AsthmaPhase 2NCT03364608
Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
A Phase 2 study testing AS MDI 90 μg, AS MDI 180 µg and Proventil 90 μg in people with Asthma, run by AstraZeneca at 10 sites in United States.
Trial summary
This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo… Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- AS MDI 90 μg, AS MDI 180 µg and Proventil 90 μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Dec 2017to 30 Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Are at least 12 years of age and no older than 65 years
- Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis
- Must be receiving 1 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, or Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy
- Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society [ATS]/European Respiratory Society [ERS] acceptability/repeatability criteria
- Pre-bronchodilator FEV1 of ≥40 to <90% predicted normal value after withholding SABA for ≥6 hours
- Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1 of ≥15%
- only 2 reversibility testing attempts are allowed
Who cannot join
- Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
- Oral corticosteroid use (any dose) within 6 weeks
- 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)
- Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
- Historical or current evidence of a clinically significant disease
- Cancer not in complete remission for at least 5 years
- Hospitalized for psychiatric disorder or attempted suicide within 1 year
- Unable to abstain from protocol-defined prohibited medications during the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Research Site
Cincinnati, Ohio, 45242
Research Site
El Paso, Texas, 79903
Research Site
Medford, Oregon, 97504
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Raleigh, North Carolina, 27607
Research Site
Rolling Hills Estates, California, 90274
Research Site
Spartanburg, South Carolina, 29303
Research Site
St Louis, Missouri, 63141
Research Site
Stockton, California, 95207
Research Site
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Double-blind, Single Dose, Placebo-controlled, 5-Period, 5-Treatment, Crossover, Multi-center, Dose-ranging Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Mild to Moderate Asthma (ANTORA)
This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.
Read the detailed description
This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.
- Conditions
- Asthma
- Being tested
- AS MDI 90 μg, AS MDI 180 µg, Placebo MDI, Proventil 90 μg, Proventil 180 μg
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS MDI 90 μgDrug
Also called AS MDI
AS MDI 90 μg (2 actuations of 45 μg/actuation)
AS MDI 180 µgDrug
Also called AS MDI
AS MDI 180 μg (2 actuations of 90 μg/actuation)
Placebo MDIOther
Placebo MDI (2 actuations)
Proventil 90 μgDrug
Also called Proventil
Proventil 90 μg (1 actuation of 90 μg/actuation)
Proventil 180 μgDrug
Also called Proventil
Proventil 180 μg (2 actuations of 90 μg/actuation)
| Study group | Role | What they receive |
|---|---|---|
| • AS MDI 90 µg | Experimental | (2 actuations of 45 µg/actuation) Receives: Drug: AS MDI 90 μg |
| • AS MDI 180 µg | Experimental | (2 actuations of 90 µg/actuation) Receives: Drug: AS MDI 180 µg |
| • Placebo MDI | Placebo comparator | (2 actuations) Receives: Other: Placebo MDI |
| • Proventil 90 µg | Active comparator | (1 actuation of 90 µg/actuation) Receives: Drug: Proventil 90 μg |
| • Proventil 180 µg | Active comparator | (2 actuations of 90 µg/actuation) Receives: Drug: Proventil 180 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in FEV1 AUC0-6
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.
Measured: Over 6 hours post dose on Day 1
Secondary outcomes (2)
Change From Baseline in FEV1 AUC0-4
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up.
Measured: Over 4 hours post dose on Day 1
Peak Change From Baseline in FEV1
Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)
Measured: Over 6 hours post dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start15 Dec 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364608
- Sponsor's protocol ID
- D6930C00001
- Status last verified
- Jul 2019
- First submitted
- 1 Dec 2017
- Last updated
- 24 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cappelletti C, Maes A, Rossman K, Gillen M, LaForce C, Kerwin EM, Reisner C. Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA Trials. Clin Drug Investig. 2021 Jun;41(6):579-590. doi: 10.1007/s40261-021-01040-7. Epub 2021 Jun 4.
PubMed 34089147
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single Dose, Placebo-controlled, 5-Period, 5-Treatment, Crossover, Multi-center, Dose-ranging Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Mild to Moderate Asthma (ANTORA)
- ClinicalTrials.gov ID
- NCT03364608
- Acronym / sponsor ID
- D6930C00001
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.
Detailed description
This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| • AS MDI 90 µg | Experimental | Drug: AS MDI 90 μg(2 actuations of 45 µg/actuation) |
| • AS MDI 180 µg | Experimental | Drug: AS MDI 180 µg(2 actuations of 90 µg/actuation) |
| • Placebo MDI | Placebo comparator | Other: Placebo MDI(2 actuations) |
| • Proventil 90 µg | Active comparator | Drug: Proventil 90 μg(1 actuation of 90 µg/actuation) |
| • Proventil 180 µg | Active comparator | Drug: Proventil 180 μg(2 actuations of 90 µg/actuation) |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Are at least 12 years of age and no older than 65 years
- Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis
- Must be receiving 1 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, or Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy
- Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society [ATS]/European Respiratory Society [ERS] acceptability/repeatability criteria
- Pre-bronchodilator FEV1 of ≥40 to <90% predicted normal value after withholding SABA for ≥6 hours
Key exclusion criteria (8 listed)
- Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
- Oral corticosteroid use (any dose) within 6 weeks
- 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)
- Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
- Historical or current evidence of a clinically significant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AS MDI 90 μgAlso: AS MDIAS MDI 90 μg (2 actuations of 45 μg/actuation) | Drug | • AS MDI 90 µg |
| AS MDI 180 µgAlso: AS MDIAS MDI 180 μg (2 actuations of 90 μg/actuation) | Drug | • AS MDI 180 µg |
| Placebo MDIPlacebo MDI (2 actuations) | Other | • Placebo MDI |
| Proventil 90 μgAlso: ProventilProventil 90 μg (1 actuation of 90 μg/actuation) | Drug | • Proventil 90 µg |
| Proventil 180 μgAlso: ProventilProventil 180 μg (2 actuations of 90 μg/actuation) | Drug | • Proventil 180 µg |
Primary outcome
Change From Baseline in FEV1 AUC0-6
Time frame: Over 6 hours post dose on Day 1
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.
2 secondary outcomes
Change From Baseline in FEV1 AUC0-4
Time frame: Over 4 hours post dose on Day 1
Peak Change From Baseline in FEV1
Time frame: Over 6 hours post dose on Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34089147Cappelletti C, Maes A, Rossman K, Gillen M, LaForce C, Kerwin EM, Reisner C. Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA Trials. Clin Drug Investig. 2021 Jun;41(6):579-590. doi: 10.1007/s40261-021-01040-7. Epub 2021 Jun 4.
- ProtocolLink provided by the sponsor.
- Statistical Analysis Plan (SAP)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AS MDI 90 μg, AS MDI 180 µg and Proventil 90 μg in people with Asthma, run by AstraZeneca at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in FEV1 AUC0-6 (time frame: Over 6 hours post dose on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.