COMPLETED

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

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Conditions

AsthmaAsthma, BronchialBronchial AsthmaBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityAnti-Asthmatic AgentsRespiratory System Agents

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-02-10
Study Completion:2025-06-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06644924

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participant must be aged 18 to 65 years (inclusive), at the time of signing the informed consent.
  2. 2. Participants should have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1.
  3. 3. Must be receiving one of the following required inhaled asthma therapies listed below for at least the last 30 days:
  4. 1. Only SABA, which is used as needed for rescue.
  5. 2. Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy.
  6. 4. 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).
  7. 5. 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.
  8. 6. Demonstrate acceptable spirometry performance (ie, meet ATS/ERS acceptability/repeatability criteria).
  9. 7. Willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol.
  10. 8. Demonstrate acceptable MDI administration technique. Note: Use of a spacer device during the screening and randomized treatment periods is not permitted.
  11. 9. Body mass index \< 40 kg/m2. Sex and Contraceptive/Barrier Requirements
  12. 10. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  13. 11. Female participants: A participant of childbearing potential, must have a negative urine pregnancy test at Visit 1 (to be read locally).
  14. 12. Participants of childbearing potential must use a highly effective form of contraception from signing of the ICF to 14 days after the last study intervention. Highly effective birth control methods are listed below:
  15. * Oral
  16. * Intravaginal (eg, NuvaRing®)
  17. * Transdermal (eg, Evra Patch™, Xulane™)
  18. * Oral
  19. * Injectable (eg, Depo-Provera™)
  20. * Implantable (eg, Implanon®) Intrauterine device or intrauterine hormone-releasing system Bilateral tubal occlusion Male partner sterilization/vasectomy with documentation of azoospermia prior to the female participant's entry into the study, and this male is the sole partner for that participant. The documentation on male sterility can come from the site personnel's review of participant's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner.
  21. 13. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  22. 14. Compliance: must be willing to remain at the study site as required per protocol to complete all visit assessments.
  1. 5.2 Exclusion Criteria
  2. 1. 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.
  3. 2. 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.
  4. 3. Upper respiratory infection not resolved within 7 days of Visit 1 and throughout the screening period.
  5. 4. Hospitalizations for asthma exacerbation within the last 3 months prior to Visit 1.
  6. 5. 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.
  7. 6. 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.
  8. 7. Hospitalized for psychiatric disorder or attempted suicide within one year prior to Visit 1.
  9. 8. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions limiting informed consent validity.
  10. 9. Received a live attenuated vaccination within 7 days of Visit 1. Prior/Concomitant Therapy
  11. 10. Oral/systemic corticosteroid use (any dose) within 6 weeks of Visit 1.
  12. 11. Chronic use of oral corticosteroids (≥ 3 weeks use in the 3 months prior to Visit 1).
  13. 12. Received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives, whichever is longer, or any other medication specifically prohibited by the protocol within the indicated exclusionary time periods.
  14. 13. Received tiotropium within 2 weeks of Visit 1.
  15. 14. Received treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1.
  16. 15. Unable to abstain from protocol-defined prohibited medications during screening and the study.
  17. 16. Using any herbal products by inhalation or nebulizer within 2 weeks of Visit 1 and does not agree to stop during the study duration.
  18. 17. Treatment with investigational study intervention (or device) in another clinical study within the last 30 days or 5 half-lives, whichever is longer, prior to Visit 1.
  19. 18. Hypersensitivity to β2-agonists or any component of the investigational MDI or any component of Ventolin Evohaler or HFA (or Pulmicort Flexhaler, if applicable).
  20. 19. Significant abuse of alcohol or drugs in the opinion of the investigator.
  21. 20. Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana).
  22. 21. Study investigators, sub-investigators, coordinators, and their employees or immediate family members, or employees of the sponsor.
  23. 22. 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.
  24. 23. For female participants only: currently pregnant (confirmed with positive pregnancy test) or breastfeeding.

Contacts and Locations

Study Locations (Sites)

Research Site
Encinitas, California, 92024
United States
Research Site
Lancaster, California, 93534
United States
Research Site
Los Angeles, California, 90048
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
San Diego, California, 92123
United States
Research Site
San Jose, California, 95117
United States
Research Site
Stockton, California, 95207
United States
Research Site
Clearwater, Florida, 33765
United States
Research Site
Miami, Florida, 33175
United States
Research Site
Tallahassee, Florida, 32308
United States
Research Site
Tampa, Florida, 33607
United States
Research Site
White Marsh, Maryland, 21162
United States
Research Site
Columbia, Missouri, 65203
United States
Research Site
Saint Charles, Missouri, 63301
United States
Research Site
Saint Louis, Missouri, 63141
United States
Research Site
Raleigh, North Carolina, 27607
United States
Research Site
Medford, Oregon, 97504
United States
Research Site
Portland, Oregon, 97202
United States
Research Site
Austin, Texas, 78759
United States
Research Site
El Paso, Texas, 79912
United States
Research Site
Victoria, Texas, 77901
United States
Research Site
Milwaukee, Wisconsin, 53228
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-10
Study Completion Date2025-06-04

Study Record Updates

Study Start Date2025-02-10
Study Completion Date2025-06-04

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Asthma