AsthmaPhase 2MITCHELLNCT06644924
A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With Asthma
A Phase 2 study testing Intervention: AS MDI and Intervention: Ventolin Evohaler in people with Asthma, run by AstraZeneca at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Intervention: AS MDI and Intervention: Ventolin Evohaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 22 sitesUnited States
- Study dates
- 10 Feb 2025to 4 Jun 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Female participants: A participant of childbearing potential, must have a negative urine pregnancy test at Visit 1 (to be read locally).
- Participants not of childbearing potential are defined as those who are physiologically incapable of becoming pregnant, including any participant who is 2 years postmenopausal, or surgically sterile (defined as having a bilateral oophorectomy, hysterectomy, tubal ligation, or other permanent birth control measures).
- Participants aged ≥ 50 years will be considered postmenopausal if they have been amenorrheic for 12 consecutive months or more following cessation of all exogenous hormonal treatment.
- Participants aged < 50 years will be considered postmenopausal if they have been amenorrheic for 12 consecutive months or more following cessation of exogenous hormonal treatment and in the absence of any alternative medical cause, as judged by the investigator.
- 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:
- Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation):
- Oral
- Intravaginal (eg, NuvaRing®)
- Transdermal (eg, Evra Patch™, Xulane™)
- Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral
- Injectable (eg, Depo-Provera™)
- 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.
- Note: Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), declaration of abstinence for the duration of exposure to study intervention, spermicides only, and lactational amenorrhea method are not acceptable methods of contraception.
- Informed Consent
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Other Inclusion Criteria
- Compliance: must be willing to remain at the study site as required per protocol to complete all visit assessments.
Who cannot join
- 5.2 Exclusion Criteria
- 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.
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- 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 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.
- Received tiotropium within 2 weeks of Visit 1.
- Received treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1.
- Unable to abstain from protocol-defined prohibited medications during screening and the study.
- Using any herbal products by inhalation or nebulizer within 2 weeks of Visit 1 and does not agree to stop during the study duration.
- Prior/Concurrent Clinical Study Experience
- 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.
- Hypersensitivity to β2-agonists or any component of the investigational MDI or any component of Ventolin Evohaler or HFA (or Pulmicort Flexhaler, if applicable).
- Other Exclusions
- Significant abuse of alcohol or drugs in the opinion of the investigator.
- 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).
- Study investigators, sub-investigators, coordinators, and their employees or immediate family members, or employees of the sponsor.
- 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.
- For female participants only: currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Research Site
Austin, Texas, 78759
Research Site
Clearwater, Florida, 33765
Research Site
Columbia, Missouri, 65203
Research Site
El Paso, Texas, 79912
Research Site
Encinitas, California, 92024
Research Site
Lancaster, California, 93534
Research Site
Los Angeles, California, 90048
Research Site
Medford, Oregon, 97504
Research Site
Miami, Florida, 33175
Research Site
Milwaukee, Wisconsin, 53228
Research Site
Newport Beach, California, 92663
Research Site
Portland, Oregon, 97202
Research Site
Raleigh, North Carolina, 27607
Research Site
Saint Charles, Missouri, 63301
Research Site
San Diego, California, 92123
Research Site
San Jose, California, 95117
Research Site
St Louis, Missouri, 63141
Research Site
Stockton, California, 95207
Research Site
Tallahassee, Florida, 32308
Research Site
Tampa, Florida, 33607
Research Site
Victoria, Texas, 77901
Research Site
White Marsh, Maryland, 21162
About this study
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
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.
Read the 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% 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
- Asthma
- Being tested
- Intervention: AS MDI, Intervention: Ventolin Evohaler, Intervention: Placebo matching AS MDI
- Keywords
- Asthma, Bronchial, Bronchial Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Respiratory Hypersensitivity, Anti-Asthmatic Agents, Respiratory System Agents
- Medical subject headings
- Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: AS MDICombination product
Also called Albuterol Sulfate metered dose inhaler [AS MDI] - PT007)
Drug Treatment: (Albuterol Sulfate metered dose inhaler [AS MDI] - PT007) Randomized participants will receive a single-dose (2 inhalations)
Intervention: Ventolin EvohalerCombination product
Drug: Treatment (Ventolin Evohaler) Randomized participants will receive a single-dose (2 inhalations)
Intervention: Placebo matching AS MDICombination product
Drug: Treatment (Placebo MDI) Randomized participants will receive a single-dose (2 inhalations to match AS MDI)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Combination Product: Intervention: AS MDI; Combination Product: Intervention: Ventolin Evohaler; Combination Product: Intervention: Placebo matching AS MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. Area Under the Curve (AUC) 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., ~ 6 hours).
Measured: 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)
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
Change from baseline in FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., ~ 6 hours).
Measured: 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 (7)
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., ~ 6 hours).
Measured: 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)
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., ~ 4 hours).
Measured: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
Change from baseline FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., ~ 4 hours).
Measured: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., ~ 4 hours).
Measured: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values.
Measured: 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)
Peak Change From Baseline in FEV1 (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values.
Measured: 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)
Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start10 Feb 2025
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644924
- Sponsor's protocol ID
- D6935C00002
- Acronym
- MITCHELL
- Status last verified
- Jul 2026
- First submitted
- 15 Oct 2024
- Last updated
- 27 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.