Inhaled PT007 for Asthma
(MITCHELL Trial)
Recruiting in Palo Alto (17 mi)
+22 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AstraZeneca
Must be taking: SABA, ICS, LABA
Must not be taking: Oral corticosteroids, Biologics, Tiotropium, others
Disqualifiers: COPD, Life-threatening asthma, Cancer, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does require that you are willing to adjust your asthma therapy as needed. Some medications, like oral corticosteroids and certain biologics, must be stopped before joining the study.
What data supports the effectiveness of the drug PT007 (AS MDI) for asthma?
Research shows that metered-dose inhalers (MDIs), like PT007, are effective in delivering asthma medication, and proper technique is crucial for achieving good results. Additionally, similar treatments using inhalers with fluticasone propionate and salmeterol have been shown to be effective for asthma.12345
What safety data exists for inhaled PT007 for asthma?
How is the drug PT007 (AS MDI) different from other asthma treatments?
Research Team
Eligibility Criteria
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.Inclusion Criteria
My lung function improved by at least 12% after using Ventolin HFA.
Demonstrate acceptable MDI administration technique. Note: Use of a spacer device during the screening and randomized treatment periods is not permitted.
I can sign and follow the study's consent form and rules.
See 11 more
Exclusion Criteria
I have been hospitalized for asthma in the last 3 months.
I have not been hospitalized for psychiatric reasons or attempted suicide in the last year.
My cold or flu symptoms lasted more than 7 days.
See 20 more
Trial Timeline
Screening/Run-in
Participants are screened for eligibility to participate in the trial
3 to 28 days
1 visit (in-person)
Treatment
Participants receive a single dose of randomized study intervention at each of 3 treatment visits, with a 3- to 7-day washout period between treatment visits
9 to 17 days
3 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment via a follow-up phone call
3 to 7 days after the final dose
1 visit (phone call)
Treatment Details
Interventions
- PT007(AS MDI) (Combination Product)
Trial OverviewThe 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.
Participant Groups
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
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).
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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteMiami, FL
Research SiteRaleigh, NC
Research SiteWhite Marsh, MD
Research SiteEncinitas, CA
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Trials
4491
Patients Recruited
290,540,000+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Fluticasone propionate and fluticasone propionate/salmeterol multidose dry powder inhalers compared with placebo for persistent asthma.Sher, LD., Yiu, G., Sakov, A., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Nebulized wet aerosol treatment in emergency department--is it essential? Comparison with large spacer device for metered-dose inhaler.Mandelberg, A., Chen, E., Noviski, N., et al.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Randomized dose-ranging study of a budesonide metered-dose inhaler by using co-suspension delivery technology in asthma.Miller, SD., Nyberg, J., Siddiqui, S., et al.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Randomized, double-blind trial evaluating the efficacy and safety of fluticasone propionate and fluticasone propionate/salmeterol delivered via multidose dry powder inhalers in patients with persistent asthma aged 12 years and older.Raphael, G., Yiu, G., Sakov, A., et al.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Metered-dose inhaler technique and quality of life with airways disease: assessing the value of the Vitalograph in educational intervention.Skaer, TL., Wilson, CB., Sclar, DA., et al.[2017]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma.Raphael, G., Taveras, H., Iverson, H., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Advances in metered dose inhaler technology with the development of a chlorofluorocarbon-free drug delivery system.Ross, DL., Gabrio, BJ.[2005]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD.Weinstein, C., Staudinger, H., Scott, I., et al.[2015]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Easyhaler, a novel multiple dose powder inhaler: clinically equivalent to salbutamol metered dose inhaler and easier to use.Nieminen, MM., Vidgren, M., Laurikainen, K., et al.[2018]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Superiority of nebulized corticosteroids over dry powder inhalers in certain patients with cough variant asthma or cough-predominant asthma.Kamimura, M., Izumi, S., Hamamoto, Y., et al.[2012]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
[Errors in the technique of using measured-dose inhalers in asthmatic children and adolescents].de la Rosa López, JH., González Díaz, SN., Canseco González, C., et al.[2015]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Clinical equivalence of a novel multiple dose powder inhaler versus a conventional metered dose inhaler on bronchodilating effects of salbutamol.Vidgren, M., Silvasti, M., Korhonen, P., et al.[2013]
References
Fluticasone propionate and fluticasone propionate/salmeterol multidose dry powder inhalers compared with placebo for persistent asthma. [2018]
Nebulized wet aerosol treatment in emergency department--is it essential? Comparison with large spacer device for metered-dose inhaler. [2019]
Randomized dose-ranging study of a budesonide metered-dose inhaler by using co-suspension delivery technology in asthma. [2019]
Randomized, double-blind trial evaluating the efficacy and safety of fluticasone propionate and fluticasone propionate/salmeterol delivered via multidose dry powder inhalers in patients with persistent asthma aged 12 years and older. [2019]
Metered-dose inhaler technique and quality of life with airways disease: assessing the value of the Vitalograph in educational intervention. [2017]
Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma. [2018]
Advances in metered dose inhaler technology with the development of a chlorofluorocarbon-free drug delivery system. [2005]
Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD. [2015]
Easyhaler, a novel multiple dose powder inhaler: clinically equivalent to salbutamol metered dose inhaler and easier to use. [2018]
Superiority of nebulized corticosteroids over dry powder inhalers in certain patients with cough variant asthma or cough-predominant asthma. [2012]
[Errors in the technique of using measured-dose inhalers in asthmatic children and adolescents]. [2015]
Clinical equivalence of a novel multiple dose powder inhaler versus a conventional metered dose inhaler on bronchodilating effects of salbutamol. [2013]