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Study stopping criteria were met. A safety event has occurred which was classified as an SAE and was related to the study intervention.
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Patients with a respiratory disease are at higher risk of poor outcomes due to worsening of symptoms caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and other respiratory infections. New therapies are needed for treating high risk patients at early stages of an infection. This study will assess the safety, tolerability and feasibility of using an inhaled nitric oxide generating solution, RESP301, as a self-administered treatment following flare-up of symptoms.
RESP301 is a liquid solution which produces nitric oxide in the lungs when inhaled using a nebuliser. The components of RESP301 are already used in clinical practice and inhaled nitric oxide is used as a treatment for newborns and patients with Chronic Obstructive Pulmonary Disease (COPD). In a laboratory setting, RESP301 has been shown to be effective against respiratory viruses, including SARS-CoV-2.
This study will first determine the maximum tolerated dose of RESP301 in up to 48 adult patients with COPD or bronchiectasis in the United Kingdom (UK) (Part 1a; Dose Finding Phase). Once the Maximum Tolerated Dose (MTD) has been determined in Part 1a, a cohort of 8 patients will be recruited and RESP301 administered at the MTD but these patients will in addition receive a single dose of a short acting bronchodilator 10 minutes preceding administration of RESP301.
After completion of Part 1, approximately 150 patients will be recruited into Part 2 of the trial (Expansion Phase). A minimum of 50 participants will receive a test dose of RESP301 during a screening visit. Response to the test dose will be monitored. Participants who tolerate the test dose will continue in the study and should contact the study team if they experience exacerbation symptoms in the next 52 weeks. Following a call with the site team to discuss symptoms, participants will receive RESP301 delivered to their home to self-administer for 7 days. The study duration for each participant will be at most 57 weeks, including the study visit and monthly calls. Participants who start the course of study treatment, will receive daily calls during the treatment period and will also be followed up after they complete the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | In Part 1a, up to 48 patients will be administered single ascending doses of RESP301 (1-6ml; 8 patients per dose cohort). Provided that individual stopping criteria are not met in ≥3 participants, and there are no serious adverse events that are at least possibly related to RESP301, the next dose cohort can be enrolled. Patients can be enrolled into more than one dose cohort provided they did not meet individual stopping criteria. In Part 1b, 8 participants will receive RESP301 at MTD determined in Part 1a, with short-acting bronchodilator administered 10min prior to RESP301. In Part 2, a minimum of 150 patients will be enrolled. This may include patients who took part in Part 1. At least the first 50 patients will receive a test dose of RESP301 before enrolment into the "dormant phase". Patients who experience flare-up symptoms while in the dormant phase, may proceed to the treatment phase where they will self-administer RESP301 at home for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESP301 | Drug | A single RESP301 dose administered at a study site to assess tolerability. In patients who experience a flare-up during the study period, self-administered RESP301 treatment for 7 days, 3 times a day. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Tolerating RESP301 at Each Dose Level in Part 1 | Defined as percentage of participants able to tolerate the test dose, i.e. able to complete the test dose without any of the following:
| Screening Visit |
| Feasibility of Self-administering RESP301 Treatment in Terms of Commencing Treatment | 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 | 1 day |
| Feasibility of Self-administering RESP301 Treatment in Terms of Treatment Compliance | For those participants commencing self-administration of RESP301, the percentage of total doses taken | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of RESP301 (in Part 1a, Part 1b, and Part 2) | Defined as percentage of participants able to tolerate the test dose, i.e. able to complete the test dose without any of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicines Evaluation Unit | Manchester | United Kingdom | ||||
| The Newcastle upon Tyne Hospitals NHS Foundation Trust |
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total 13 participants enrolled in Part 1A and 10 participants were enrolled in more than one cohort
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 0 | Based on Protocol Version 3.0 |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 0 (Protocol Version 3.0) |
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| Part 1A - 1ml |
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| Part 1A - 2ml |
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| Part 1A - 3ml |
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| Part 1A - 4ml |
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| Part 1A - 5ml |
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| Part 1A - 6ml |
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| Part 1B |
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| Part 2 |
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participants who received at least one dose of RESP301.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 0 | Patients who were enrolled under protocol version 3.0 |
| BG001 | Part 1A | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Tolerating RESP301 at Each Dose Level in Part 1 | Defined as percentage of participants able to tolerate the test dose, i.e. able to complete the test dose without any of the following:
| participants who received at least one dose of RESP301 | Posted | Count of Participants | Participants | Screening Visit |
|
Part 0: Screening/baseline visit Day 0. 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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 0 | Based on Protocol Version 3.0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (26.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Inva Hoti, PhD | Thirty Respiratory Ltd | +44 (0) 1235 431200 | Inva.Hoti@30.technology |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2021 | Nov 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 3, 2024 | May 10, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Part 1a: Dose Finding Phase
Up to 48 eligible participants will be administered single ascending doses of RESP301 to determine the maximum tolerated dose, according to the following schedule:
Part 1b: Concomitant Medication Expansion Phase
• 8 participants to receive RESP301 at MTD with short-acting bronchodilator administered 10min prior to RESP301
Part 2: Expansion Phase
A minimum of 150 patients will be enrolled in to the Expansion Phase. These may include eligible participants from Part 1.
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| Screening Visit |
| Safety of RESP301 in Terms of Treatment Emergent Adverse Events | Defined as total counts and cumulative incidence of Treatment Emergent Adverse Events (TEAEs) | 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) |
| Safety of RESP301 in Terms of Serious Adverse Events | Defined as total counts and cumulative incidence of Serious Adverse Events (SAEs) | 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) |
| Safety of RESP301 in Terms of Suspected Unexpected Serious Adverse Reactions | Defined as total counts and cumulative incidence of Suspected Unexpected Serious Adverse Reactions (SUSARs) | 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) |
| Safety of RESP301 in Terms of Treatment-related AEs | Defined as total counts and cumulative incidence of treatment-related AEs | 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) |
| Efficacy of RESP301 in Terms of Percentage of Patients Recovered by Day 7 | 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") | 7 days |
| Efficacy of RESP301 in Terms of Percentage of Patients Recovered by Day 14 | 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") | 7 days |
| Efficacy of RESP301 in Terms of Time to Recovery | 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") | 21 days |
| Efficacy of RESP301 in Terms of Preventing Exacerbation-related Hospitalisation and/or Death | Number of patients treated with RESP301 that experience exacerbation-related hospitalisation and/or death | 7 days |
| Efficacy of RESP301 in Terms of Patient-reported Symptoms | 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) | 7 days |
| Feasibility of Self-administering RESP301 Treatment in Terms of Receiving Treatment | Defined as percentage of patients who, having experienced and correctly reported an exacerbation, receive the treatment within 48 hours of reporting their exacerbation | 2 days |
| Newcastle upon Tyne |
| United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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|
| BG002 | Part 1B | 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. |
| BG003 | Part 2 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | m |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m² |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | MTD 6ml +SABA MTD 6ml +SABA MTD 6ml +SABA | 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. |
|
|
| Primary | Feasibility of Self-administering RESP301 Treatment in Terms of Commencing Treatment | 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 | 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. | Posted | 1 day |
|
|
| Primary | Feasibility of Self-administering RESP301 Treatment in Terms of Treatment Compliance | For those participants commencing self-administration of RESP301, the percentage of total doses taken | 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. | Posted | 7 days |
|
|
| Secondary | Tolerability of RESP301 (in Part 1a, Part 1b, and Part 2) | Defined as percentage of participants able to tolerate the test dose, i.e. able to complete the test dose without any of the following:
| participants who received at least one dose of RESP301. | Posted | Count of Participants | Participants | Screening Visit |
|
|
|
| Secondary | Safety of RESP301 in Terms of Treatment Emergent Adverse Events | Defined as total counts and cumulative incidence of Treatment Emergent Adverse Events (TEAEs) | all participants who consented to the study | Posted | Number | # Events | 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) |
|
|
|
| Secondary | Safety of RESP301 in Terms of Serious Adverse Events | Defined as total counts and cumulative incidence of Serious Adverse Events (SAEs) | all participants who consented to the study | Posted | Number | # Events | 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) |
|
|
|
| Secondary | Safety of RESP301 in Terms of Suspected Unexpected Serious Adverse Reactions | Defined as total counts and cumulative incidence of Suspected Unexpected Serious Adverse Reactions (SUSARs) | participants who received at least one dose of RESP301. | Posted | Number | # Events | 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) |
|
|
|
| Secondary | Safety of RESP301 in Terms of Treatment-related AEs | Defined as total counts and cumulative incidence of treatment-related AEs | participants who received at least one dose of RESP301. | Posted | Number | # Events | 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) |
|
|
|
| Secondary | Efficacy of RESP301 in Terms of Percentage of Patients Recovered by Day 7 | 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") | Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no efficacy data was collected. | Posted | 7 days |
|
|
| Secondary | Efficacy of RESP301 in Terms of Percentage of Patients Recovered by Day 14 | 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") | Due to early termination of the study, data were not collected and efficacy could not be analysed | Posted | 7 days |
|
|
| Secondary | Efficacy of RESP301 in Terms of Time to Recovery | 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") | Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no efficacy data was collected. | Posted | 21 days |
|
|
| Secondary | Efficacy of RESP301 in Terms of Preventing Exacerbation-related Hospitalisation and/or Death | Number of patients treated with RESP301 that experience exacerbation-related hospitalisation and/or death | Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no efficacy data was collected. | Posted | 7 days |
|
|
| Secondary | Efficacy of RESP301 in Terms of Patient-reported Symptoms | 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) | Due to early termination of the study, no participants entered the Treatment Period of Part 2, and therefore no efficacy data was collected. | Posted | 7 days |
|
|
| Secondary | Feasibility of Self-administering RESP301 Treatment in Terms of Receiving Treatment | Defined as percentage of patients who, having experienced and correctly reported an exacerbation, receive the treatment within 48 hours of reporting their exacerbation | 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. | Posted | 2 days |
|
|
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Part 1A - 1ml | In Part 1a, up to 48 patients will be administered single ascending doses of RESP301 (1-6ml; 8 patients per dose cohort). Provided that individual stopping criteria are not met in ≥3 participants, and there are no serious adverse events that are at least possibly related to RESP301, the next dose cohort can be enrolled. Patients can be enrolled into more than one dose cohort provided they did not meet individual stopping criteria. In Part 1b, 8 participants will receive RESP301 at MTD determined in Part 1a, with short-acting bronchodilator administered 10min prior to RESP301. In Part 2, a minimum of 150 patients will be enrolled. This may include patients who took part in Part 1. At least the first 50 patients will receive a test dose of RESP301 before enrolment into the "dormant phase". Patients who experience flare-up symptoms while in the dormant phase, may proceed to the treatment phase where they will self-administer RESP301 at home for 7 days. RESP301: A single RESP301 dose administered at a study site to assess tolerability. In patients who experience a flare-up during the study period, self-administered RESP301 treatment for 7 days, 3 times a day. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG002 | Part 1A - 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. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG003 | Part 1A - 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. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG004 | Part 1A - 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. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG005 | Part 1A - 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. | 0 | 8 | 0 | 8 | 5 | 8 |
| EG006 | Part 1A - 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 | 0 | 6 | 0 | 6 | 4 | 6 |
| EG007 | Part 1B - 6ml +SABA | 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. | 0 | 8 | 1 | 8 | 6 | 8 |
| EG008 | Part 2 - RTD 4ml RTD 4ml 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. | 0 | 16 | 4 | 16 | 5 | 16 |
| Decompensated heart failure | Cardiac disorders | MedDRA (26.1) | Non-systematic Assessment |
|
| End stage COPD | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
|
| Lobar collapse | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
|
| Compressed Fracture | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Non-systematic Assessment |
|
| Severe Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Non-systematic Assessment |
|
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |