PT027 compared to PT007 in patients with asthma with mannitol-induced acute airway obstruction

Study identifier:D6930C00017

ClinicalTrials.gov identifier:NCT05555290

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

ALTA - ALbuterol/budesonide Treatment in Acute airway obstruction. A randomized, double-blind, 2-period, cross-over study evaluating efficacy and safety of repeated doses of PT027 compared to PT007 in patients with asthma and acute airway obstruction induced by repeated mannitol challenges

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

Sex

All

Estimated Enrollment

105

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 28 Sept 2022

Estimated Primary Completion Date: 05 Nov 2024

Estimated Study Completion Date: 05 Nov 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Participants who have been diagnosed with asthma > 6 months before Visit 1 by a physician.
- Participants must have been prescribed and using as-needed SABA as only asthma treatment for at least 4 weeks before screening visit.
- Participants should have pre-bronchodilator FEV1 ≥ 1.5 L and FEV1 ≥ 60% to < 90% predicted normal at Visit 1.
- Participants should have a positive response to mannitol challenge performed at Visit 1 (a decrease in FEV1 by at least 15% [PD15] at ≤ 635 mg).
- Participants should return to within 10% of baseline FEV1 (≥ 90% of baseline FEV1), within 1 hour after positive mannitol challenge and 4 inhalations of PT007, performed at Visit 1.
- Participants should be able to adhere to study procedures in the judgment of the Investigator.
- Male or female.
- Women of childbearing potential must have a negative urine pregnancy test at each study visit.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.

Exclusion Criteria

- Any evidence of clinically significant lung disease other than asthma.
- If the participant has had any face-to-face unscheduled or urgent visit for asthma
worsening within the last 4 weeks.
- Any significant disease or disorder, or evidence of drug/substance abuse which in the Investigator’s opinion would pose a risk to participant safety, interfere with the conduct of study, have an impact on the study results, or make it undesirable for the participant to participate in the study.
- If participants have used Inhaled corticosteroids (ICS) within 1 month prior to enrolment.
- If they have used immunosuppressive medication (including but not limited to methotrexate, troleandomycin, cyclosporine, azathioprine, systemic corticosteroids including regular treatment with oral corticosteroids or intramuscular long-acting depot corticosteroids, or any experimental anti-inflammatory therapy) within 3 months prior to enrolment (Visit 1) or plan on starting immunosuppressive medications during the study.
- If they have used allergen-specific immunotherapy (desensitization) within 3 months prior to enrolment.
- If they have used systemic corticosteroids (including oral and injected) within 3 months prior to enrolment.
- If they have received any marketed or investigational biologic within 4 months or 5 half-lives prior to enrolment (whichever is longer) or received any investigational nonbiologic agent within 30 days or 5 half-lives prior to enrolment (whichever is longer).
- Participants with a known hypersensitivity to beta2-agonists, ICS, mannitol, or any of the excipients of the product.
- Any clinically significant abnormal findings in physical examination, vital signs, ECG (eg, participants with QTcF > 500 ms), hematology, clinical chemistry, or urinalysis, which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant’s ability to complete entire duration of the study.
- If they are current smokers or participants with smoking history ≥ 10 pack years including the use of vaping products, such as electronic cigarettes, and water pipes. If they are former smokers with a smoking history of <10 pack years, including former vaping or water pipe users, smoking must have stopped for at least 6 months prior to Visit 1 to be eligible.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and its affiliates and/or staff at the study site and their immediate relative(s)).
- Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- Breast feeding, pregnancy or intention to become pregnant during the course of the study.
- Previous randomization in the present study.

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Arms	Assigned Interventions
Experimental: Treatment A (PT027) [experimental], then Treatment B (PT007) [active comparator] Part 1 & 2 At Visit 2, participants will receive repeated oral inhalations of PT027 to treat acute airway obstruction induced by a repeated airway challenge, followed by a washout period of 10-14 days. At Visit 3, participants will receive repeated oral inhalations of PT007 to treat acute airway obstruction induced by a repeated airway challenge.	Combination Product: PT027 When administered PT027, participants will receive 2 actuations of albuterol- budesonide per dose administered as oral inhalations. Combination Product: PT007 When administered PT007, participants will receive 2 actuations of albuterol administered as oral inhalations.
Experimental: Treatment B (PT007) [active comparator], then Treatment A (PT027) [experimental] Part 1 & 2 At Visit 2, participants will receive repeated oral inhalations of PT007 to treat acute airway obstruction induced by a repeated airway challenge, followed by a washout period of 10 to 14 days. At Visit 3, participants will receive repeated oral inhalations of PT027 to treat acute airway obstruction induced by a repeated airway challenge.	Combination Product: PT027 When administered PT027, participants will receive 2 actuations of albuterol- budesonide per dose administered as oral inhalations. Combination Product: PT007 When administered PT007, participants will receive 2 actuations of albuterol administered as oral inhalations.

Arms

Assigned Interventions

Experimental: Treatment A (PT027) [experimental], then Treatment B (PT007) [active comparator] Part 1 & 2
At Visit 2, participants will receive repeated oral inhalations of PT027 to treat acute airway obstruction induced by a repeated airway challenge, followed by a washout period of 10-14 days. At Visit 3, participants will receive repeated oral inhalations of PT007 to treat acute airway obstruction induced by a repeated airway challenge.

Combination Product: PT027
When administered PT027, participants will receive 2 actuations of albuterol- budesonide per dose administered as oral inhalations.

Combination Product: PT007
When administered PT007, participants will receive 2 actuations of albuterol administered as oral inhalations.

Experimental: Treatment B (PT007) [active comparator], then Treatment A (PT027) [experimental] Part 1 & 2
At Visit 2, participants will receive repeated oral inhalations of PT007 to treat acute airway obstruction induced by a repeated airway challenge, followed by a washout period of 10 to 14 days. At Visit 3, participants will receive repeated oral inhalations of PT027 to treat acute airway obstruction induced by a repeated airway challenge.