Study identifier:D6930C00001
ClinicalTrials.gov identifier:NCT03364608
EudraCT identifier:N/A
CTIS identifier:N/A
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)
asthma
Phase 2
No
AS MDI 90 μg, AS MDI 180 µg, Proventil 90 μg, Proventil 180 μg
All
86
Interventional
12 Years - 65 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jul 2019 by AstraZeneca
AstraZeneca
-
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.
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.
Location
Location
Winter Park, FL, United States, 32789
Location
Medford, OR, United States, 97504
Location
St. Louis, MO, United States, 63141
Location
Raleigh, NC, United States, 27607
Location
North Dartmouth, MA, United States, 02747
Location
Rolling Hills Estate, CA, United States, 90274
Location
Stockton, CA, United States, 95207
Location
Spartanburg, SC, United States, 29303
Arms | Assigned Interventions |
---|---|
Experimental: • AS MDI 90 µg (2 actuations of 45 µg/actuation) | Drug: AS MDI 90 μg AS MDI 90 μg (2 actuations of 45 μg/actuation) Other Name: AS MDI |
Experimental: • AS MDI 180 µg (2 actuations of 90 µg/actuation) | Drug: AS MDI 180 µg AS MDI 180 μg (2 actuations of 90 μg/actuation) Other Name: AS MDI |
Placebo Comparator: • Placebo MDI (2 actuations) | Other: Placebo MDI Placebo MDI (2 actuations) Other Name: Placebo MDI |
Active Comparator: • Proventil 90 µg (1 actuation of 90 µg/actuation) | Drug: Proventil 90 μg Proventil 90 μg (1 actuation of 90 μg/actuation) Other Name: Proventil |
Active Comparator: • Proventil 180 µg (2 actuations of 90 µg/actuation) | Drug: Proventil 180 μg Proventil 180 μg (2 actuations of 90 μg/actuation) Other Name: Proventil |
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
---|
This study was conducted at 10 sites in the United States, from December 2017 to March 2018. The study was anticipated to run for at least 23 days but not to exceed 68 days. |
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
---|
Subjects were randomized into one of 10 treatment sequences. Each sequence comprised all 5 treatments included in this study (ie, AS MDI 90 μg, AS MDI 180 μg, Placebo MDI, Proventil 90 μg, and Proventil 180 μg) in a randomized order |
Description | |
---|---|
Subjects | ITT Analysis set |
Subjects | |
---|---|
STARTED | 86 |
Placebo MDI | 82 |
AS MDI 90 µg | 81 |
AS MDI 180 µg | 81 |
Proventil 90 µg | 82 |
Proventil 180 µg | 79 |
COMPLETED | 78 |
NOT COMPLETED | 8 |
Withdrawal by Subject | 4 |
Protocol Violation | 2 |
Lost to Follow-up | 2 |
Description | |
---|---|
Overall Study | Safety Set |
Overall Study | |
---|---|
Number of Participants
[units: Participants] |
86 |
Age Continuous [units: Years] Mean ± Standard Deviation |
42.7 ± 13.4 |
Sex: Female, Male [units: Participants] |
|
Female | 47 |
Male | 39 |
Race (NIH/OMB) [units: ] |
|
American Indian or Alaska Native | 0 |
Asian | 1 |
Native Hawaiian or Other Pacific Islander | 0 |
Black or African American | 20 |
White | 62 |
More than one race | 0 |
Unknown or Not Reported | 3 |
Ethnicity (NIH/OMB) [units: ] |
|
Hispanic or Latino | 14 |
Not Hispanic or Latino | 72 |
Unknown or Not Reported | 0 |
Measure Type | Primary |
---|---|
Measure Name | Change from baseline in FEV1 AUC0-6 |
Measure Description | 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. |
Time Frame | Over 6 hours post dose on Day 1 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
mITT Population |
Description | |
---|---|
AS MDI 180 µg | (2 actuations of 90 µg/actuation) |
AS MDI 90 µg | (2 actuations of 45 µg/actuation) |
Proventil 180 µg | (2 actuations of 90 µg/actuation) |
Proventil 90 µg | (1 actuation of 90 µg/actuation) |
Placebo MDI | (2 actuations) |
AS MDI 180 µg | AS MDI 90 µg | Proventil 180 µg | Proventil 90 µg | Placebo MDI | |
---|---|---|---|---|---|
Number of
Participants Analyzed [units:participants] |
79 | 79 | 77 | 78 | 78 |
Change from baseline in FEV1 AUC0-6 [units: Liters] Least Squares Mean (95% Confidence Interval) |
0.266 (0.219 to 0.313) | 0.203 (0.156 to 0.251) | 0.282 (0.234 to 0.329) | 0.240 (0.193 to 0.288) | 0.070 (0.022 to 0.117) |
Measure Type | Secondary |
---|---|
Measure Name | Change from baseline in FEV1 AUC0-4 |
Measure Description | 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. |
Time Frame | Over 4 hours post dose on Day 1 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
mITT Population |
Description | |
---|---|
AS MDI 180 µg | (2 actuations of 90 µg/actuation) |
AS MDI 90 µg | (2 actuations of 45 µg/actuation) |
Proventil 180 µg | (2 actuations of 90 µg/actuation) |
Proventil 90 µg | (1 actuation of 90 µg/actuation) |
Placebo MDI | (2 actuations) |
AS MDI 180 µg | AS MDI 90 µg | Proventil 180 µg | Proventil 90 µg | Placebo MDI | |
---|---|---|---|---|---|
Number of
Participants Analyzed [units:participants] |
79 | 79 | 77 | 78 | 78 |
Change from baseline in FEV1 AUC0-4 [units: Liters] Least Squares Mean (95% Confidence Interval) |
0.331 (0.280 to 0.381) | 0.263 (0.213 to 0.313) | 0.349 (0.299 to 0.400) | 0.297 (0.247 to 0.348) | 0.080 (0.030 to 0.131) |
Measure Type | Secondary |
---|---|
Measure Name | Peak Change from Baseline in FEV1 |
Measure Description | Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second) |
Time Frame | Over 6 hours post dose on Day 1 |
Safety Issue? | No |
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
---|
mITT Population |
Description | |
---|---|
AS MDI 180 µg | (2 actuations of 90 µg/actuation) |
AS MDI 90 µg | (2 actuations of 45 µg/actuation) |
Proventil 180 µg | (2 actuations of 90 µg/actuation) |
Proventil 90 µg | (1 actuation of 90 µg/actuation) |
Placebo MDI | (2 actuations) |
AS MDI 180 µg | AS MDI 90 µg | Proventil 180 µg | Proventil 90 µg | Placebo MDI | |
---|---|---|---|---|---|
Number of
Participants Analyzed [units:participants] |
79 | 79 | 77 | 78 | 78 |
Peak Change from Baseline in FEV1 [units: Liters] Least Squares Mean (95% Confidence Interval) |
0.509 (0.451 to 0.567) | 0.433 (0.375 to 0.491) | 0.516 (0.458 to 0.574) | 0.472 (0.414 to 0.530) | 0.233 (0.176 to 0.291) |
Time Frame | Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug |
---|---|
Additional Description | Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 68 days, which includes screening and follow up (3-7 days after last dose of study drug). |
Description | |
---|---|
Placebo MDI | (2 actuations) |
AS MDI 90 µg | (2 actuations of 45 µg/actuation) |
Proventil 180 µg | (2 actuations of 90 µg/actuation) |
Proventil 90 µg | (1 actuation of 90 µg/actuation) |
• Proventil 180 µg | (2 actuations of 90 µg/actuation) |
Placebo MDI | AS MDI 90 µg | Proventil 180 µg | Proventil 90 µg | • Proventil 180 µg | |
---|---|---|---|---|---|
Total, serious adverse events | |||||
# participants affected / at risk | 0/82 (0.00%) | 0/81 (0.00%) | 0/81 (0.00%) | 0/82 (0.00%) | 0/79 (0.00%) |
Time Frame | Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug |
---|---|
Additional Description | Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 68 days, which includes screening and follow up (3-7 days after last dose of study drug). |
Threshold above which other adverse events are reported | 2% |
---|
Description | |
---|---|
Placebo MDI | (2 actuations) |
AS MDI 90 µg | (2 actuations of 45 µg/actuation) |
Proventil 180 µg | (2 actuations of 90 µg/actuation) |
Proventil 90 µg | (1 actuation of 90 µg/actuation) |
• Proventil 180 µg | (2 actuations of 90 µg/actuation) |
Placebo MDI | AS MDI 90 µg | Proventil 180 µg | Proventil 90 µg | • Proventil 180 µg | |
---|---|---|---|---|---|
Total, other (not including serious) adverse events | |||||
# participants affected / at risk | 0/82 (0.00%) | 0/81 (0.00%) | 0/81 (0.00%) | 0/82 (0.00%) | 0/79 (0.00%) |
Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
---|
No text entered. |
Name/Title: | Colin Reisner, MD FCCP, FAAAAI |
Organization: | Pearl Therapeutics, Inc, a Member of the AstraZeneca Group |
Phone | 9739750321 |
E-mail: | [email protected] |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.