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Combination Product

Inhaled PT007 for Asthma (MITCHELL Trial)

Phase 2

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed FEV1 reversibility to 4 actuations of Ventolin HFA, defined as a post-Ventolin HFA increase in FEV1 of ≥ 12% at either Visit 1, Visit 1a, or Visit 1b; only 2 reversibility testing attempts are allowed.

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).

Must not have

Hospitalizations for asthma exacerbation within the last 3 months prior to Visit 1.

Hospitalized for psychiatric disorder or attempted suicide within one year prior to Visit 1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization throughout the treatment period and including the follow-up period (telephone contact).

Summary

"This trial will test the effectiveness and safety of inhaled PT007 in treating asthma compared to a placebo and another asthma medication. The study will involve male and female participants aged 18 to 65 and

Who is the study for?

This trial is for adults aged 18 to 65 with asthma. Specific details about who can join or reasons why someone might not be able to participate are not provided.

What is being tested?

The study tests the effectiveness and safety of a new inhaled medication, PT007 (AS MDI), against a placebo inhaler and Ventolin Evohaler. It's a Phase II trial involving screening, treatment period, and follow-up call.

What are the potential side effects?

Potential side effects are not listed but may include typical reactions to inhaled asthma medications such as throat irritation, coughing, or an increased heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung function improved by at least 12% after using Ventolin HFA.

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My lung function is at least 40% of the predicted normal value.

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I am between 18 and 65 years old.

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I have been using asthma inhalers for the last 30 days as my main treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been hospitalized for asthma in the last 3 months.

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I have not been hospitalized for psychiatric reasons or attempted suicide in the last year.

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I have taken tiotropium in the last 2 weeks.

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I can avoid taking certain medications during the study.

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I have a chronic lung condition like COPD.

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I have had severe asthma attacks in the past 5 years.

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My cancer has not been in complete remission for 5 years.

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I have not received a live vaccine in the week before my first visit.

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I have been taking oral corticosteroids regularly for the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 4 hours (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in FEV1 AUC 0-6 hours

Secondary study objectives

Change from baseline in FEV1 AUC 0 - 4

Peak Change From Baseline in FEV1

Other study objectives

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Treatment Sequence 6Experimental Treatment3 Interventions

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).

Group II: Treatment Sequence 5Experimental Treatment3 Interventions

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).

Group III: Treatment Sequence 4Experimental Treatment3 Interventions

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).

Group IV: Treatment Sequence 3Experimental Treatment3 Interventions

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).

Group V: Treatment Sequence 2Experimental Treatment3 Interventions

Group VI: Treatment Sequence 1Experimental Treatment3 Interventions

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).

0 / 13Eligibility criteria met