AsthmaPhase 3DENALINCT03847896

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

A Phase 3 study testing Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose), Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose) and Budesonide metered dose inhaler / BD MDI 160 µg in people with Asthma, run by Bond Avillion 2 Development LP at 129 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 years and older
Conditions the study is for: Asthma
What is being tested?: Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose), Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose) and Budesonide metered dose inhaler / BD MDI 160 µg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,001 participants
Where: 129 sitesin 7 countries
Study dates: 20 Mar 2019to 20 Jul 2021
Phase: Phase 3
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 4 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Female or male aged ≥4 years at the time of informed consent
Physician diagnosis of asthma with a documented history of the last 6 months
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
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.

Show all 11Show fewer

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.
Demonstrate acceptable spirometry performance acceptability/repeatability criteria
Taken Ventolin on ≥2 days out of 7 days prior to Visit 2
Demonstrate acceptable metered dose inhaler (MDI) administration technique as assessed by the investigator.
Able to perform acceptable and reproducible peak expiratory flow measurements as assessed by the investigator

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)
Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
Chronic (≥3 weeks) use of SCS within 6 months prior to Visit 1
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
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)
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

Show all 19Show fewer

Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1
Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1
Hospitalizations due to asthma within 6 months prior to Visit 1
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
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).
Historical or current evidence of a clinically significant disease
Cancer not in complete remission for at least 5 years before Visit 1
Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
Significant abuse of alcohol or drugs, in the opinion of the investigator

Trial locations and contacts

129 sites in 7 countries.

Country

City, postcode or hospital

129 sites in 7 countries

United States73 sites

Research Site
Austin, Texas, 78759
Research Site
Aventura, Florida, 33180
Research Site
Bakersfield, California, 93301
Research Site
Bellevue, Nebraska, 68005
Research Site
Bellevue, Nebraska, 68123
Research Site
Boerne, Texas, 78006
Research Site
Boston, Massachusetts, 02115
Research Site
Chicago, Illinois, 60602
Research Site
Chicago, Illinois, 60644
Research Site
Clearwater, Florida, 33765
Research Site
Columbia, Missouri, 65203
Research Site
Corsicana, Texas, 75110
Research Site
Costa Mesa, California, 92627
Research Site
Dallas, Texas, 75225
Research Site
El Paso, Texas, 79903
Research Site
Encinitas, California, 92024
Research Site
Erie, Pennsylvania, 16508
Research Site
Farmington Hills, Michigan, 48336
Research Site
Flint, Michigan, 48507
Research Site
Gaffney, South Carolina, 29341
Research Site
Gainesville, Florida, 32653
Research Site
Greenacres City, Florida, 33467
Research Site
Greenfield, Wisconsin, 53228
Research Site
Huntington Beach, California, 92647
Research Site
Knoxville, Tennessee, 37909
Research Site
Lancaster, California, 93534
Research Site
Las Vegas, Nevada, 89106
Research Site
Las Vegas, Nevada, 89119
Research Site
Los Angeles, California, 90017
Research Site
Los Angeles, California, 90048
Research Site
Medford, Oregon, 97504
Research Site
Meridian, Idaho, 83646
Research Site
Miami, Florida, 33126
Research Site
Miami, Florida, 33173
Research Site
Miami, Florida, 33174
Research Site
Miami, Florida, 33186
Research Site
Missoula, Montana, 59808
Research Site
Mobile, Alabama, 36608
Research Site
Monroe, North Carolina, 28112
Research Site
Morgantown, West Virginia, 26505
Research Site
New Hyde Park, New York, 11040
Research Site
New York, New York, 10036
Research Site
Newport Beach, California, 92663
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North Dartmouth, Massachusetts, 02747
Research Site
Oklahoma City, Oklahoma, 73106
Research Site
Oklahoma City, Oklahoma, 73112
Research Site
Orlando, Florida, 32819
Research Site
Oviedo, Florida, 32765
Research Site
Palmetto Bay, Florida, 33157
Research Site
Pembroke Pines, Florida, 33024
Research Site
Pembroke Pines, Florida, 33026
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Portland, Oregon, 97202
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Raleigh, North Carolina, 27607
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Rochester Hills, Michigan, 48307
Research Site
Rolla, Missouri, 65401
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Roseville, California, 95661
Research Site
Sacramento, California, 95823
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San Antonio, Texas, 78207
Research Site
San Antonio, Texas, 78229
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San Diego, California, 92123
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San Jose, California, 95117
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Sherman, Texas, 75092
Research Site
Skillman, New Jersey, 08558
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Spartanburg, South Carolina, 29303
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St Louis, Missouri, 63141
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The Bronx, New York, 10461
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Toms River, New Jersey, 08755
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Tulsa, Oklahoma, 74136
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Warrensburg, Missouri, 64093
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Warwick, Rhode Island, 02886
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Waterbury, Connecticut, 06708
Research Site
White Marsh, Maryland, 21162
Research Site
Woodbury, Minnesota, 55125

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Germany21 sites

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Berlin, 10119
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Berlin, 10787
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About this study

Official title: A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older With Asthma

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.

Conditions: Asthma
Being tested: Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose), Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose), Budesonide metered dose inhaler / BD MDI 160 µg, Albuterol sulfate metered dose inhaler / AS MDI 180 μg, Placebo metered-dose inhaler / Placebo MDI
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)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)
Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose)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)
Budesonide metered dose inhaler / BD MDI 160 µgDrug
Budesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)
Albuterol sulfate metered dose inhaler / AS MDI 180 μgDrug
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 metered-dose inhaler / Placebo MDIOther
Placebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)

Study groups in NCT03847896
Study group	Role	What they receive
BDA MDI (PT027) 160/180 μg	Experimental	Budesonide/Albuterol sulfate BDA MDI (PT027) high dose Receives: Combination Product: Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)
BDA MDI (PT027) 80/180 μg	Experimental	Budesonide/Albuterol sulfate BDA MDI (PT027) low dose Receives: Combination Product: Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose)
BD MDI (PT008) 160 µg	Active comparator	Budesonide BD MDI (PT008) Receives: Drug: Budesonide metered dose inhaler / BD MDI 160 µg
AS MDI (PT007) 180 µg	Active comparator	Albuterol sulfate AS MDI (PT007) Receives: Drug: Albuterol sulfate metered dose inhaler / AS MDI 180 μg
Placebo MDI	Placebo comparator	Placebo MDI Receives: Other: Placebo metered-dose inhaler / Placebo MDI

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Concentration Curve From 0 to 6 Hours (AUC0-6 Hours) Over 12 Weeks
Lung function will be measured by spirometry. Baseline FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures on or before randomization. Starting with the first study drug dose at Week 0 and then at Week 12, spirometry assessments will be completed at 60 and 30 minutes before the morning dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes after dosing. FEV1 AUC0-6 hours will be calculated for changes from baseline (randomization visit) using the trapezoidal rule and will be normalized by dividing by the time (in hours) from dosing to the last measurement included (typically 6 hours).
Measured: Baseline and 12 weeks
Change From Baseline in Trough FEV1
Trough FEV1 is calculated at each clinic visit as the average of the 30- and 60-minute pre-dose FEV1 measurements. Baseline FEV1 is defined as the average of the 30- and 60-minute pre-dose measures collected on the day of randomization.
Measured: Baseline and 12 weeks

Secondary outcomes (4)

Time to 15% Increase in FEV1 Over the Pre-treatment Value on Day 1
The time to onset is defined as the time (minutes) from the first inhalation of randomized treatment (Day 1) to the first instance where a percentage change from baseline in FEV1 of at least 15% is observed. Participants were only to be included in the analysis if a percent change from baseline of at least 15% is observed within a nominal 30 minutes post dose assessment time point. Baseline FEV1 is defined as the average of the 30- and 60- minute pre-dose spirometry measures taken at randomization.
Measured: From first dose (first inhalation of randomized treatment) up to about 40 minutes post-dose (Day 1).
Duration of 15% Increase in FEV1 Over the Pre-treatment Value on Day 1
The duration of onset is defined as the time (minutes) of the continual period in which a percentage increase change from baseline in FEV1 of at least 15% is observed. Participants will only be included in the analyses if a percent change from baseline of at least 15% is observed within a nominal 30 minutes post dose assessment. If a participant has multiple periods of onset, only the first will contribute to the summary. Duration of onset can last up to the last assessment during a nominal 6 hour serial spirometry profile. Baseline FEV1 is defined as the average of the 60- and 30- minute pre-dose spirometry taken at randomization.
Measured: Onset up to about 40 minutes post-treatment, with duration lasting up to the last assessment of a nominal 6 hour serial spirometry profile (Day 1).
Number of Participants With a Clinically Meaningful Difference on the Asthma Control Questionnaire 7-item Version (ACQ-7) at Week 12.
A responder is defined as a participant who achieves a reduction from baseline in overall ACQ-7 score of at least 0.5. The ACQ-7 has 7 questions, with each question using a 7 point scale, where 0 = totally controlled and 6 = extremely poorly controlled. The overall ACQ-7 score is defined as the averaged score across the 7 questions. The analysis only includes participants who are uncontrolled at basellne, i.e. baseline ACQ-7 >= 1.5. All participants who discontinue treatment prior to Week 12 are classified as non-responders.
Measured: Baseline and 12 weeks
Change From Baseline in Trough FEV1 at Week 1.
Trough FEV1 is calculated at each clinic visit as the average of the 60- and 30-minute pre-dose FEV1 measurements. Baseline FEV1 is defined as the average of the 60- and 30-minute pre-dose measures collected on the day of randomization.
Measured: Baseline and 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 201920 Jul 2021

First posted20 Feb 2019
Study start20 Mar 2019
Primary completion20 Jul 2021
Study completion20 Jul 2021

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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,001 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03847896
Sponsor's protocol ID: AV004
Other IDs: 2018-003674-27, 2018
Acronym: DENALI
Status last verified: Apr 2023
First submitted: 14 Feb 2019
Last updated: 13 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37003355

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older With Asthma
ClinicalTrials.gov ID: NCT03847896
Acronym / sponsor ID: DENALI / AV004
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,001 participants (actual)
Lead sponsor: Bond Avillion 2 Development LPIndustry (pharma, biotech, devices)
Study start: 20 Mar 2019 (actual)
Primary completion: 20 Jul 2021 (actual)
Study completion: 20 Jul 2021 (actual)
First posted: 20 Feb 2019 (actual)
Results: Posted 30 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
BDA MDI (PT027) 160/180 μg	Experimental	Combination Product: Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 160/180 μg (high dose)Budesonide/Albuterol sulfate BDA MDI (PT027) high dose
BDA MDI (PT027) 80/180 μg	Experimental	Combination Product: Budesonide/albuterol sulfate metered dose inhaler / BDA MDI 80/180 μg (low dose)Budesonide/Albuterol sulfate BDA MDI (PT027) low dose
BD MDI (PT008) 160 µg	Active comparator	Drug: Budesonide metered dose inhaler / BD MDI 160 µgBudesonide BD MDI (PT008)
AS MDI (PT007) 180 µg	Active comparator	Drug: Albuterol sulfate metered dose inhaler / AS MDI 180 μgAlbuterol sulfate AS MDI (PT007)
Placebo MDI	Placebo comparator	Other: Placebo metered-dose inhaler / Placebo MDIPlacebo MDI

Who may qualify

Ages: 4 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (19 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)
Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
Chronic (≥3 weeks) use of SCS within 6 months prior to Visit 1
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
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)

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
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)	Combination product	BDA MDI (PT027) 160/180 μg
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)	Combination product	BDA MDI (PT027) 80/180 μg
Budesonide metered dose inhaler / BD MDI 160 µgBudesonide pressurized metered dose inhaler (BD MDI) 160 micrograms (μg), given as 2 inhalations of BD MDI 80 μg, four times a day (QID)	Drug	BD MDI (PT008) 160 µg
Albuterol sulfate metered dose inhaler / AS MDI 180 μgAlbuterol sulfate pressurized metered dose inhaler (AS MDI) 180 micrograms (μg), given as 2 inhalations of AS MDI 90 μg, four times a day (QID)	Drug	AS MDI (PT007) 180 µg
Placebo metered-dose inhaler / Placebo MDIPlacebo pressurized metered dose inhaler (Placebo MDI), given as 2 inhalations of Placebo MDI, four times a day (QID)	Other	Placebo MDI

Primary outcome

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Concentration Curve From 0 to 6 Hours (AUC0-6 Hours) Over 12 Weeks
Time frame: Baseline and 12 weeks
Lung function will be measured by spirometry. Baseline FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures on or before randomization. Starting with the first study drug dose at Week 0 and then at Week 12, spirometry assessments will be completed at 60 and 30 minutes before the morning dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes after dosing. FEV1 AUC0-6 hours will be calculated for changes from baseline (randomization visit) using the trapezoidal rule and will be normalized by dividing by the time (in hours) from dosing to the last measurement included (typically 6 hours).
Change From Baseline in Trough FEV1
Time frame: Baseline and 12 weeks
Trough FEV1 is calculated at each clinic visit as the average of the 30- and 60-minute pre-dose FEV1 measurements. Baseline FEV1 is defined as the average of the 30- and 60-minute pre-dose measures collected on the day of randomization.

4 secondary outcomes

Time to 15% Increase in FEV1 Over the Pre-treatment Value on Day 1
Time frame: From first dose (first inhalation of randomized treatment) up to about 40 minutes post-dose (Day 1).
Duration of 15% Increase in FEV1 Over the Pre-treatment Value on Day 1
Time frame: Onset up to about 40 minutes post-treatment, with duration lasting up to the last assessment of a nominal 6 hour serial spirometry profile (Day 1).
Number of Participants With a Clinically Meaningful Difference on the Asthma Control Questionnaire 7-item Version (ACQ-7) at Week 12.
Time frame: Baseline and 12 weeks
Change From Baseline in Trough FEV1 at Week 1.
Time frame: Baseline and 1 week

Results and safety

Results posted to the registry on 30 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BDA MDI (PT027) 160/180 μg	197	190
BDA MDI (PT027) 80/180 μg	204	188
BD MDI (PT008) 160 µg	200	188
AS MDI (PT007) 180 µg	201	184
Placebo MDI	199	178

Primary outcome: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Concentration Curve From 0 to 6 Hours (AUC0-6 Hours) Over 12 Weeks

Time frame: Baseline and 12 weeks. Least squares mean (Standard Error). Unit: milliliters

Measure	BDA MDI (PT027) 160/180 μg n = 197	BDA MDI (PT027) 80/180 μg n = 200	BD MDI (PT008) 160 µg n = 199	AS MDI (PT007) 180 µg n = 195	Placebo MDI n = 196
Value	258.6 (18.87)	242.2 (18.80)	178.0 (18.79)	157.2 (19.08)	96.7 (19.02)

AS MDI (PT007) 180 µg vs Placebo MDI: Mean Difference (Final Values): 60.5 (95% CI 7.7 to 113.4), p = 0.025, ANCOVA
BDA MDI (PT027) 160/180 μg vs Placebo MDI: Mean Difference (Final Values): 161.9 (95% CI 109.4 to 214.5), p <0.001, ANCOVA
BDA MDI (PT027) 160/180 μg vs BD MDI (PT008) 160 µg: Mean Difference (Final Values): 80.7 (95% CI 28.4 to 132.9), p = 0.003, ANCOVA

Primary outcome: Change From Baseline in Trough FEV1

Time frame: Baseline and 12 weeks. Least squares mean (Standard Error). Unit: milliliters

Measure	BDA MDI (PT027) 160/180 μg n = 197	BDA MDI (PT027) 80/180 μg n = 198	BD MDI (PT008) 160 µg n = 198	AS MDI (PT007) 180 µg n = 192	Placebo MDI n = 192
Value	135.5 (24.58)	123.5 (24.65)	108.9 (24.51)	2.7 (25.24)	35.6 (25.12)

BD MDI (PT008) 160 µg vs Placebo MDI: Mean Difference (Final Values): 73.3 (95% CI 4.4 to 142.2), p = 0.037, ANCOVA
BDA MDI (PT027) 160/180 μg vs Placebo MDI: Mean Difference (Final Values): 99.9 (95% CI 30.9 to 168.8), p = 0.005, ANCOVA
BDA MDI (PT027) 160/180 μg vs AS MDI (PT007) 180 µg: Mean Difference (Final Values): 132.8 (95% CI 63.6 to 201.9), p <0.001, ANCOVA

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 12 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BDA MDI (PT027) 160/180 μg	2 of 197 (1%)	37 of 197 (18.8%)	0 of 197
BDA MDI (PT027) 80/180 μg	4 of 204 (2%)	31 of 204 (15.2%)	0 of 204
BD MDI (PT008) 160 µg	3 of 199 (1.5%)	31 of 199 (15.6%)	0 of 199
AS MDI (PT007) 180 µg	1 of 201 (0.5%)	29 of 201 (14.4%)	0 of 201
Placebo MDI	3 of 199 (1.5%)	38 of 199 (19.1%)	0 of 199

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37003355Chipps 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.
Individual participant dataSharing planned: No

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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.

Frank Albers, MD, PhD study director

Avillion LLP

129 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 19 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Germany, Ukraine, Argentina, Czechia and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 30 Sep 2022). 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 Forced Expiratory Volume in 1 Second (FEV1) Area Under the Concentration Curve From 0 to 6 Hours (AUC0-6 Hours) Over 12 Weeks (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03847896, 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 13 Apr 2023.