PT010 Inhaler for Asthma

(KALOS Trial)

Recruiting at 316 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: ICS/LABA

Must not be taking: Biologics, LAMA, Immunosuppressives, others

Disqualifiers: COPD, Smoking, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

2274 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care

Research Team

Andrew Menzies-Gow, MD

Principal Investigator

Royal Brompton Hospital, United Kingdom

Eligibility Criteria

This trial is for adults and adolescents aged 12-80 with severe asthma that isn't well-controlled by their current treatment. They must have a BMI under 40, not be pregnant or breastfeeding, and use effective birth control if applicable. Participants should have been on a stable dose of inhaled corticosteroids and long-acting beta agonists for at least four weeks.

Inclusion Criteria

I am between 12 and 80 years old, my BMI is under 40, and if female, I am not able to have children or am using effective birth control.

I have been on a stable daily asthma medication regimen for at least 4 weeks.

My lung function test after using albuterol shows my FEV1 level.

Exclusion Criteria

I have not taken any corticosteroids in the last 4 weeks.

I have had severe asthma attacks that required breathing support.

I have untreated narrow angle glaucoma or vision changes in the last 3 months.

Treatment Details

Interventions

• Budesonide/Glycopyrronium/Formoterol Inhaler

Trial Overview The study tests different doses of an inhaler containing budesonide/glycopyrronium/formoterol (BFF/BGF) to see how safe and effective they are compared to standard care for severe asthma. The trial will randomly assign participants to receive one of the various dosages.

Participant Groups

Group I: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg Experimental Treatment 1 Intervention

BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)

Group II: BGF MDI 320/14.4/9.6 μg Experimental Treatment 1 Intervention

BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)

Group III: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg Active Control 1 Intervention

BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI)

Group IV: Symbicort® Active Control 1 Intervention

Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology