Trial Outcomes & Findings for COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2 (NCT NCT04858451)

Last Updated: 2025-01-31

Results Overview

Defined as percentage of participants able to tolerate the test dose, i.e. able to complete the test dose without any of the following: * Troublesome cough, chest pain or tightness, bronchospasm or dyspnoea that is deemed unacceptable by the patient * methaemoglobin \>5% during or \>3% post dose (60 mins) * any treatment-related AE that led to participant not being able to complete the test dose * \>20% reduction in FEV1 pre dose to post dose at 60min if additionally reporting troublesome cough, chest pain or tightness, bronchospasm or dyspnoea that is deemed unacceptable by the patient

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

88 participants

Primary outcome timeframe

Screening Visit

Results posted on

2025-01-31

Participant Flow

total 13 participants enrolled in Part 1A and 10 participants were enrolled in more than one cohort

Participant milestones

Participant milestones
Measure	Part 0 Based on Protocol Version 3.0	Part 1A - SAD 1ml Participants were administered single dose of 1ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1A - SAD 2ml Participants were administered single dose of 2ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1A - SAD 3ml Participants were administered single dose of 3ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1A - SAD 4ml Participants were administered single dose of 4ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1A - SAD 5ml Participants were administered single dose of 5ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1A - SAD 6ml Participants were administered single dose of 6ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1B - MTD 6ml Participants were administered short-acting inhaled bronchodilator (2 inhalations of Ventolin - 100mcg per inhalation) through a spacer device 10 minutes before receiving RESP301 and a single dose of 6ml RESP301 (MTD determined in Part 1a) in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 2 - RTD 4ml Participants were administered a single test dose of RESP301 at the RTD of 4 mL. if tolerated and symptoms of exacerbation developed, eligible participants were to self-administer RESP301 TID for 7 days at the RTD.
Part 0 (Protocol Version 3.0) STARTED	4	0	0	0	0	0	0	0	0
Part 0 (Protocol Version 3.0) COMPLETED	0	0	0	0	0	0	0	0	0
Part 0 (Protocol Version 3.0) NOT COMPLETED	4	0	0	0	0	0	0	0	0
Part 1A - 1ml STARTED	0	8	0	0	0	0	0	0	0
Part 1A - 1ml COMPLETED	0	8	0	0	0	0	0	0	0
Part 1A - 1ml NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 1A - 2ml STARTED	0	0	8	0	0	0	0	0	0
Part 1A - 2ml COMPLETED	0	0	8	0	0	0	0	0	0
Part 1A - 2ml NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 1A - 3ml STARTED	0	0	0	8	0	0	0	0	0
Part 1A - 3ml COMPLETED	0	0	0	8	0	0	0	0	0
Part 1A - 3ml NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 1A - 4ml STARTED	0	0	0	0	8	0	0	0	0
Part 1A - 4ml COMPLETED	0	0	0	0	8	0	0	0	0
Part 1A - 4ml NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 1A - 5ml STARTED	0	0	0	0	0	8	0	0	0
Part 1A - 5ml COMPLETED	0	0	0	0	0	8	0	0	0
Part 1A - 5ml NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 1A - 6ml STARTED	0	0	0	0	0	0	6	0	0
Part 1A - 6ml COMPLETED	0	0	0	0	0	0	6	0	0
Part 1A - 6ml NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 1B STARTED	0	0	0	0	0	0	0	8	0
Part 1B COMPLETED	0	0	0	0	0	0	0	8	0
Part 1B NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 2 STARTED	0	0	0	0	0	0	0	0	63
Part 2 COMPLETED	0	0	0	0	0	0	0	0	0
Part 2 NOT COMPLETED	0	0	0	0	0	0	0	0	63

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 0 Based on Protocol Version 3.0	Part 1A - SAD 1ml Participants were administered single dose of 1ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1A - SAD 2ml Participants were administered single dose of 2ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1A - SAD 3ml Participants were administered single dose of 3ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1A - SAD 4ml Participants were administered single dose of 4ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1A - SAD 5ml Participants were administered single dose of 5ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1A - SAD 6ml Participants were administered single dose of 6ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1B - MTD 6ml Participants were administered short-acting inhaled bronchodilator (2 inhalations of Ventolin - 100mcg per inhalation) through a spacer device 10 minutes before receiving RESP301 and a single dose of 6ml RESP301 (MTD determined in Part 1a) in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 2 - RTD 4ml Participants were administered a single test dose of RESP301 at the RTD of 4 mL. if tolerated and symptoms of exacerbation developed, eligible participants were to self-administer RESP301 TID for 7 days at the RTD.
Part 0 (Protocol Version 3.0) Discontinued	4	0	0	0	0	0	0	0	0
Part 2 Discontinued	0	0	0	0	0	0	0	0	63

Baseline Characteristics

COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 0 n=4 Participants Patients who were enrolled under protocol version 3.0	Part 1A n=13 Participants Participants were administered single ascending dose of RESP301 from 1ml to 6ml in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 1B n=8 Participants Participants were administered short-acting inhaled bronchodilator (2 inhalations of Ventolin - 100mcg per inhalation) through a spacer device 10 minutes before receiving RESP301 and a single dose of 6ml RESP301 (MTD) in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	Part 2 n=16 Participants Participants were administered a single test dose of RESP301 at the RTD of 4 mL. if tolerated and symptoms of exacerbation developed, eligible participants were to self-administer RESP301 TID for 7 days at the RTD.	Total n=41 Participants Total of all reporting groups
Age, Continuous	67.5 years STANDARD_DEVIATION 5.07 • n=5 Participants	68.2 years STANDARD_DEVIATION 6.11 • n=7 Participants	67.6 years STANDARD_DEVIATION 4.78 • n=5 Participants	65.3 years STANDARD_DEVIATION 9.13 • n=4 Participants	66.9 years STANDARD_DEVIATION 7.08 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants	23 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	16 Participants n=4 Participants	41 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Smoking status Current smoker	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Smoking status Former smoker	2 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	11 Participants n=4 Participants	29 Participants n=21 Participants
Smoking status Never smoked	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Height	1.663 m STANDARD_DEVIATION 0.0608 • n=5 Participants	1.648 m STANDARD_DEVIATION 0.1049 • n=7 Participants	1.664 m STANDARD_DEVIATION 0.1119 • n=5 Participants	1.664 m STANDARD_DEVIATION 0.1007 • n=4 Participants	1.659 m STANDARD_DEVIATION 0.0981 • n=21 Participants
Weight	89.53 kg STANDARD_DEVIATION 20.128 • n=5 Participants	75.90 kg STANDARD_DEVIATION 10.992 • n=7 Participants	85.19 kg STANDARD_DEVIATION 14.750 • n=5 Participants	83.31 kg STANDARD_DEVIATION 19.178 • n=4 Participants	81.93 kg STANDARD_DEVIATION 16.207 • n=21 Participants
Body Mass Index	32.650 kg/m² STANDARD_DEVIATION 8.6157 • n=5 Participants	27.954 kg/m² STANDARD_DEVIATION 3.5671 • n=7 Participants	30.600 kg/m² STANDARD_DEVIATION 2.8894 • n=5 Participants	30.144 kg/m² STANDARD_DEVIATION 7.3258 • n=4 Participants	29.783 kg/m² STANDARD_DEVIATION 5.7503 • n=21 Participants

PRIMARY outcome

Timeframe: Screening Visit

Population: participants who received at least one dose of RESP301

Outcome measures

Outcome measures
Measure	SAD-1ml n=8 Participants Participants were administered single dose of 1ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 2ml n=8 Participants Participants were administered single dose of 2ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 3ml n=8 Participants Participants were administered single dose of 3ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 4ml n=8 Participants Participants were administered single dose of 4ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 5ml n=8 Participants Participants were administered single dose of 5ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 6ml n=6 Participants Participants were administered single dose of 6ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	MTD 6ml +SABA MTD 6ml +SABA MTD 6ml +SABA n=8 Participants Participants were administered short-acting inhaled bronchodilator (2 inhalations of Ventolin - 100mcg per inhalation) through a spacer device 10 minutes before receiving RESP301 and a single dose of 6ml RESP301 (MTD) in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	RTD - 4ml Participants were administered a single test dose of RESP301 at the RTD of 4 mL. if tolerated and symptoms of exacerbation developed, eligible participants were to self-administer RESP301 TID for 7 days at the RTD.
Proportion of Patients Tolerating RESP301 at Each Dose Level in Part 1	8 Participants	8 Participants	8 Participants	8 Participants	8 Participants	6 Participants	8 Participants	—

PRIMARY outcome

Timeframe: 1 day

Population: Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no feasibility of self administering RESP301 data was collected.

Defined as percentage of patients who, having experienced and correctly reported an exacerbation, commence self-administration of the treatment on the day the treatment is delivered

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 7 days

Population: Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no feasibility of self administering RESP301 data was collected.

For those participants commencing self-administration of RESP301, the percentage of total doses taken

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening Visit

Population: participants who received at least one dose of RESP301.

Defined as percentage of participants able to tolerate the test dose, i.e. able to complete the test dose without any of the following: * Troublesome cough, chest pain or tightness, bronchospasm or dyspnoea that is deemed unacceptable by the patient * methaemoglobin \>5% during or \>3% post dose (60 mins) * any treatment-related AE that led to participant not being able to complete the test dose, and/or be suitable to be enrolled into the dormant phase in the Investigator's opinion * for the first 50 patients who will undergo pre spirometry, \>20% reduction in FEV1 from pre test dose to post test dose with symptoms (patients with \>20% reduction in FEV1 without symptoms would be offered the option to continue in the study)

Outcome measures

Outcome measures
Measure	SAD-1ml n=8 Participants Participants were administered single dose of 1ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 2ml n=8 Participants Participants were administered single dose of 2ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 3ml n=8 Participants Participants were administered single dose of 3ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 4ml n=8 Participants Participants were administered single dose of 4ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 5ml n=8 Participants Participants were administered single dose of 5ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 6ml n=6 Participants Participants were administered single dose of 6ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	MTD 6ml +SABA MTD 6ml +SABA MTD 6ml +SABA n=8 Participants Participants were administered short-acting inhaled bronchodilator (2 inhalations of Ventolin - 100mcg per inhalation) through a spacer device 10 minutes before receiving RESP301 and a single dose of 6ml RESP301 (MTD) in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	RTD - 4ml n=16 Participants Participants were administered a single test dose of RESP301 at the RTD of 4 mL. if tolerated and symptoms of exacerbation developed, eligible participants were to self-administer RESP301 TID for 7 days at the RTD.
Tolerability of RESP301 (in Part 1a, Part 1b, and Part 2)	8 Participants	8 Participants	8 Participants	8 Participants	8 Participants	4 Participants	7 Participants	12 Participants

SECONDARY outcome

Timeframe: Parts 1A/1B: Screening/dosing period 1-2 days + Follow-up period 1 day. Part 2: Screening period 1-2days (Participants did not enter the treatment phase due to early study termination)

Population: all participants who consented to the study

Defined as total counts and cumulative incidence of Treatment Emergent Adverse Events (TEAEs)

Outcome measures

Outcome measures
Measure	SAD-1ml n=8 Participants Participants were administered single dose of 1ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 2ml n=8 Participants Participants were administered single dose of 2ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 3ml n=8 Participants Participants were administered single dose of 3ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 4ml n=8 Participants Participants were administered single dose of 4ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 5ml n=8 Participants Participants were administered single dose of 5ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 6ml n=6 Participants Participants were administered single dose of 6ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	MTD 6ml +SABA MTD 6ml +SABA MTD 6ml +SABA n=8 Participants Participants were administered short-acting inhaled bronchodilator (2 inhalations of Ventolin - 100mcg per inhalation) through a spacer device 10 minutes before receiving RESP301 and a single dose of 6ml RESP301 (MTD) in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	RTD - 4ml n=63 Participants Participants were administered a single test dose of RESP301 at the RTD of 4 mL. if tolerated and symptoms of exacerbation developed, eligible participants were to self-administer RESP301 TID for 7 days at the RTD.
Safety of RESP301 in Terms of Treatment Emergent Adverse Events	4 # Events	7 # Events	3 # Events	8 # Events	10 # Events	13 # Events	13 # Events	16 # Events

SECONDARY outcome

Timeframe: Parts 1A/1B: Screening/dosing period 1-2 days + Follow-up period 1 day. Part 2: Screening period 1-2days (Participants did not enter the treatment phase due to early study termination)

Population: all participants who consented to the study

Defined as total counts and cumulative incidence of Serious Adverse Events (SAEs)

Outcome measures

Outcome measures
Measure	SAD-1ml n=8 Participants Participants were administered single dose of 1ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 2ml n=8 Participants Participants were administered single dose of 2ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 3ml n=8 Participants Participants were administered single dose of 3ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 4ml n=8 Participants Participants were administered single dose of 4ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 5ml n=8 Participants Participants were administered single dose of 5ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 6ml n=6 Participants Participants were administered single dose of 6ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	MTD 6ml +SABA MTD 6ml +SABA MTD 6ml +SABA n=8 Participants Participants were administered short-acting inhaled bronchodilator (2 inhalations of Ventolin - 100mcg per inhalation) through a spacer device 10 minutes before receiving RESP301 and a single dose of 6ml RESP301 (MTD) in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	RTD - 4ml n=63 Participants Participants were administered a single test dose of RESP301 at the RTD of 4 mL. if tolerated and symptoms of exacerbation developed, eligible participants were to self-administer RESP301 TID for 7 days at the RTD.
Safety of RESP301 in Terms of Serious Adverse Events	0 # Events	0 # Events	0 # Events	0 # Events	0 # Events	0 # Events	0 # Events	6 # Events

SECONDARY outcome

Timeframe: Parts 1A/1B: Screening/dosing period 1-2 days + Follow-up period 1 day. Part 2: Screening period 1-2days (Participants did not enter the treatment phase due to early study termination)

Population: participants who received at least one dose of RESP301.

Defined as total counts and cumulative incidence of Suspected Unexpected Serious Adverse Reactions (SUSARs)

Outcome measures

Outcome measures
Measure	SAD-1ml n=8 Participants Participants were administered single dose of 1ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 2ml n=8 Participants Participants were administered single dose of 2ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 3ml n=8 Participants Participants were administered single dose of 3ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 4ml n=8 Participants Participants were administered single dose of 4ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 5ml n=8 Participants Participants were administered single dose of 5ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 6ml n=6 Participants Participants were administered single dose of 6ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	MTD 6ml +SABA MTD 6ml +SABA MTD 6ml +SABA n=8 Participants Participants were administered short-acting inhaled bronchodilator (2 inhalations of Ventolin - 100mcg per inhalation) through a spacer device 10 minutes before receiving RESP301 and a single dose of 6ml RESP301 (MTD) in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	RTD - 4ml n=16 Participants Participants were administered a single test dose of RESP301 at the RTD of 4 mL. if tolerated and symptoms of exacerbation developed, eligible participants were to self-administer RESP301 TID for 7 days at the RTD.
Safety of RESP301 in Terms of Suspected Unexpected Serious Adverse Reactions	0 # Events	0 # Events	0 # Events	0 # Events	0 # Events	0 # Events	0 # Events	1 # Events

SECONDARY outcome

Timeframe: Parts 1A/1B: Screening/dosing period 1-2 days + Follow-up period 1 day. Part 2: Screening period 1-2days (Participants did not enter the treatment phase due to early study termination)

Population: participants who received at least one dose of RESP301.

Defined as total counts and cumulative incidence of treatment-related AEs

Outcome measures

Outcome measures
Measure	SAD-1ml n=8 Participants Participants were administered single dose of 1ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 2ml n=8 Participants Participants were administered single dose of 2ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 3ml n=8 Participants Participants were administered single dose of 3ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 4ml n=8 Participants Participants were administered single dose of 4ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 5ml n=8 Participants Participants were administered single dose of 5ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	SAD - 6ml n=6 Participants Participants were administered single dose of 6ml RESP301 in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	MTD 6ml +SABA MTD 6ml +SABA MTD 6ml +SABA n=8 Participants Participants were administered short-acting inhaled bronchodilator (2 inhalations of Ventolin - 100mcg per inhalation) through a spacer device 10 minutes before receiving RESP301 and a single dose of 6ml RESP301 (MTD) in the clinic on Day 1, with a follow up safety phone call being conducted on the morning of Day 2 to check for any adverse events.	RTD - 4ml n=16 Participants Participants were administered a single test dose of RESP301 at the RTD of 4 mL. if tolerated and symptoms of exacerbation developed, eligible participants were to self-administer RESP301 TID for 7 days at the RTD.
Safety of RESP301 in Terms of Treatment-related AEs	4 # Events	4 # Events	2 # Events	7 # Events	8 # Events	12 # Events	12 # Events	16 # Events

SECONDARY outcome

Timeframe: 7 days

Population: Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no efficacy data was collected.

Defined as percentage of participants recovered by Day 7 post starting treatment, where recovery is defined as patient feels all their symptoms are back to their usual baseline (all symptom Visual Analogue Scores are 0 on a scale from 0 to 10, where 0 is "same as usual" and 10 is "much more than usual")

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Population: Due to early termination of the study, data were not collected and efficacy could not be analysed

Defined as percentage of participants recovered by Day 14 post starting treatment, where recovery is defined as patient feels all their symptoms are back to their usual baseline (all symptom Visual Analogue Scores are 0 on a scale from 0 to 10, where 0 is "same as usual" and 10 is "much more than usual")

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21 days

Population: Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no efficacy data was collected.

Defined as days to recovery, where recovery is defined as patient feels all their symptoms are back to their usual baseline (all symptom Visual Analogue Scores are 0 on a scale from 0 to 10, where 0 is "same as usual" and 10 is "much more than Defined as percentage of participants recovered by Day 14 post starting treatment, where recovery is defined as patient feels all their symptoms are back to their usual baseline (all symptom Visual Analogue Scores are 0 on a scale from 0 to 10, where 0 is "same as usual" and 10 is "much more than usual")

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Population: Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no efficacy data was collected.

Number of patients treated with RESP301 that experience exacerbation-related hospitalisation and/or death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days

Population: Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no efficacy data was collected.

Change in Clinical COPD Questionnaire (CCQ) score from Day 1 to Day 7, where the minimum score is 0 (very good health status) and maximum score is 6 (extremely poor health status)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 days

Population: Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no feasibility of self administering RESP301 data was collected.

Defined as percentage of patients who, having experienced and correctly reported an exacerbation, receive the treatment within 48 hours of reporting their exacerbation