Budesonide + Formoterol for Asthma

(COMPAIR Trial)

Recruiting at 5 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must be taking: SABA, ICS, LTRA, LABA

Must not be taking: Budesonide, Formoterol

Disqualifiers: Severe respiratory abnormalities, Life-threatening asthma, others

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

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

Compensation: Varies

Number of Visits: 3

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the pharmacokinetics (PK) and safety of symbicort aerosphere and symbicort pressurized metered dose inhaler (pMDI) in participants with asthma aged 4 to less than 12 years.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am currently using a medium dose of inhaled steroids and a long-acting bronchodilator.

I am a female who has started periods and my pregnancy test is negative.

I meet a main requirement for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment Period 1

Participants receive a single dose of either Symbicort Aerosphere or Symbicort pMDI

1 day

1 visit (in-person)

Washout

A washout period between treatment periods

4-6 weeks

Treatment Period 2

Participants receive a single dose of the alternate treatment (Symbicort Aerosphere or Symbicort pMDI)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

Follow-up telephone call

What Are the Treatments Tested in This Trial?

Interventions

• Budesonide
• Formoterol

How Is the Trial Designed?

Group I: Sequence BA Experimental Treatment 2 Interventions

In study period 1, participants will receive a single dose of treatment B (reference formulation) and in study period 2, participants will receive a single dose of treatment A (test formulation).

Group II: Sequence AB Experimental Treatment 2 Interventions

In study period 1, participants will receive a single dose of treatment A (test formulation) and in study period 2, participants will receive a single dose of treatment B (reference formulation).

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