COPDPhase 2CORVISNCT04858451
COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2
A Phase 2 study testing RESP301 in people with COPD and Bronchiectasis, run by Thirty Respiratory Limited at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- COPD, Bronchiectasis
- What is being tested?
- RESP301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Mar 2021to 8 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female of non-childbearing potential or male ≥35 years of age, at the time of signing the informed consent
- Able and willing to provide informed consent
- Spirometry-confirmed diagnosis of COPD (FEV1/FVC<0.7 post-bronchodilator) or computerised tomography (CT) proven bronchiectasis
- Part 1 only: FEV1 ≥50% predicted at screen 1 (i.e. FEV1 prior to any in-clinic administered short acting bronchodilator)
Who cannot join
- Unable to safely use a nebuliser as required by the study according to Investigator's opinion
- Severe COPD or bronchiectasis defined as FEV1 <20% or requiring non-invasive ventilation
- History of methaemoglobinaemia
- Baseline methaemoglobin concentration (using fingertip sensor) > 2%
- Uncontrolled or severe asthma or history of severe bronchospasm
- Presence of tracheostomy/inability to provide spirometry or contraindication for performing spirometry
Show all 16Show fewer
- Allergy to any of the components of the study intervention
- Participation in other clinical investigations utilising investigational treatment within the last 30 days / 5 half lives whichever is longer
- Deemed unlikely to be able to adhere to protocol in view of investigator
- Any subject who in the opinion of the investigator would not be best served by participating in this clinical trial
- Any unstable, uncontrolled or severe medical condition which in the opinion of the investigator would make the patient unsuitable for the trial
- Participant lives at home with no other adults in the household (Part 2 only)
- On long-term non-invasive ventilation and/or at higher risk of bronchospasm
- Prescribed Nitric Oxide donating agent (Nitroprusside, Isosorbide dinitrate, Isosorbide mononitrate, Naproxcinod, Molsidomine and Linsidomine)
- Female of childbearing potential
- Clinical diagnosis of COPD but Screening Visit spirometry at study centre excludes COPD (i.e. FEV1/FVC post bronchodilator ratio is not <0.7)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Medicines Evaluation Unit
Manchester
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
About this study
Official title: Community Participants With COPD or Bronchiectasis and at Risk of Respiratory Viral Infections Including SARS-CoV-2: An Open-label, Multicentre Feasibility Study of an Inhaled Nitric Oxide Generating Solution (RESP301)
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.
Read more
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.
- Conditions
- COPD, Bronchiectasis
- Being tested
- RESP301
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESP301Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: RESP301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
Measured: 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
Measured: 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
Measured: 7 days
Secondary outcomes (11)
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:
- 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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")
Measured: 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")
Measured: 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")
Measured: 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
Measured: 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)
Measured: 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
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Mar 2021
- Primary completion22 Dec 2022
- Study completion8 Feb 2023
Why it stopped: Study stopping criteria were met. A safety event has occurred which was classified as an SAE and was related to the study intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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: * 8 participants to receive RESP301 at a dose of 1 ml * 8 participants to receive RESP301 at a dose of 2 ml * 8 participants to receive RESP301 at a dose of 3 ml * 8 participants to receive RESP301 at a dose of 4 ml * 8 participants to receive RESP301 at a dose of 5 ml * 8 participants to receive RESP301 at a dose of 6 ml 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.
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thirty Respiratory Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858451
- Sponsor's protocol ID
- RESP301-005
- Acronym
- CORVIS
- Status last verified
- Jan 2025
- First submitted
- 19 Apr 2021
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Participants With COPD or Bronchiectasis and at Risk of Respiratory Viral Infections Including SARS-CoV-2: An Open-label, Multicentre Feasibility Study of an Inhaled Nitric Oxide Generating Solution (RESP301)
- ClinicalTrials.gov ID
- NCT04858451
- Acronym / sponsor ID
- CORVIS / RESP301-005
- Conditions
- COPD, Bronchiectasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopping criteria were met. A safety event has occurred which was classified as an SAE and was related to the study intervention.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Thirty Respiratory LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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: * 8 participants to receive RESP301 at a dose of 1 ml * 8 participants to receive RESP301 at a dose of 2 ml * 8 participants to receive RESP301 at a dose of 3 ml * 8 participants to receive RESP301 at a dose of 4 ml * 8 participants to receive RESP301 at a dose of 5 ml * 8 participants to receive RESP301 at a dose of 6 ml 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.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Drug: RESP301In 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female of non-childbearing potential or male ≥35 years of age, at the time of signing the informed consent
- Able and willing to provide informed consent
- Spirometry-confirmed diagnosis of COPD (FEV1/FVC<0.7 post-bronchodilator) or computerised tomography (CT) proven bronchiectasis
- Part 1 only: FEV1 ≥50% predicted at screen 1 (i.e. FEV1 prior to any in-clinic administered short acting bronchodilator)
Key exclusion criteria (16 listed)
- Unable to safely use a nebuliser as required by the study according to Investigator's opinion
- Severe COPD or bronchiectasis defined as FEV1 <20% or requiring non-invasive ventilation
- History of methaemoglobinaemia
- Baseline methaemoglobin concentration (using fingertip sensor) > 2%
- Uncontrolled or severe asthma or history of severe bronchospasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESP301A 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. | Drug | All participants |
Primary outcome
Proportion of Patients Tolerating RESP301 at Each Dose Level in Part 1
Time frame: Screening Visit
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
Feasibility of Self-administering RESP301 Treatment in Terms of Commencing Treatment
Time frame: 1 day
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
Feasibility of Self-administering RESP301 Treatment in Terms of Treatment Compliance
Time frame: 7 days
For those participants commencing self-administration of RESP301, the percentage of total doses taken
11 secondary outcomes
Tolerability of RESP301 (in Part 1a, Part 1b, and Part 2)
Time frame: Screening Visit
Safety of RESP301 in Terms of Treatment Emergent Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7 days
Efficacy of RESP301 in Terms of Percentage of Patients Recovered by Day 14
Time frame: 7 days
Efficacy of RESP301 in Terms of Time to Recovery
Time frame: 21 days
Efficacy of RESP301 in Terms of Preventing Exacerbation-related Hospitalisation and/or Death
Time frame: 7 days
Efficacy of RESP301 in Terms of Patient-reported Symptoms
Time frame: 7 days
Feasibility of Self-administering RESP301 Treatment in Terms of Receiving Treatment
Time frame: 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RESP301 in people with COPD and Bronchiectasis, run by Thirty Respiratory Limited at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Tolerating RESP301 at Each Dose Level in Part 1 (time frame: Screening Visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.