New combo inhaler shows promise for Hard-to-Control asthma

NCT ID NCT05755906

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a combination inhaler containing both an anti-inflammatory steroid (budesonide) and a fast-acting bronchodilator (formoterol) works better than the steroid alone for people whose asthma is not well controlled. 374 adults and adolescents took part over 12 weeks. The main goal was to measure improvements in lung function shortly after using the inhaler.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

374 people

The number who actually took part.

Started

Feb 2023

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. 12 to 80 years of age, male and female, BMI \<40 kg/m2; females of childbearing potential should be using highly effective birth control. 2. Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines \[GINA 2021\]. Healthcare records for one year prior to Visit 1 must be provided for adolescent participants (12 to \< 18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants. 3. Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with allowed ICS doses, for at least 8 weeks prior to Visit 1. 4. ACQ-7 total score ≥ 1.5 at Visits 1 and 4. 5. A pre-bronchodilator/pre-dose FEV1 \< 90% predicted normal value at Visits 1, 2, and 3 and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization). 6. Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age OR a post-albuterol increase in FEV1 of ≥ 12% for participants 12 to \< 18 years of age either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3, if repeat testing is necessary. 7. A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that has not changed 20% or more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the previous visit. 8. Asthma stability during run-in based on Investigator discretion using the symptom worsening assessment defined in Section 8.1.2.8 as a guideline. 9. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol. 10. Demonstrate acceptable MDI administration technique. 11. eDiary compliance ≥ 70% during screening, defined as completing the daily eDiary and answering "Yes" to taking 2 puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization. Exclusion criteria 1. Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s). 2. Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period. 3. Hospitalization for asthma within 8 weeks of Visit 1. 4. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis. 5. Known history of drug or alcohol abuse within 12 months of Visit 1. 6. Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1. Note: Squamous cell and basal cell carcinomas of the skin are not exclusionary. 7. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in this protocol is prohibited for use during study duration. 8. Previous or current randomization into studies within the AEROSPHERE program including KALOS, LOGOS, VATHOS, LITHOS, or any glycopyrronium studies (PT001). 9. Use of a nebulizer or a home nebulizer for receiving asthma medications. Note: Acute use of a nebulizer for an asthma exacerbation during hospitalization is allowed as long as there is no occurrence within 8 weeks of Visit 1. 10. Do not meet the stable dosing period prior to Visit 1 or unable to abstain from protocol-defined prohibited medications during Screening and Treatment Periods. 11. Receipt of COVID-19 vaccine (regardless of vaccine delivery platform, eg, vector, lipid nanoparticle) ≤7 days prior to Visit 1 (from last vaccination or booster dose). 12. Participants with known hypersensitivity to beta2-agonists, corticosteroids, or any component of the MDI. 13. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG, which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study. 14. Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana). 15. Planned hospitalization during the study. 16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members. 18. Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions and requirements. 19. For women only - currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

Research Site

Chandler, Arizona, 85224, United States
Research Site

Mesa, Arizona, 85213, United States
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Tucson, Arizona, 85745, United States
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Bakersfield, California, 93301, United States
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Encinitas, California, 92024, United States
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Fresno, California, 93720, United States
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Huntington Beach, California, 92647, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90025, United States
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Los Angeles, California, 90048, United States
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Newport Beach, California, 92663, United States
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Northridge, California, 91324, United States
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Sacramento, California, 95823, United States
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San Diego, California, 92123, United States
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San Jose, California, 95117, United States
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Ventura, California, 93003, United States
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Walnut Creek, California, 94598, United States
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Cutler Bay, Florida, 33189, United States
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DeBary, Florida, 32713, United States
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DeLand, Florida, 32720, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33173, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33180, United States
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Plantation, Florida, 33324, United States
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Tampa, Florida, 33607, United States
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Atlanta, Georgia, 30361, United States
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South Bend, Indiana, 46617, United States
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Lexington, Kentucky, 40509, United States
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Annapolis, Maryland, 21401, United States
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White Marsh, Maryland, 21162, United States
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North Dartmouth, Massachusetts, 02747, United States
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Farmington Hills, Michigan, 48336, United States
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Rolla, Missouri, 65401, United States
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St Louis, Missouri, 63141, United States
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Kalispell, Montana, 59901, United States
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Missoula, Montana, 59808, United States
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Bellevue, Nebraska, 68123, United States
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Henderson, Nevada, 89052, United States
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Las Vegas, Nevada, 89102, United States
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North Las Vegas, Nevada, 89030, United States
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Portsmouth, New Hampshire, 03801, United States
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New Windsor, New York, 12553, United States
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Schenectady, New York, 12308, United States
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Fayetteville, North Carolina, 28314, United States
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Raleigh, North Carolina, 27607, United States
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Columbus, Ohio, 43215, United States
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Edmond, Oklahoma, 73034, United States
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Oklahoma City, Oklahoma, 73120, United States
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Hatboro, Pennsylvania, 19040, United States
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Pittsburgh, Pennsylvania, 15236, United States
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Austin, Texas, 78704, United States
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Beaumont, Texas, 77701, United States
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Boerne, Texas, 78006, United States
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El Paso, Texas, 79912, United States
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Forney, Texas, 75126, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Victoria, Texas, 77901, United States
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Waco, Texas, 76712, United States
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American Fork, Utah, 84003, United States
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Bountiful, Utah, 84010, United States
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Milwaukee, Wisconsin, 53228, United States
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Kamloops, British Columbia, V2C 5T1, Canada
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Kelowna, British Columbia, V1Y 4N7, Canada
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Penticton, British Columbia, V2A 5L5, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Toronto, Ontario, M9V 4B4, Canada
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Winchester, Ontario, K0C 2K0, Canada
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Windsor, Ontario, N8X 2G1, Canada
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Montreal, Quebec, H3M 1L3, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G1V 4W2, Canada
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Jindřichův Hradec, 377 01, Czechia
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Louny, 44 001, Czechia
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Lovosice, 410 02, Czechia
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Miroslav, 671 72, Czechia
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Prague, 148 00, Czechia
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Prague, 190 00, Czechia
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Teplice, 415 01, Czechia
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Varnsdorf, 407 47, Czechia
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Alor Star, 5460, Malaysia
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George Town, 10450, Malaysia
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Ipoh, 30990, Malaysia
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Kajang, 43000, Malaysia
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Kota Bharu, 15586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuala Terengganu, 20400, Malaysia
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Sarawak Miri, 98000, Malaysia
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Seremban, 70300, Malaysia
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Iloilo City, 5000, Philippines
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Manila, 1000, Philippines
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Manila, 1014, Philippines
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Marilao, 3019, Philippines
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Durban, 4001, South Africa
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Durban, 4450, South Africa
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Newton, 2113, South Africa
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Pretoria, 0186, South Africa
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Tygervalley, 7530, South Africa
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Daegu, 42415, South Korea
Research Site

Guri-si, 11923, South Korea
Research Site

Jeonju, 54907, South Korea
Research Site

Seoul, 03312, South Korea
Research Site

Ulsan, 44033, South Korea

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