NCT03934333 is a Phase 1 clinical trial of BDA MDI 160/180 mcg in Relative Bioavailability, sponsored by AstraZeneca.

Who is sponsoring NCT03934333?

NCT03934333 is sponsored by AstraZeneca.

What drugs are being tested in NCT03934333?

Interventions in NCT03934333: BDA MDI 160/180 mcg, Pulmicort Flexhaler 180 mcg.

What condition does NCT03934333 study?

NCT03934333 studies Relative Bioavailability.

Is NCT03934333 still recruiting?

NCT03934333 is currently completed. Last updated 1 October 2019.

Last reviewed 2019-10-01 · How we verify

NCT03934333

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 1 October 2019

What this trial tests

Phase 1 trial testing BDA MDI 160/180 mcg in Relative Bioavailability in 11 participants. Completed in 10 September 2019.

Timeline

16 May 2019

Primary endpoint
10 September 2019

10 September 2019

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	16 May 2019
Primary completion	10 September 2019
Estimated completion	10 September 2019
Sites	1 location across United States

Drugs / interventions tested

BDA MDI 160/180 mcg — full drug profile →
Pulmicort Flexhaler 180 mcg — full drug profile →

Conditions studied

Relative Bioavailability — all drugs for Relative Bioavailability →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 55, any sex, with Relative Bioavailability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other AstraZeneca trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03934333 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 1 October 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03934333.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing