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CompletedNCT03934333Updated Oct 1, 2019

A Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 Compared With Pulmicort Flexhaler (ELBRUS)

A Phase 1 interventional study of BDA MDI 160/180 mcg and Pulmicort Flexhaler 180 mcg in Relative Bioavailability, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study is to compare the systemic exposure of budesonide delivered by the combination inhaler (budesonide/albuterol sulfate pressurized inhalation suspension [BDA metered dose inhaler {BDA MDI}]) with Pulmicort Flexhaler dry-powder inhaler (DPI).

Read the detailed description

This study will be an open-label, randomized, 2-way cross-over study in healthy adult male or female participants, performed at a single study center.Participants will receive single doses of BDA MDI or Pulmicort Flexhaler on 2 occasions, under fasted conditions. There will be a minimum washout period of 3 days between each dose administration. A total of 66 participants will be randomized in this study to ensure that at least 62 participants are evaluable. The study will comprise of screening period of maximum 27 days; Two treatment periods during which participants will be resident from the day prior to administration of budesonide/albuterol sulfate pressurized inhalation suspension metered dose inhaler (BDA MDI) or Pulmicort Flexhaler (Day -1) until at least 24 hours after dosing. Participants will be discharged on the morning of Day 2; and a final follow-up visit within 5 to 7 days after the last administration of BDA MDI or Pulmicort Flexhaler.

02

Conditions studied

  • Relative Bioavailability

Keywords

  • Pharmacokinetics
  • Inhaled corticosteroid
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,498 studies on the registry; 269 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Provision of signed and dated, written informed consent prior to any study specific procedures.
  2. Healthy male and female participants aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
  3. Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating.
  4. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
  5. Must be able to demonstrate proper inhalation technique using the Vitalograph Aerosol Inhalation Monitor (AIM) device 3 repeated times as well as be able to use the BDA MDI and Pulmicort Flexhaler devices according to instructions.
  6. Forced expiratory volume in 1 second in liters (FEV1) ≥80% of predicted value and FEV1/forced vital capacity in liters (FVC) ratio ≥70%.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or nursing female participants or participants who are trying to conceive
  2. For female participants, a positive serum human chorionic gonadotropin (hCG) test at the Screening Visit or a positive urine hCG at admission for any of the 2 Treatment Periods.
  3. History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
  4. History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  5. Participants who have cancer that has not been in complete remission for at least 5 years.
  6. Any history of asthma or Chronic obstructive pulmonary disease (COPD).
  7. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
  8. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at the Screening Visit, as judged by the PI.
  9. Any clinically significant abnormal findings in vital signs at the Screening Visit, as judged by the PI.
  10. Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at the Screening Visit, as judged by the PI.
  11. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
  12. Known or suspected history of alcohol or drug abuse, or excessive intake of alcohol, in past 2 years, as judged by the PI.
  13. Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest.
  14. Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to the Screening Visit.
  15. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to budesonide, albuterol sulfate and any component of the MDI and DPI.
  16. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
  17. Positive screen for drugs of abuse, cotinine or alcohol at the Screening Visit or on each admission to the Clinical Unit.
  18. Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
  19. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
  20. Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
  21. Judgment by the PI that the participant should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
  22. Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    A/B (BDA MDI/Pulmicort)

    For each participant, the BDA MDI/Pulmicort Flexhaler DPI will be administered as a single dose (2 inhalations) on Day 1 of the respective treatment period per the assigned treatment sequence. The IMP will be administered in the morning, at approximately the same time of day throughout the study (±30 minutes).

    Drug: BDA MDI 160/180 mcg · Drug: Pulmicort Flexhaler 180 mcg

  • Experimental
    B/A (Pulmicort/ BDA MDI)

    For each participant, the Pulmicort Flexhaler DPI / BDA MDI will be administered as a single dose (2 inhalations) on Day 1 of the respective treatment period per the assigned treatment sequence. The IMP should be administered in the morning, at approximately the same time of day throughout the study (±30 minutes).

    Drug: BDA MDI 160/180 mcg · Drug: Pulmicort Flexhaler 180 mcg

Interventions

  • DrugBDA MDI 160/180 mcg

    Budesonide/albuterol sulfate pressurized inhalation suspension, single dose given as 2 inhalations of 80/90 mcg.

  • DrugPulmicort Flexhaler 180 mcg

    Pulmicort Flexhaler aerosol, power, single-dose given as 2 inhalations of 90 mcg.

06

What researchers measure

Primary outcomes

  1. Area under plasma concentration-time curve from time zero to infinity (AUC) for budesonide

    To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler

    Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)

  2. Area under the plasma concentration-curve from time zero to time of last quantifiable concentration [AUC(0-t)] for budesonide

    To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler

    Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)

  3. Maximum observed plasma concentration (Cmax) for budesonide

    To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler

    Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)

Secondary outcomes

  1. Time to reach maximum observed plasma concentration (tmax)

    To determine tmax for budesonide delivered by BDA MDI and Pulmicort Flexhaler

    Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)

  2. Time of last quantifiable plasma concentration (tlast)

    To determine tlast for budesonide delivered by BDA MDI and Pulmicort Flexhaler

    Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)

  3. Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz)

    To determine t½λz for budesonide delivered by BDA MDI and Pulmicort Flexhaler

    Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)

  4. Terminal elimination rate constant (λz)

    To determine λz for budesonide delivered by BDA MDI and Pulmicort Flexhaler

    Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)

  5. Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

    To determine CL/F for budesonide delivered by BDA MDI and Pulmicort Flexhaler

    Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)

  6. Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

    To determine Vz/F for budesonide delivered by BDA MDI and Pulmicort Flexhaler

    Time frame: On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)

  7. Number of participants with adverse events and serious adverse events

    To assess the safety and tolerability of BDA MDI and Pulmicort Flexhaler

    Time frame: From screening (Day -27 to Day -2) to post study visit ( 5-7 days)

07

Study locations

1 site
  • Research Site
    Baltimore, Maryland 21225, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2019 to primary completion in Sep 2019, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2019
First posted
May 1, 2019
StartActual
May 16, 2019
Primary completionActual
Sep 10, 2019
CompletionActual
Sep 10, 2019
Last update
Oct 1, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03934333
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
May 1, 2019
Start date
May 16, 2019
Primary completion
Sep 10, 2019
Completion
Sep 10, 2019
Last update
Oct 1, 2019

Study contacts

Dr. Ronald Goldwater, MD
principal investigator · MD

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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