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A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma

NCT ID: NCT03847896

Last Updated: 2023-04-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1001 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2021-07-20

Brief Summary

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This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of budesonide/albuterol BDA MDI (PT027) to its components budesonide BD MDI (PT008) and albuterol AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BDA MDI (PT027) 160/180 μg

Budesonide/Albuterol sulfate BDA MDI (PT027) high dose

Group Type EXPERIMENTAL

Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)

Intervention Type COMBINATION_PRODUCT

Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)

BDA MDI (PT027) 80/180 μg

Budesonide/Albuterol sulfate BDA MDI (PT027) low dose

Group Type EXPERIMENTAL

Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose)

Intervention Type COMBINATION_PRODUCT

Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)

BD MDI (PT008) 160 µg

Budesonide BD MDI (PT008)

Group Type ACTIVE_COMPARATOR

Budesonide metered dose inhaler / BD MDI 160 µg

Intervention Type DRUG

Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)

AS MDI (PT007) 180 µg

Albuterol sulfate AS MDI (PT007)

Group Type ACTIVE_COMPARATOR

Albuterol sulfate metered dose inhaler / AS MDI 180 μg

Intervention Type DRUG

Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)

Placebo MDI

Placebo MDI

Group Type PLACEBO_COMPARATOR

Placebo metered-dose inhaler / Placebo MDI

Intervention Type OTHER

Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)

Interventions

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Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)

Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 160/180 micrograms (μg), given as 2 inhalations of BDA MDI 80/90 μg, four times a day (QID)

Intervention Type COMBINATION_PRODUCT

Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose)

Budesonide/albuterol sulfate pressurized metered dose inhaler (BDA MDI) 80/180 micrograms (μg), given as 2 inhalations of BDA MDI 40/90 μg, four times a day (QID)

Intervention Type COMBINATION_PRODUCT

Budesonide metered dose inhaler / BD MDI 160 µg

Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)

Intervention Type DRUG

Albuterol sulfate metered dose inhaler / AS MDI 180 μg

Albuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)

Intervention Type DRUG

Placebo metered-dose inhaler / Placebo MDI

Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Female or male aged ≥4 years at the time of informed consent
2. Physician diagnosis of asthma with a documented history of the last 6 months
3. Receiving 1 of the following inhaled asthma medications with stable dosing for at least 30 days prior to Visit 1:

* Only short/rapid-acting β2-adrenoreceptor agonist (SABA) used as needed
* Stable low-dose inhaled corticosteroid in addition to as-needed use of SABA
4. Pre-bronchodilator FEV1 of ≥50 to \<85% predicted normal value for adults (≥18 years of age) and ≥50% predicted normal value for subjects aged 4 to 17 years after withholding SABA ≥6 hours at Visit 1.
5. Demonstrate reversibility of airflow limitation defined as a ≥15% increase in FEV1 relative to baseline after administration of Sponsor-provided SABA (Ventolin) at either Visit 1 or Visit 1a.
6. Demonstrate acceptable spirometry performance acceptability/repeatability criteria
7. Taken Ventolin on ≥2 days out of 7 days prior to Visit 2
8. Demonstrate acceptable metered dose inhaler (MDI) administration technique as assessed by the investigator.
9. Able to perform acceptable and reproducible peak expiratory flow measurements as assessed by the investigator

Exclusion Criteria

1. Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
2. Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
3. Chronic (≥3 weeks) use of SCS within 6 months prior to Visit 1
4. Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication
5. Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months before Visit 1 (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana)
6. Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1
7. Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1
8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1
9. Hospitalizations due to asthma within 6 months prior to Visit 1
10. Have taken ≥12 actuations per day of Sponsor-provided Ventolin during the run-in period prior to Visit 2 according to the below criteria:

* ≥2 days out of 14 days of run-in
* ≥3 days out of 15 to 21 days of run-in
* ≥4 days out of 22 or more days of run-in
11. Unable to comply with study procedures including non-compliance with diary completion (ie, \<70% subject completion of diary assessments in the last 7 days preceding Visit 2 or 4-times daily dosing, \<80% compliance during the placebo run-in period).
12. Historical or current evidence of a clinically significant disease
13. Cancer not in complete remission for at least 5 years before Visit 1
14. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
15. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
16. Significant abuse of alcohol or drugs, in the opinion of the investigator
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bond Avillion 2 Development LP

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Albers, MD, PhD

Role: STUDY_DIRECTOR

Avillion LLP

Locations

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Research Site

Mobile, Alabama, United States

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Bakersfield, California, United States

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Costa Mesa, California, United States

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Encinitas, California, United States

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Huntington Beach, California, United States

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Lancaster, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Jose, California, United States

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Waterbury, Connecticut, United States

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Aventura, Florida, United States

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Clearwater, Florida, United States

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Gainesville, Florida, United States

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Greenacres City, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Oviedo, Florida, United States

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Palmetto Bay, Florida, United States

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Pembroke Pines, Florida, United States

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Pembroke Pines, Florida, United States

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Meridian, Idaho, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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White Marsh, Maryland, United States

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Boston, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Flint, Michigan, United States

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Rochester Hills, Michigan, United States

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Woodbury, Minnesota, United States

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Columbia, Missouri, United States

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Rolla, Missouri, United States

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St Louis, Missouri, United States

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Warrensburg, Missouri, United States

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Missoula, Montana, United States

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Bellevue, Nebraska, United States

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Bellevue, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Skillman, New Jersey, United States

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Toms River, New Jersey, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Monroe, North Carolina, United States

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Raleigh, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Erie, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Gaffney, South Carolina, United States

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Spartanburg, South Carolina, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Boerne, Texas, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sherman, Texas, United States

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Morgantown, West Virginia, United States

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Greenfield, Wisconsin, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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San Miguel de Tucumán, , Argentina

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Santa Fe, , Argentina

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Brandýs nad Labem, , Czechia

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Kralupy nad Vltavou, , Czechia

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Lovosice, , Czechia

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Neratovice, , Czechia

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Prague, , Czechia

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Rokycany, , Czechia

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Varnsdorf, , Czechia

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Darmstadt, , Germany

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Dortmund, , Germany

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Frankfurt, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hessen, , Germany

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Leipzig, , Germany

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Lübeck, , Germany

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Marburg, , Germany

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Munich, , Germany

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Neu-Isenburg, , Germany

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Sachsen, , Germany

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Schleswig, , Germany

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Wiesbaden, , Germany

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Witten, , Germany

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Belgrade, , Serbia

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Kamenitz, , Serbia

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Kragujevac, , Serbia

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Valjevo, , Serbia

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Košice, , Slovakia

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Žilina, , Slovakia

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Cherkasy, , Ukraine

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Dnipro, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kherson, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Lutsk, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhzhya, , Ukraine

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Zaporizhzhya, , Ukraine

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Countries

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United States Argentina Czechia Germany Serbia Slovakia Ukraine

References

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Chipps BE, Israel E, Beasley R, Panettieri RA Jr, Albers FC, Rees R, Dunsire L, Danilewicz A, Johnsson E, Cappelletti C, Papi A. Albuterol-Budesonide Pressurized Metered Dose Inhaler in Patients With Mild-to-Moderate Asthma: Results of the DENALI Double-Blind Randomized Controlled Trial. Chest. 2023 Sep;164(3):585-595. doi: 10.1016/j.chest.2023.03.035. Epub 2023 Mar 30.

Reference Type RESULT
PMID: 37003355 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-003674-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AV004

Identifier Type: -

Identifier Source: org_study_id

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