Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT04759807
A Phase 1b Study of PUR1800 in Patients With COPD
A Phase 1 study testing PUR1800 250 ug and PUR1800 500 ug in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pulmatrix Inc. at 1 site in United Kingdom.
Trial summary
This is a randomised, placebo-controlled, double-blind 3-way crossover study in which PUR1800, or placebo is dosed daily for 14 consecutive days in adult subjects with stable COPD over three discrete TPs. Subjects will be randomised to one of the following 3 treatment sequences: Sequence Period 1 Period 2 Period 3 1. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- PUR1800 250 ug and PUR1800 500 ug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2021to 2 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all the following:
- Male or female patients aged 40 to 75 years of age with a body mass index
- ≥ 17 and ≤ 35 kg/m2.
- Female patients must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method (See Section 9.4.1).
- Male patients with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success or use highly effective contraception together with their female partner(s) (See Section 9.4.1).
- Female patients must agree not to donate ova/oocytes during the study and for 30 days after the last dose of IMP.
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- Male patients must agree not to donate semen during the study and for 90 days after the last dose of IMP.
- Confirmed diagnosis by a physician of COPD with symptoms compatible with COPD for at least 1 year prior to screening.
- Severity of Disease: patients who conform to the current severity classification for GOLD Grade II/III disease in terms of post-bronchodilator spirometry at screening: Post-salbutamol FEV1/FVC ratio of < 0.70. Post-salbutamol FEV1 ≥ 40 % and ≤ 80 % of predicted normal values (based on the Global Lung Function Initiative [GLI-2012][1]).
- Current or previous tobacco smoker with a smoking history of ≥ 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent).
- Vital signs recorded from automated blood pressure equipment within the following normal ranges: Blood pressure; systolic value of 90 mmHg to 160 mmHg, diastolic value of 60 mmHg to 90 mmHg and pulse rate ≥ 60 and
- ≤100 beats per minute at screening and prior to randomisation.
- Able to provide written Informed Consent Form (ICF) prior to participation in any study-related activities, and to comply with the requirements of the study.
- Able to perform technically acceptable spirometry at screening.
- Able to produce a sputum sample of adequate quality at either the Screening or Baseline visit prior to randomisation.
- Able to demonstrate the correct inhalation technique for use of the delivery device and to generate sufficient peak inspiratory flow (PIF) (at least 40 L/min) using the In-Check DIAL device at screening and prior to randomisation.
Who cannot join
- Patients who meet any of the following are not eligible:
- Upper or lower respiratory tract infection within 6 weeks prior to screening or prior to randomisation.
- COPD exacerbation requiring oral steroids and/or antibiotics, within the 6 weeks prior to screening or prior to randomisation.
- Clinically significant abnormal laboratory values at screening that, in the opinion of the investigator would make the patient inappropriate for the study or put the patient at undue risk, specifically liver function tests (LFTs: aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transferase [GGT], total bilirubin) >3 x upper limit of normal (ULN); hemoglobin <10 gm/dL; absolute neutrophil count (ANC) <1000; white blood cells (WBC) >20,000; Platelets <100,000 and >500,000; prothrombin time (PT) >14 seconds.
- QTcF of >450 msec in males or >470 msec in females on any of the three individual ECG measurements at screening or prior to randomisation.
- History of drug or alcohol abuse within the past 2 years prior to screening or prior to randomisation.
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- History of regular alcohol consumption within 6 months prior to screening or prior to randomisation defined as an average weekly intake of >21 units for males, or >14 units for females, where one unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- Positive alcohol breath test result at screening or prior to randomisation.
- Positive urine drugs of abuse test result (unless in the opinion of the investigator this can be explained by the patient's current medications) at screening or prior to randomisation; unexpected or unexplained positive results may require discussion with Sponsor.
- Current users of e-cigarettes and those who have used these products within one month prior to screening or between screening and randomisation.
- Known sensitivity to the study drug or any of the excipients of the formulation, or history of clinically significant sensitivity to any agent that, in the opinion of the investigator, would make participation in the study inadvisable.
- Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug, or intention to donate blood or blood products during the study.
- Participated in an interventional study involving an experimental therapeutic agent within 3 months of screening or prior to randomisation.
- Women who have a positive serum β-human chorionic gonadotropin (hCG) pregnancy test at screening or a positive urinary hCG pregnancy test prior to randomisation, is pregnant, lactating, or planning to become pregnant during the study.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or HIV results. Patients who are HBs antibody positive or HB core antibody positive are not excluded provided the HBsAg result is negative. Patients who are HCV Ab positive are not excluded if a subsequent HCV RNA test is negative.
- Planned surgery or procedures during the participation of the study and for 28 days after the conclusion of study participation.
- Employee of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of that investigator or study centre, as well as family members of the employees or the investigator.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- The patient is unable or unwilling to comply fully with the study protocol.
- Patient is mentally or legally incapacitated.
- Unable or unwilling to undergo multiple venepuncture procedures or the patient has poor access to veins suitable for cannulation.
- Any other reason that, in the opinion of the investigator, would make participation in the study inadvisable.
- A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation within the last 5 years.
- A history of > 1 hospitalisation for COPD in the previous 1 year prior to screening.
- Evidence of cor pulmonale or clinically significant pulmonary hypertension.
- Requires routine treatment for COPD using one (or more) of the following therapies within the 6 weeks before screening or prior to randomisation: Oral Beta-2 agonists Methyl xanthines Phosphodiesterase (PDE) inhibitors Oral leukotriene inhibitors Oral or parenteral glucocorticoids Antibiotic therapies for acute infections (Note: chronic antibiotic use for prophylaxis, e.g. macrolides, is acceptable).
- Other respiratory disorders: Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, known alpha-1 antitrypsin deficiency or other active pulmonary diseases other than COPD.
- Patients with a history of chronic uncontrolled disease including, but not limited to, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematologic, urologic, immunologic, or ophthalmic diseases that, in the opinion of the investigator, would make participation in the study inadvisable.
- Patients with a history of sleep apnoea requiring non-invasive ventilation or supplemental oxygen during sleep.
- Previous lung resection or lung reduction surgery.
- Active participation in a pulmonary rehabilitation program.
- Has had major surgery within 6 weeks prior to screening or prior to randomisation.
- A disclosed history, or one known to the Investigator, of significant noncompliance in previous investigational studies or with prescribed medications.
- History of unstable or uncontrolled hypertension or has been diagnosed with hypertension in last 3 months prior to screening or prior to randomisation.
- Requires supplemental oxygen, even on an occasional basis.
- Received a live vaccine within 6 weeks prior to screening or prior to randomisation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medicines Evaluation Unit Ltd.
Manchester, Wythenshawe, M23 9QZ
About this study
Official title: A Phase 1b 3-way Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Once Daily Doses of PUR1800 in Adult Patients With Stable Chronic Obstructive Pulmonary Disease
This is a randomised, placebo-controlled, double-blind 3-way crossover study in which PUR1800, or placebo is dosed daily for 14 consecutive days in adult subjects with stable COPD over three discrete TPs. Subjects will be randomised to one of the following 3 treatment sequences:
Sequence Period 1 Period 2 Period 3
Read more
- Placebo PUR1800 250 μg PUR1800 500 μg
- PUR1800 250 μg Placebo PUR1800 500 μg
- PUR1800 250 μg PUR1800 500 μg Placebo
Since this is the first study in humans in which the iSPERSE formulation is being administered, the 3 treatment sequences are designed in order to ensure that the lower dose of PUR1800 (250 μg) is administered prior to the administration of the higher dose of PUR1800 (500 μg).
Read the detailed description
The study design is as follows
Informed Consent: Before any study specific procedures are conducted or study requirements are expected of a patient, the patient must review and sign an IEC-approved informed consent form.
Screening: Subjects will be screened for eligibility to participate in the study within 28 days before randomisation (i.e. TP1, Day 1).
Treatment Periods:
Period 1: On Day 1 all subjects who are eligible for entry into the study will be randomised to 1 of 3 treatment sequences and receive either placebo or the lowest nominal dose of PUR1800 (PUR1800 250 μg) for 14 consecutive days.
Period 2: Following a washout period of at least 28 days after the completion of Period 1 dosing, subjects will receive a treatment other than what the subject received during Period 1 for 14 consecutive days.
Period 3: Following a washout period of at least 28 days after the completion of Period 2 dosing, subjects will receive the treatment that the subject had not received during Periods 1 or 2 (either placebo or PUR1800, 500 μg) for 14 consecutive days.
End of Study (EOS): Subjects will return to the study site 28 days after the last dose of the last TP (or in the event of early withdrawal after the last dose received, if possible) for an EOS visit. Unscheduled visits are permitted at the discretion of the investigator.
- Being tested
- Placebo Comparator, PUR1800 250 ug, PUR1800 500 ug
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ComparatorDrug
The placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning.
PUR1800 250 ugDrug
The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 250 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning.
PUR1800 500 ugDrug
The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 500 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning. Receives: Drug: Placebo Comparator |
| PUR1800 250 μg | Active comparator | The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to 250 μg and 500 μg nominal dose strengths of RV1162. Subjects will receive 14 doses administered once daily in the morning. Receives: Drug: PUR1800 250 ug |
| PUR1800 500 μg | Active comparator | The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to 250 μg and 500 μg nominal dose strengths of RV1162. Subjects will receive 14 doses administered once daily in the morning. Receives: Drug: PUR1800 500 ug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events adult patients with stable COPD.
Review of adverse events
Measured: Day 1 through Day 28
Incidence of intraday FEV1 declines (from pre-dose to post-dose) of ≥10%, ≥15%, and ≥20% adult patients with stable COPD.
Review of spirometry data
Measured: Day 1 through Day 28
Respiratory rate
Breaths per minute
Measured: Day 1 through Day 28
Blood presuure
Systolic pressure over diastolic pressure
Measured: Day 1 through Day 28
Heart rate
Beats per minute
Measured: Day 1 through Day 28
Oxygen saturation
As a percentage
Measured: Day 1 through Day 28
Medical history findings
Medical record review
Measured: Day 1 through Day 28
Physical examination findings
Physician's notes
Measured: Day 1 through Day 28
Clinical laboratory parameters
Lab reports with any out of range results flagged
Measured: Day 1 through Day 28
12-Lead ECG findings
ECG report and tracing
Measured: Day 1 through Day 28
Occurrence of PEFR decline of ≥ 30% from the established baseline PEFR
Review of spirometry data
Measured: Day 1 through Day 28
Occurrence of administration of more than 12 inhalations of salbutamol per day over two consecutive days
Review of concomitant medications administered
Measured: Day 1 through Day 28
Secondary outcomes (8)
AUC0-t
Derived from plasma PK samples taken
Measured: Day 1 through Day 14
AUCinf inhaled PUR1800 in adult patients with stable COPD.
Derived from plasma PK samples taken
Measured: Day 1 through Day 14
CL
Derived from plasma PK samples taken
Measured: Day 1 through Day 14
Vss
Derived from plasma PK samples taken
Measured: Day 1 through Day 14
t1/2
Derived from plasma PK samples taken
Measured: Day 1 through Day 14
Cmax
Derived from plasma PK samples taken
Measured: Day 1 through Day 14
tmax
Derived from plasma PK samples taken
Measured: Day 1 through Day 14
Accumulation factor
Derived from plasma PK samples taken
Measured: Day 1 through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start4 Jan 2021
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- PUR1800, or placebo is dosed daily for 14 consecutive days in adult subjects with stable COPD over three discrete TPs. Subjects will be randomised to one of the following 3 treatment sequences: Sequence Period 1 Period 2 Period 3 1. Placebo PUR1800 250 μg PUR1800 500 μg 2. PUR1800 250 μg Placebo PUR1800 500 μg 3. PUR1800 250 μg PUR1800 500 μg Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, Prof, Principal investigator, The Medicines Evaluation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759807
- Sponsor's protocol ID
- 601-0016
- Status last verified
- Jun 2022
- First submitted
- 1 Feb 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b 3-way Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Once Daily Doses of PUR1800 in Adult Patients With Stable Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04759807
- Acronym / sponsor ID
- 601-0016
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised, placebo-controlled, double-blind 3-way crossover study in which PUR1800, or placebo is dosed daily for 14 consecutive days in adult subjects with stable COPD over three discrete TPs. Subjects will be randomised to one of the following 3 treatment sequences:
Sequence Period 1 Period 2 Period 3
- Placebo PUR1800 250 μg PUR1800 500 μg
- PUR1800 250 μg Placebo PUR1800 500 μg
- PUR1800 250 μg PUR1800 500 μg Placebo
Since this is the first study in humans in which the iSPERSE formulation is being administered, the 3 treatment sequences are designed in order to ensure that the lower dose of PUR1800 (250 μg) is administered prior to the administration of the higher dose of PUR1800 (500 μg).
Detailed description
The study design is as follows
Informed Consent: Before any study specific procedures are conducted or study requirements are expected of a patient, the patient must review and sign an IEC-approved informed consent form.
Screening: Subjects will be screened for eligibility to participate in the study within 28 days before randomisation (i.e. TP1, Day 1).
Treatment Periods:
Period 1: On Day 1 all subjects who are eligible for entry into the study will be randomised to 1 of 3 treatment sequences and receive either placebo or the lowest nominal dose of PUR1800 (PUR1800 250 μg) for 14 consecutive days.
Period 2: Following a washout period of at least 28 days after the completion of Period 1 dosing, subjects will receive a treatment other than what the subject received during Period 1 for 14 consecutive days.
Period 3: Following a washout period of at least 28 days after the completion of Period 2 dosing, subjects will receive the treatment that the subject had not received during Periods 1 or 2 (either placebo or PUR1800, 500 μg) for 14 consecutive days.
End of Study (EOS): Subjects will return to the study site 28 days after the last dose of the last TP (or in the event of early withdrawal after the last dose received, if possible) for an EOS visit. Unscheduled visits are permitted at the discretion of the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- PUR1800, or placebo is dosed daily for 14 consecutive days in adult subjects with stable COPD over three discrete TPs. Subjects will be randomised to one of the following 3 treatment sequences: Sequence Period 1 Period 2 Period 3 1. Placebo PUR1800 250 μg PUR1800 500 μg 2. PUR1800 250 μg Placebo PUR1800 500 μg 3. PUR1800 250 μg PUR1800 500 μg Placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo ComparatorThe placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning. |
| PUR1800 250 μg | Active comparator | Drug: PUR1800 250 ugThe PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to 250 μg and 500 μg nominal dose strengths of RV1162. Subjects will receive 14 doses administered once daily in the morning. |
| PUR1800 500 μg | Active comparator | Drug: PUR1800 500 ugThe PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to 250 μg and 500 μg nominal dose strengths of RV1162. Subjects will receive 14 doses administered once daily in the morning. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female patients aged 40 to 75 years of age with a body mass index
- ≥ 17 and ≤ 35 kg/m2.
- Female patients must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method (See Section 9.4.1).
- Male patients with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success or use highly effective contraception together with their female partner(s) (See Section 9.4.1).
- Female patients must agree not to donate ova/oocytes during the study and for 30 days after the last dose of IMP.
Key exclusion criteria (36 listed)
- Upper or lower respiratory tract infection within 6 weeks prior to screening or prior to randomisation.
- COPD exacerbation requiring oral steroids and/or antibiotics, within the 6 weeks prior to screening or prior to randomisation.
- Clinically significant abnormal laboratory values at screening that, in the opinion of the investigator would make the patient inappropriate for the study or put the patient at undue risk, specifically liver function tests (LFTs: aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transferase [GGT], total bilirubin) >3 x upper limit of normal (ULN); hemoglobin <10 gm/dL; absolute neutrophil count (ANC) <1000; white blood cells (WBC) >20,000; Platelets <100,000 and >500,000; prothrombin time (PT) >14 seconds.
- QTcF of >450 msec in males or >470 msec in females on any of the three individual ECG measurements at screening or prior to randomisation.
- History of drug or alcohol abuse within the past 2 years prior to screening or prior to randomisation.
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 |
|---|---|---|
| Placebo ComparatorThe placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning. | Drug | Placebo |
| PUR1800 250 ugThe PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 250 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning. | Drug | PUR1800 250 μg |
| PUR1800 500 ugThe PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 500 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning. | Drug | PUR1800 500 μg |
Primary outcome
Incidence of treatment-emergent adverse events adult patients with stable COPD.
Time frame: Day 1 through Day 28
Review of adverse events
Incidence of intraday FEV1 declines (from pre-dose to post-dose) of ≥10%, ≥15%, and ≥20% adult patients with stable COPD.
Time frame: Day 1 through Day 28
Review of spirometry data
Respiratory rate
Time frame: Day 1 through Day 28
Breaths per minute
Blood presuure
Time frame: Day 1 through Day 28
Systolic pressure over diastolic pressure
Heart rate
Time frame: Day 1 through Day 28
Beats per minute
Oxygen saturation
Time frame: Day 1 through Day 28
As a percentage
Medical history findings
Time frame: Day 1 through Day 28
Medical record review
Physical examination findings
Time frame: Day 1 through Day 28
Physician's notes
Clinical laboratory parameters
Time frame: Day 1 through Day 28
Lab reports with any out of range results flagged
12-Lead ECG findings
Time frame: Day 1 through Day 28
ECG report and tracing
Occurrence of PEFR decline of ≥ 30% from the established baseline PEFR
Time frame: Day 1 through Day 28
Review of spirometry data
Occurrence of administration of more than 12 inhalations of salbutamol per day over two consecutive days
Time frame: Day 1 through Day 28
Review of concomitant medications administered
8 secondary outcomes
AUC0-t
Time frame: Day 1 through Day 14
AUCinf inhaled PUR1800 in adult patients with stable COPD.
Time frame: Day 1 through Day 14
CL
Time frame: Day 1 through Day 14
Vss
Time frame: Day 1 through Day 14
t1/2
Time frame: Day 1 through Day 14
Cmax
Time frame: Day 1 through Day 14
tmax
Time frame: Day 1 through Day 14
Accumulation factor
Time frame: Day 1 through Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
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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.
Dave Singh, Prof principal investigator
The Medicines Evaluation Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PUR1800 250 ug and PUR1800 500 ug in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pulmatrix Inc. at 1 site 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 16 inclusion and 36 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: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-emergent adverse events adult patients with stable COPD. (time frame: Day 1 through Day 28). The study lists 12 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 27 Jun 2022.