Trial Outcomes & Findings for Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects (NCT NCT00893971)

NCT ID: NCT00893971

Last Updated: 2017-04-26

Results Overview

Number of participants reporting dry mouth at 12 hours post-dose

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: 12 hours
• Results posted on: 2017-04-26

Participant Flow

Conducted at a single site in Australia from May 2009 through July 2009. Study participation was a maximum of 7 weeks.

Study evaluating a single administration of inhaled treatment (PT001, PT003, PT005 and PT001+PT005 delivered from separate inhalers as a loose combination).Each subject was randomized to 1 of 4 sequences. Each sequence included the four treatment groups.

Participant milestones

Measure	Overall Study All patients randomized
Overall Study STARTED	16
Overall Study Placebo + GP MDI (PT001)	15
Overall Study Placebo + GFF MDI (PT003)	15
Overall Study Placebo + FF MDI (PT005)	13
Overall Study GP MDI (PT001) + FF MDI (PT005)	16
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Overall Study All patients randomized
Overall Study Physician Decision	3

Baseline Characteristics

Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects

Baseline characteristics by cohort

Measure	All Subjects n=16 Participants Any treatment arm
Age, Continuous	27.4 Years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

Population: All subjects in the Safety Population

Number of participants reporting dry mouth at 12 hours post-dose

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Symptoms of Dry Mouth 4-hours post-dose	1 Participants	1 Participants	3 Participants	0 Participants
Symptoms of Dry Mouth Immediately pre-dose	3 Participants	1 Participants	3 Participants	1 Participants
Symptoms of Dry Mouth 30 minutes post-dose	4 Participants	3 Participants	4 Participants	5 Participants
Symptoms of Dry Mouth 1-hour post-dose	3 Participants	2 Participants	3 Participants	3 Participants
Symptoms of Dry Mouth 2-hours post-dose	3 Participants	1 Participants	3 Participants	1 Participants
Symptoms of Dry Mouth 6-hours post-dose	1 Participants	1 Participants	2 Participants	NA Participants If no dry mouth is present up to the 2 hr time point, then no further assessments are required. If dry mouth is present, then assessments are continued until the AE is resolved.
Symptoms of Dry Mouth 8-hours post-dose	1 Participants	1 Participants	2 Participants	NA Participants If no dry mouth is present up to the 2 hr time point, then no further assessments are required. If dry mouth is present, then assessments are continued until the AE is resolved.
Symptoms of Dry Mouth 12-hours post-dose	1 Participants	1 Participants	2 Participants	NA Participants If no dry mouth is present up to the 2 hr time point, then no further assessments are required. If dry mouth is present, then assessments are continued until the AE is resolved.

PRIMARY outcome

Timeframe: 12 hours

Population: All subjects in the Safety Population

Number of participants reporting tremor at 12 hours post-dose

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Symptoms of Tremor 2-hours post-dose	0 Participants	0 Participants	1 Participants	0 Participants
Symptoms of Tremor Immediately pre-dose	0 Participants	0 Participants	0 Participants	0 Participants
Symptoms of Tremor 30-minutes post-dose	0 Participants	0 Participants	0 Participants	0 Participants
Symptoms of Tremor 1-hour post-dose	0 Participants	0 Participants	0 Participants	0 Participants
Symptoms of Tremor 4-hours post-dose	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required	1 Participants	1 Participants	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required
Symptoms of Tremor 6-hours post-dose	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required	0 Participants	0 Participants	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required
Symptoms of Tremor 8-hours post-dose	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required
Symptoms of Tremor 12-hours post-dose	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required	NA Participants If no tremor was present at the previous 2-hour time point, no further assessment was required

PRIMARY outcome

Timeframe: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

Population: All patients in the Safety Population that had a valid measurement for the parameter

Series of 11 blood chemistries assessed throughout the study

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Blood Chemistry Change From Baseline Sodium	0.76 mmol/L Interval -3.0 to 4.0	0.78 mmol/L Interval -1.0 to 3.0	0.35 mmol/L Interval -2.0 to 6.0	0.6 mmol/L Interval -2.0 to 3.0
Blood Chemistry Change From Baseline Chloride	-1.29 mmol/L Interval -7.0 to 2.0	-0.4 mmol/L Interval -4.0 to 4.0	-0.75 mmol/L Interval -5.0 to 6.0	-1.2 mmol/L Interval -3.0 to 0.0
Blood Chemistry Change From Baseline Urea	0.12 mmol/L Interval -0.9 to 1.4	-0.05 mmol/L Interval -1.3 to 1.8	-0.11 mmol/L Interval -2.6 to 1.5	-0.33 mmol/L Interval -3.3 to 1.1
Blood Chemistry Change From Baseline Calcium	-0.01 mmol/L Interval -0.1 to 0.08	-0.04 mmol/L Interval -0.2 to 0.06	-0.03 mmol/L Interval -0.21 to 0.08	-0.01 mmol/L Interval -0.11 to 0.09
Blood Chemistry Change From Baseline Bicarbonate	0.64 mmol/L Interval -2.0 to 4.0	0.05 mmol/L Interval -4.0 to 2.0	0.44 mmol/L Interval -5.0 to 6.0	0.47 mmol/L Interval -5.0 to 3.0
Blood Chemistry Change From Baseline Glucose	-0.17 mmol/L Interval -2.5 to 1.1	-0.34 mmol/L Interval -2.4 to 1.2	-0.34 mmol/L Interval -2.0 to 1.1	0.45 mmol/L Interval -1.9 to 2.5

PRIMARY outcome

Timeframe: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

Population: All subjects in the Safety Population that had a valid measurement for the parameter

Series of 11 blood chemistries assessed throughout the study

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Blood Chemistry Change From Baseline Creatinine	2.19 µmol/L Interval -11.0 to 11.0	1.45 µmol/L Interval -15.0 to 12.0	0.44 µmol/L Interval -14.0 to 11.0	-0.8 µmol/L Interval -13.0 to 11.0
Blood Chemistry Change From Baseline Bilirubin	-1.4 µmol/L Interval -6.0 to 3.0	-2.18 µmol/L Interval -5.0 to 0.0	-2.32 µmol/L Interval -6.0 to 1.0	-2.07 µmol/L Interval -10.0 to 2.0

PRIMARY outcome

Timeframe: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

Population: All patients in the Safety Population that had a valid measurement for the parameter

Series of 11 blood chemistries assessed throughout the study

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Blood Chemistry Change From Baseline ALP	2.99 U/L Interval -3.0 to 10.0	3.59 U/L Interval -3.0 to 12.0	1.39 U/L Interval -9.0 to 9.0	2 U/L Interval -9.0 to 11.0
Blood Chemistry Change From Baseline ALT	0.07 U/L Interval -6.0 to 5.0	-1.21 U/L Interval -8.0 to 4.0	-0.41 U/L Interval -5.0 to 5.0	-0.33 U/L Interval -5.0 to 6.0
Blood Chemistry Change From Baseline AST	-0.83 U/L Interval -10.0 to 7.0	0.25 U/L Interval -5.0 to 6.0	-2.91 U/L Interval -14.0 to 4.0	-1.67 U/L Interval -10.0 to 4.0

PRIMARY outcome

Timeframe: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

Population: All subjects in the Safety Population that had a valid measurement for the parameter

Hematology assessments taken throughout the study Hematocrit

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=15 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Hematology Change From Baseline	0.01 % of Red Blood Cells in the blood Interval -0.07 to 0.03	0.01 % of Red Blood Cells in the blood Interval -0.02 to 0.04	0.01 % of Red Blood Cells in the blood Interval -0.02 to 0.03	0.01 % of Red Blood Cells in the blood Interval -0.02 to 0.04

PRIMARY outcome

Timeframe: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

Population: All subjects in the Safety Population that had a valid measurement for the parameter

Hematology assessments taken throughout the study

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=15 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Hematology Change From Baseline WCC	17.93 (10^9 cells/L) Interval -13.0 to 39.0	20.61 (10^9 cells/L) Interval -1.0 to 55.0	10.8 (10^9 cells/L) Interval -31.0 to 43.0	20.33 (10^9 cells/L) Interval -17.0 to 54.0
Hematology Change From Baseline Platelets	1.08 (10^9 cells/L) Interval -1.0 to 3.0	0.88 (10^9 cells/L) Interval -1.0 to 3.0	0.93 (10^9 cells/L) Interval 0.0 to 3.0	0.67 (10^9 cells/L) Interval -4.0 to 3.0

PRIMARY outcome

Timeframe: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

Population: All subjects in the Safety Population that had a valid measurement for the parameter

Hematology assessments taken throughout the study Hemoglobin

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=15 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Hematology Change From Baseline	2.45 g/L Interval -24.0 to 11.0	2.95 g/L Interval -6.0 to 10.0	1.73 g/L Interval -4.0 to 10.0	3.33 g/L Interval -9.0 to 9.0

PRIMARY outcome

Timeframe: 12 hours

Population: All subjects in the Safety Population that had a valid measurement for the parameter

Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Heart Rate Change From Baseline	2.0 bpm Interval -7.0 to 13.0	4.4 bpm Interval -12.0 to 21.0	2.9 bpm Interval -3.0 to 11.0	1.8 bpm Interval -13.0 to 19.0

PRIMARY outcome

Timeframe: 12 hours

Population: All subjects in the Safety Population that had a valid measurement for the parameter

Vital sign change baseline; blood pressure

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Vital Sign Change Baseline; Blood Pressure Systolic blood pressure (mmHg)	3.3 mmHg Interval -14.0 to 18.0	1.0 mmHg Interval -20.0 to 14.0	0.1 mmHg Interval -9.0 to 14.0	0.4 mmHg Interval -8.0 to 13.0
Vital Sign Change Baseline; Blood Pressure Diastolic blood pressure (mmHg)	6.3 mmHg Interval -8.0 to 24.0	1.5 mmHg Interval -13.0 to 10.0	0.6 mmHg Interval -12.0 to 12.0	1.6 mmHg Interval -14.0 to 28.0

PRIMARY outcome

Timeframe: 12 hours

Population: All subjects in the Safety Population that had a valid measurement for the parameter

Vital Sign Change from baseline 12-hours post-dose SpO2 (%)

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Vital Sign Change From Baseline, SpO2	0.2 % blood oxygen saturation level Interval -2.0 to 2.0	0.1 % blood oxygen saturation level Interval -1.0 to 3.0	-0.1 % blood oxygen saturation level Interval -2.0 to 1.0	0.1 % blood oxygen saturation level Interval -1.0 to 2.0

PRIMARY outcome

Timeframe: 12 hours

Population: Safety population

Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm)

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
ECG Change From Baseline	1.5 bpm Interval -7.0 to 9.0	4.7 bpm Interval -18.0 to 22.0	5.2 bpm Interval -4.0 to 25.0	4.0 bpm Interval -9.0 to 13.0

PRIMARY outcome

Timeframe: 12 hours

Population: Safety population

Change from baseline for ECG parameters 12-hours post-dose

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
ECG Change From Baseline PR interval (ms)	-11.0 ms Interval -126.0 to 10.0	-8.3 ms Interval -20.0 to 2.0	-5.3 ms Interval -24.0 to 24.0	-10.4 ms Interval -34.0 to 14.0
ECG Change From Baseline QRS duration (ms)	-3.0 ms Interval -10.0 to 4.0	-5.4 ms Interval -18.0 to 10.0	0.4 ms Interval -10.0 to 42.0	-2.0 ms Interval -12.0 to 10.0
ECG Change From Baseline QT interval (ms)	-8.6 ms Interval -32.0 to 4.0	-9.4 ms Interval -42.0 to 20.0	-10.1 ms Interval -60.0 to 16.0	-12.8 ms Interval -26.0 to 10.0
ECG Change From Baseline QTcB (ms)	-3.7 ms Interval -24.0 to 18.0	5.3 ms Interval -36.0 to 41.0	5.4 ms Interval -17.0 to 39.0	-2.1 ms Interval -26.0 to 31.0
ECG Change From Baseline QTcF (ms)	-5.1 ms Interval -25.0 to 12.0	0.0 ms Interval -19.0 to 16.0	-0.1 ms Interval -23.0 to 21.0	-5.9 ms Interval -18.0 to 24.0

PRIMARY outcome

Timeframe: 12 hours

Population: Safety population

Change from baseline for spirometery measures 12-hours post-dose

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Spirometry Change From Baseline FEV1 (L)	0.260 Liters Interval -0.28 to 0.49	0.148 Liters Interval -0.53 to 0.43	0.202 Liters Interval -0.27 to 0.71	0.195 Liters Interval -0.33 to 0.49
Spirometry Change From Baseline FVC (L)	0.145 Liters Interval -0.51 to 0.47	0.0 Liters Interval -0.82 to 0.44	0.082 Liters Interval -0.49 to 0.53	0.045 Liters Interval -0.64 to 0.5

PRIMARY outcome

Timeframe: 12 hours

Population: Safety population

Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted)

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Spirometry Change From Baseline	7.2 % predicted Interval -8.0 to 12.0	4.5 % predicted Interval -12.0 to 12.0	5.2 % predicted Interval -8.0 to 15.0	5.0 % predicted Interval -7.0 to 15.0

PRIMARY outcome

Timeframe: 12 hours

Population: Safety population

Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%)

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Spirometry Change From Baseline	3.0 Ratio Interval -4.0 to 10.0	3.4 Ratio Interval 0.0 to 7.0	3.2 Ratio Interval -4.0 to 9.0	3.6 Ratio Interval 1.0 to 8.0

PRIMARY outcome

Timeframe: 12 hours

Population: Safety population

Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)

Outcome measures

Measure	Placebo + PT001 n=15 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Spirometry Change From Baseline	40.4 L/min Interval 0.0 to 93.0	32.1 L/min Interval -120.0 to 150.0	40.1 L/min Interval -63.0 to 135.0	31.6 L/min Interval -99.0 to 102.0

PRIMARY outcome

Timeframe: 12 hours

Population: All subjects in the Safety Population

Outcome measures

Measure	Placebo + PT001 n=14 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=12 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=15 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=14 Participants Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Serum Potassium Change From Baseline	4.4 mmol/L Interval 4.0 to 5.1	4.1 mmol/L Interval 3.5 to 4.9	4.1 mmol/L Interval 3.7 to 4.8	4.2 mmol/L Interval 3.8 to 4.7

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Various pharmacokinetic parameters for plasma glycopyrrolate

Outcome measures

Measure	Placebo + PT001 n=12 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=12 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=12 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Glycopyrrolate PK Parameters AUC0-tlast (h*pg/mL)	156.6 h*pg/mL Standard Deviation 76.7 • Interval -0.28 to 0.49	100.1 h*pg/mL Standard Deviation 43.1 • Interval -0.27 to 0.71	78.4 h*pg/mL Standard Deviation 36.2 • Interval -0.33 to 0.49	—
Plasma Glycopyrrolate PK Parameters AUC0-12 (h*pg/mL)	156.7 h*pg/mL Standard Deviation 76.5 • Interval -8.0 to 12.0	100.6 h*pg/mL Standard Deviation 42.4 • Interval -8.0 to 15.0	80.1 h*pg/mL Standard Deviation 34.9 • Interval -7.0 to 15.0	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Various pharmacokinetic parameters for plasma glycopyrrolate

Outcome measures

Measure	Placebo + PT001 n=9 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=8 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=9 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL)	172.4 h*pg/mL Standard Deviation 88.6	137.2 h*pg/mL Standard Deviation 55.4	100.8 h*pg/mL Standard Deviation 50.5	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Various pharmacokinetic parameters for plasma glycopyrrolate

Outcome measures

Measure	Placebo + PT001 n=12 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=12 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=12 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Glycopyrrolate PK Parameters (Tmax)	0.16 h Standard Deviation 0.14 • Interval -0.51 to 0.47	0.07 h Standard Deviation 0.06 • Interval -0.49 to 0.53	0.06 h Standard Deviation 0.03 • Interval -0.64 to 0.5	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Various pharmacokinetic parameters for plasma glycopyrrolate

Outcome measures

Measure	Placebo + PT001 n=9 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=8 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=9 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Glycopyrrolate PK Parameters (t1/2)	5.34 h Standard Deviation 1.78	5.12 h Standard Deviation 1.61	5.12 h Standard Deviation 2.07	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Various pharmacokinetic parameters for plasma glycopyrrolate

Outcome measures

Measure	Placebo + PT001 n=12 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=12 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=12 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Glycopyrrolate PK Parameters Cmax (pg/mL)	61.3 pg/mL Standard Deviation 40.9 • Interval -4.0 to 10.0	77.8 pg/mL Standard Deviation 72.0 • Interval -4.0 to 9.0	44.4 pg/mL Standard Deviation 18.3 • Interval 1.0 to 8.0	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Various pharmacokinetic parameters for plasma glycopyrrolate

Outcome measures

Measure	Placebo + PT001 n=9 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=8 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=9 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Glycopyrrolate PK Parameters (ke)	0.143 1/h Standard Deviation 0.047	0.147 1/h Standard Deviation 0.042	0.155 1/h Standard Deviation 0.059	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Various pharmacokinetic parameters for plasma formoterol

Outcome measures

Measure	Placebo + PT001 n=11 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=11 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=11 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Formoterol PK Parameters AUC0-tlast (h*pg/mL)	47.9 h*pg/mL Standard Deviation 12.3 • Interval -120.0 to 150.0	61.2 h*pg/mL Standard Deviation 16.5 • Interval -63.0 to 135.0	57.9 h*pg/mL Standard Deviation 16.3 • Interval -99.0 to 102.0	—
Plasma Formoterol PK Parameters AUC0-12 (h*pg/mL)	48.1 h*pg/mL Standard Deviation 12.2	61.2 h*pg/mL Standard Deviation 16.6	57.8 h*pg/mL Standard Deviation 16.2	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Various pharmacokinetic parameters for plasma formoterol

Outcome measures

Measure	Placebo + PT001 n=8 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=7 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=8 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL)	56.1 h*pg/mL Standard Deviation 8.3	76.4 h*pg/mL Standard Deviation 18.5	67.0 h*pg/mL Standard Deviation 12.8	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Various pharmacokinetic parameters for plasma formoterol

Outcome measures

Measure	Placebo + PT001 n=11 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=11 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=11 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Formoterol PK Parameters (Tmax)	0.28 h Standard Deviation 0.31 • Interval -120.0 to 150.0	0.27 h Standard Deviation 0.59 • Interval -63.0 to 135.0	0.43 h Standard Deviation 0.46 • Interval -99.0 to 102.0	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Various pharmacokinetic parameters for plasma formoterol

Outcome measures

Measure	Placebo + PT001 n=8 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=7 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=8 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Formoterol PK Parameters (t1/2)	5.12 h Standard Deviation 1.10	5.28 h Standard Deviation 1.02	5.8 h Standard Deviation 1.32	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Pharmacokinetic parameters for plasma formoterol Cmax

Outcome measures

Measure	Placebo + PT001 n=11 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=11 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=11 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Formoterol PK Parameters (Cmax)	10.4 pg/mL Standard Deviation 3.8 • Interval -120.0 to 150.0	13.2 pg/mL Standard Deviation 4.5 • Interval -63.0 to 135.0	11.9 pg/mL Standard Deviation 4.0 • Interval -99.0 to 102.0	—

SECONDARY outcome

Timeframe: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Population: Subjects with an evaluable profile for this analyte

Pharmacokinetic parameters for plasma formoterol ke

Outcome measures

Measure	Placebo + PT001 n=8 Participants Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=7 Participants Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=8 Participants Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Plasma Formoterol PK Parameters (ke)	0.142 1/h Standard Deviation 0.035 • Interval -120.0 to 150.0	0.135 1/h Standard Deviation 0.025 • Interval -63.0 to 135.0	0.126 1/h Standard Deviation 0.032 • Interval -99.0 to 102.0	—

Adverse Events

Placebo + PT001

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo + PT005

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

PT001 + PT005

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo + PT003

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo + PT001 n=15 participants at risk Placebo + Glycopyrrolate MDI 72 µg	Placebo + PT005 n=13 participants at risk Placebo + Formoterol Fumarate 9.6 µg	PT001 + PT005 n=16 participants at risk Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)	Placebo + PT003 n=15 participants at risk Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
Eye disorders Dry eye	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	7.7% 1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/16 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
Gastrointestinal disorders Dry mouth	13.3% 2/15 • Number of events 2 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	23.1% 3/13 • Number of events 3 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	25.0% 4/16 • Number of events 4 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	26.7% 4/15 • Number of events 4 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
Gastrointestinal disorders Toothache	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/13 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/16 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/15 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
General disorders Chest discomfort	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/13 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/16 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/15 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
Infections and infestations Upper respiratory tract infection	0.00% 0/15 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	7.7% 1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	6.2% 1/16 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
Injury, poisoning and procedural complications Contusion	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/13 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/16 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/15 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
Musculoskeletal and connective tissue disorders Muscle tightness	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/13 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/16 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/15 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
Nervous system disorders Dizziness	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	7.7% 1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	6.2% 1/16 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
Nervous system disorders Headache	13.3% 2/15 • Number of events 3 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	7.7% 1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	6.2% 1/16 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	33.3% 5/15 • Number of events 5 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
Nervous system disorders Tremor	0.00% 0/15 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	7.7% 1/13 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	12.5% 2/16 • Number of events 2 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
Reproductive system and breast disorders Dysmenorrhea	0.00% 0/15 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/13 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	6.2% 1/16 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/15 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
Respiratory, thoracic and mediastinal disorders Rhinitis	13.3% 2/15 • Number of events 3 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/13 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	0.00% 0/16 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.	6.7% 1/15 • Number of events 1 • Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit. Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.

Additional Information

Colin Reisner, MD, FCCP, FAAAAI

Pearl Therapeutics Inc.

Phone: 605-305-2600

Email: creisner@pearltherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
• Publication restrictions are in place

Restriction type: OTHER