Chronic Obstructive Pulmonary DiseasePhase 1NCT03311373

A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

A Phase 1 study testing Regimen A, Regimen B and Regimen C in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Regimen A, Regimen B and Regimen C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteUnited States
Study dates: 17 Oct 2017to 15 Dec 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening procedures are performed
Male and female subjects 18 to 40 years of age, inclusive
Be in good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation
Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal, or surgically sterile
Male subjects who are sexually active must agree to use a double-barrier method of contraception (condom with spermicide) from the first dose of randomized study drug until 2 weeks after their last dose, and must not donate sperm during their study participation period
Screening laboratory tests must be within normal range or determined to not be clinically significant by the Investigator.
Demonstrate correct MDI administration technique

Who cannot join

For female subjects, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 4 Treatment Periods
Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
Subjects who have cancer that has not been in complete remission for at least 5 years
Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening
Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
History of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) within 1 year of screening

Show all 12Show fewer

History of smoking or the use of nicotine-containing products within 3 months of screening by self-reporting
A positive alcohol breathalyzer or urine drug screen for drugs of abuse at screening or at the beginning of each Treatment Period
Treatment with any prescription or non-prescription drugs including vitamins, herbal, and dietary supplements for 28 days or 5 half-lives, whichever is longer, before study drug use
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening Period
Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of drug administration or who have been vaccinated with an attenuated live virus within 4 weeks of drug administration
Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (eg, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)

Trial locations and contacts

1 site in 1 country.

United States1 site

Pearl Investigative Site
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal

Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

Read the detailed description

A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Regimen A, Regimen B, Regimen C, Regimen D
Keywords: COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Regimen ADrug
2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure
Regimen BDrug
2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure
Regimen CDrug
2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure
Regimen DDrug
2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure

Study groups in NCT03311373
Study group	Role	What they receive
Treatment Period 1	Experimental	Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C) Receives: Drug: Regimen A; Drug: Regimen B; Drug: Regimen C; Drug: Regimen D
Treatment Period 2	Experimental	Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C) Receives: Drug: Regimen A; Drug: Regimen B; Drug: Regimen C; Drug: Regimen D
Treatment Period 3	Experimental	Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C) Receives: Drug: Regimen A; Drug: Regimen B; Drug: Regimen C; Drug: Regimen D
Treatment Period 4	Experimental	Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C) Receives: Drug: Regimen A; Drug: Regimen B; Drug: Regimen C; Drug: Regimen D

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax)-Budesonide
Maximum plasma concentration (Cmax) per Regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax)-Glycopyrronium
Maximum plasma concentration (Cmax) per Regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum Plasma Concentration (Cmax)-Formoterol
Maximum plasma concentration (Cmax) per Regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide
Each treatment period is equal to assigned regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium
Each treatment period is equal to assigned regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol
Each treatment period is equal to assigned regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

Secondary outcomes (6)

Time to Maximum Plasma Concentration (Tmax)-Budesonide
Each treatment period is equal to assigned regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium
Each treatment period is equal to assigned regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax)-Formoterol
Each treatment period is equal to assigned regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide
Each treatment period is equal to assigned regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium
Each treatment period is equal to assigned regimen
Measured: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol
Each treatment period is equal to assigned regimen
Measured: 24 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 201715 Dec 2017

First posted17 Oct 2017
Study start17 Oct 2017
Primary completion15 Dec 2017
Study completion15 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03311373
Sponsor's protocol ID: PT010011
Status last verified: Jun 2020
First submitted: 11 Oct 2017
Last updated: 11 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Publications

Dorinsky P, DePetrillo P, DeAngelis K, Trivedi R, Darken P, Gillen M. Relative Bioavailability of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Administered With and Without a Spacer: Results of a Phase I, Randomized, Crossover Trial in Healthy Adults. Clin Ther. 2020 Apr;42(4):634-648. doi: 10.1016/j.clinthera.2020.02.012. Epub 2020 Apr 3.
PubMed 32253054

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal
ClinicalTrials.gov ID: NCT03311373
Acronym / sponsor ID: PT010011
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 17 Oct 2017 (actual)
Primary completion: 15 Dec 2017 (actual)
Study completion: 15 Dec 2017 (actual)
First posted: 17 Oct 2017 (actual)
Results: Posted 11 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment Period 1	Experimental	Drug: Regimen A, Drug: Regimen B, Drug: Regimen C, Drug: Regimen DTest Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
Treatment Period 2	Experimental	Drug: Regimen A, Drug: Regimen B, Drug: Regimen C, Drug: Regimen DTest Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Treatment Period 3	Experimental	Drug: Regimen A, Drug: Regimen B, Drug: Regimen C, Drug: Regimen DTest Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Treatment Period 4	Experimental	Drug: Regimen A, Drug: Regimen B, Drug: Regimen C, Drug: Regimen DTest Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening procedures are performed
Male and female subjects 18 to 40 years of age, inclusive
Be in good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation
Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal, or surgically sterile
Male subjects who are sexually active must agree to use a double-barrier method of contraception (condom with spermicide) from the first dose of randomized study drug until 2 weeks after their last dose, and must not donate sperm during their study participation period

Key exclusion criteria (12 listed)

For female subjects, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 4 Treatment Periods
Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
Subjects who have cancer that has not been in complete remission for at least 5 years
Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening
Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Regimen A2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure	Drug	Treatment Period 1, Treatment Period 2, Treatment Period 3, Treatment Period 4
Regimen B2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure	Drug	Treatment Period 1, Treatment Period 2, Treatment Period 3, Treatment Period 4
Regimen C2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure	Drug	Treatment Period 1, Treatment Period 2, Treatment Period 3, Treatment Period 4
Regimen D2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure	Drug	Treatment Period 1, Treatment Period 2, Treatment Period 3, Treatment Period 4

Primary outcome

Maximum Plasma Concentration (Cmax)-Budesonide
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) per Regimen
Maximum Plasma Concentration (Cmax)-Glycopyrronium
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) per Regimen
Maximum Plasma Concentration (Cmax)-Formoterol
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) per Regimen
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Each treatment period is equal to assigned regimen
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Each treatment period is equal to assigned regimen
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Each treatment period is equal to assigned regimen

6 secondary outcomes

Time to Maximum Plasma Concentration (Tmax)-Budesonide
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Time to Maximum Plasma Concentration (Tmax)-Formoterol
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium
Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol
Time frame: 24 hrs

Results and safety

Results posted to the registry on 11 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Regimens	56	47

Primary outcome: Maximum Plasma Concentration (Cmax)-Budesonide

Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Regimen B n = 52	Regimen A n = 52	Regimen C n = 52	Regimen D n = 52
Value	702.3 (46.4)	452.6 (74.6)	340.0 (117.1)	612.0 (74.0)

Population analysed: PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data.

Primary outcome: Maximum Plasma Concentration (Cmax)-Glycopyrronium

Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Regimen B n = 52	Regimen A n = 52	Regimen C n = 51	Regimen D n = 51
Value	47.7 (73.3)	19.0 (131.0)	17.1 (181.7)	42.1 (65.4)

Primary outcome: Maximum Plasma Concentration (Cmax)-Formoterol

Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Regimen B n = 52	Regimen A n = 52	Regimen C n = 51	Regimen D n = 51
Value	18.1 (58.4)	10.8 (66.3)	8.3 (98.6)	17.9 (48.1)

Primary outcome: Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide

Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: h*pg/mL

Measure	Regimen B n = 52	Regimen A n = 52	Regimen C n = 52	Regimen D n = 52
Value	1934.0 (54.9)	1452.8 (66.0)	823.9 (121.2)	1618.5 (74.9)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of administration of the first dose of study drug to the time of the follow-up telephone call, study termination, or study exit up to a total of approximately 12 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Regimen B	0 of 53 (0%)	4 of 53 (7.5%)	0 of 53
Regimen A	0 of 52 (0%)	1 of 52 (1.9%)	0 of 52
Regimen C	0 of 52 (0%)	4 of 52 (7.7%)	0 of 52
Regimen D	0 of 52 (0%)	4 of 52 (7.7%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32253054Dorinsky P, DePetrillo P, DeAngelis K, Trivedi R, Darken P, Gillen M. Relative Bioavailability of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Administered With and Without a Spacer: Results of a Phase I, Randomized, Crossover Trial in Healthy Adults. Clin Ther. 2020 Apr;42(4):634-648. doi: 10.1016/j.clinthera.2020.02.012. Epub 2020 Apr 3.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul M. Dorinsky, MD study director

Pearl Therapeutics, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Regimen A, Regimen B and Regimen C in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax)-Budesonide (time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03311373, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.