ClinicalTrials.gg
Sign In
CompletedNCT03311373Updated Jun 11, 2020Results posted

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

A Phase 1 interventional study of Regimen A and Regimen B in Chronic Obstructive Pulmonary Disease, sponsored by Pearl Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.

Sponsored by Pearl Therapeutics, Inc. (part of AstraZeneca) · Phase 1, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca — 14 open to participants now, 15 under way, 4 of them phase 3. Pulmonary Disease, Chronic Obstructive · AstraZeneca.

Enrollment
135th of 194
56 · median 137
Started
2017
with 13 others
Phase 1
42 of 284
none open now
Registered
211th of 284
by date

Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, this one is the 135th largest by enrollment of the 194 interventional ones that give a count, is one of 14 that started in 2017, is one of 42 in phase 1, and was the 211th registered.

Pulmonary Disease, Chronic Obstructive

5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

14 of the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:

9 more — sign in →

By country, each count listing its studies:

Argentina5
Mexico5
China4
Denmark4
Germany4
India4
Korea, Republic of4
Taiwan4
Turkey4
United Kingdom4
United States4
Vietnam4

All 14 open studies →

Who these studies take

Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.

This study: 18 Years to 40 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved 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, , vital signs, and clinical laboratory evaluation
  • Non- (ie, physiologically incapable of becoming pregnant, including any female who is 2 years , or surgically sterile
  • Male subjects who are sexually active must agree to use a double-barrier method of (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 by the Investigator.
  • Demonstrate correct MDI administration technique

Key Exclusion Criteria:

  • 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
  • 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 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)
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

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

Study arms

  • Experimental
    Treatment Period 1

    Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)

    Drug: Regimen A · Drug: Regimen B · Drug: Regimen C · Drug: Regimen D

  • Experimental
    Treatment Period 2

    Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)

    Drug: Regimen A · Drug: Regimen B · Drug: Regimen C · Drug: Regimen D

  • Experimental
    Treatment Period 3

    Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)

    Drug: Regimen A · Drug: Regimen B · Drug: Regimen C · Drug: Regimen D

  • Experimental
    Treatment Period 4

    Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)

    Drug: Regimen A · Drug: Regimen B · Drug: Regimen C · Drug: Regimen D

Interventions

  • DrugRegimen A

    2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure

  • DrugRegimen B

    2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure

  • DrugRegimen C

    2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure

  • DrugRegimen D

    2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)-Budesonide

    Maximum plasma concentration (Cmax) per Regimen

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

  2. Maximum Plasma Concentration (Cmax)-Glycopyrronium

    Maximum plasma concentration (Cmax) per Regimen

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

  3. Maximum Plasma Concentration (Cmax)-Formoterol

    Maximum plasma concentration (Cmax) per Regimen

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

  4. 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

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

  5. 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

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

  6. 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

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

Secondary outcomes

  1. Time to Maximum Plasma Concentration (Tmax)-Budesonide

    Each treatment period is equal to assigned regimen

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

  2. Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium

    Each treatment period is equal to assigned regimen

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

  3. Time to Maximum Plasma Concentration (Tmax)-Formoterol

    Each treatment period is equal to assigned regimen

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

  4. Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide

    Each treatment period is equal to assigned regimen

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

  5. Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium

    Each treatment period is equal to assigned regimen

    Time frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose

  6. Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol

    Each treatment period is equal to assigned regimen

    Time frame: 24 hrs

07

Results

Posted Jun 11, 2020

Participant flow

This study was conducted at a single center in the United States from November 2017 to December 2017.

Participant flow — Overall Study
MilestoneAll Regimens
Started56
Completed47
Not completed9
Withdrew: Adverse event1
Withdrew: Protocol discontinuation criteria3
Withdrew: Lost to follow-up1
Withdrew: Physician decision1
Withdrew: Withdrawal by subject3

Outcome measures

PrimaryMaximum Plasma Concentration (Cmax)-Budesonide

Maximum plasma concentration (Cmax) per Regimen

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Geometric mean · pg/mL
Maximum Plasma Concentration (Cmax)-Budesonide
pg/mLRegimen BRegimen ARegimen CRegimen D
Maximum Plasma Concentration (Cmax)-Budesonide702.3 ± 46.4452.6 ± 74.6340.0 ± 117.1612.0 ± 74.0
PrimaryMaximum Plasma Concentration (Cmax)-Glycopyrronium

Maximum plasma concentration (Cmax) per Regimen

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Geometric mean · pg/mL
Maximum Plasma Concentration (Cmax)-Glycopyrronium
pg/mLRegimen BRegimen ARegimen CRegimen D
Maximum Plasma Concentration (Cmax)-Glycopyrronium47.7 ± 73.319.0 ± 131.017.1 ± 181.742.1 ± 65.4
PrimaryMaximum Plasma Concentration (Cmax)-Formoterol

Maximum plasma concentration (Cmax) per Regimen

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Geometric mean · pg/mL
Maximum Plasma Concentration (Cmax)-Formoterol
pg/mLRegimen BRegimen ARegimen CRegimen D
Maximum Plasma Concentration (Cmax)-Formoterol18.1 ± 58.410.8 ± 66.38.3 ± 98.617.9 ± 48.1
PrimaryArea 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

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Geometric mean · h*pg/mL
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide
h*pg/mLRegimen BRegimen ARegimen CRegimen D
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide1934.0 ± 54.91452.8 ± 66.0823.9 ± 121.21618.5 ± 74.9
PrimaryArea 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

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Geometric mean · h*pg/mL
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium
h*pg/mLRegimen BRegimen ARegimen CRegimen D
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium74.3 ± 96.448.1 ± 122.419.8 ± 325.069.2 ± 85.2
PrimaryArea 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

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Geometric mean · h*pg/mL
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol
h*pg/mLRegimen BRegimen ARegimen CRegimen D
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol35.9 ± 97.537.0 ± 88.78.9 ± 471.833.1 ± 71.3
SecondaryTime to Maximum Plasma Concentration (Tmax)-Budesonide

Each treatment period is equal to assigned regimen

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Median · h (hour)
Time to Maximum Plasma Concentration (Tmax)-Budesonide
h (hour)Regimen BRegimen ARegimen CRegimen D
Time to Maximum Plasma Concentration (Tmax)-Budesonide0.33 (0.10 to 1.00)0.33 (0.10 to 2.00)0.33 (0.10 to 2.00)0.33 (0.10 to 1.00)
SecondaryTime to Maximum Plasma Concentration (Tmax)-Glycopyrronium

Each treatment period is equal to assigned regimen

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Median · h (hour)
Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium
h (hour)Regimen BRegimen ARegimen CRegimen D
Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium0.03 (0.03 to 0.67)0.03 (0.03 to 4.00)0.03 (0.03 to 0.67)0.03 (0.03 to 0.10)
SecondaryTime to Maximum Plasma Concentration (Tmax)-Formoterol

Each treatment period is equal to assigned regimen

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Median · h (hour)
Time to Maximum Plasma Concentration (Tmax)-Formoterol
h (hour)Regimen BRegimen ARegimen CRegimen D
Time to Maximum Plasma Concentration (Tmax)-Formoterol0.10 (0.03 to 0.67)0.10 (0.03 to 4.00)0.10 (0.03 to 0.67)0.10 (0.03 to 0.33)
SecondaryArea Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide

Each treatment period is equal to assigned regimen

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Geometric mean · h*pg/mL
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide
h*pg/mLRegimen BRegimen ARegimen CRegimen D
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide2132.1 ± 40.91491.8 ± 64.4823.9 ± 121.21806.2 ± 39.1
SecondaryArea Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium

Each treatment period is equal to assigned regimen

Time frame:
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Reported as:
Geometric mean · h*pg/mL
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium
h*pg/mLRegimen BRegimen ARegimen CRegimen D
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium40.4 ± 49.665.9 ± 44.715.2 ± 54.539.2 ± 96.5
SecondaryArea Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol

Each treatment period is equal to assigned regimen

Time frame:
24 hrs
Reported as:
Geometric mean · h*pg/mL
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol
h*pg/mLRegimen BRegimen ARegimen CRegimen D
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol63.2 ± 37.162.7 ± 62.262.6 ± 55.062.0 ± 42.2

Adverse events

Collected over 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.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Regimen B0/53 (0%)0/53 (0%)4/53 (7.5%)
Regimen A0/52 (0%)0/52 (0%)1/52 (1.9%)
Regimen C0/52 (0%)0/52 (0%)4/52 (7.7%)
Regimen D0/52 (0%)0/52 (0%)4/52 (7.7%)
Most frequent other events
Most frequent other events
EventRegimen BRegimen ARegimen CRegimen D
HeadacheNervous system disorders3/531/522/522/52
CoughRespiratory, thoracic and mediastinal disorders0/530/522/522/52
DizzinessNervous system disorders2/530/520/521/52

Baseline characteristics

Age, Continuous
Age, Continuous(Years)All Subjects
Mean29.9 ± 5.3
Sex/Gender, Customized
Sex/Gender, Customized(Participants)All Subjects
Male34
Female22
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Subjects
Hispanic or Latino0
Not Hispanic or Latino56
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Subjects
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American47
White7
More than one race0
Unknown or Not Reported1
08

Study locations

1 site
  • Pearl Investigative Site
    Baltimore, Maryland 21201, United States
09

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Dec 2017, 1 month.

Results were first posted in Jun 2020, 2 years 5 months after primary completion.

Of 158 industry-sponsored phase 1 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's 1 month is below that.

Counting every sponsor, half of 176 studies reached it within 4 months; a quarter within 2 and three quarters within 11.

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

Registered
Oct 11, 2017
First posted
Oct 17, 2017
StartActual
Oct 17, 2017
Primary completionActual
Dec 15, 2017
CompletionActual
Dec 15, 2017
Results first posted
Jun 11, 2020
Last update
Jun 11, 2020
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 Jun 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03311373
Lead sponsor
Pearl Therapeutics, Inc.
Responsible party
Sponsor
First posted
Oct 17, 2017
Start date
Oct 17, 2017
Primary completion
Dec 15, 2017
Completion
Dec 15, 2017
Results posted
Jun 11, 2020
Last update
Jun 11, 2020

Study contacts

Paul M. Dorinsky, MD
study director · Pearl Therapeutics, Inc.

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: XS005

Other studies in this condition

Pulmonary Disease, Chronic Obstructive →

Other studies from this sponsor

Pearl Therapeutics, Inc. →

Start the discussion