Location

Research Site

El Paso, Texas, 79912, United States

Location

Research Site

Victoria, Texas, 77901, United States

Location

Research Site

Milwaukee, Wisconsin, 53228, United States

Location

MeSH Terms

Conditions

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity

Interventions

Methods

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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."
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 16, 2024
• Study Start: February 10, 2025
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Phrma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (22)