Chronic Obstructive Pulmonary DiseasePhase 1NCT02140346
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Doses of RV1729 for 28 Days in Patients With COPD
A Phase 1 study testing RV1729 28 day repeat dose in people with Chronic Obstructive Pulmonary Disease, run by Respivert Ltd at 2 sites in United Kingdom.
Trial summary
RV1729 is a new medicine being developed for the potential treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The objective of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics repeat doses of RV1729 in patients… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- RV1729 28 day repeat dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Aug 2014to Jul 2015
- 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
- Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Be a man or a woman of non-child-bearing potential aged 40 to 75 years
- Women of non-childbearing potential must be either amenorrhoeic >1 year with an appropriate clinical profile or permanently sterilised
- Women must agree not to donate eggs (ova, oocytes) from Screening until at least 6 months after the final dose of study medication
- Men must be willing to use one form of contraception (with documented failure rate less than 1%) and agree not to donate sperm from Screening to 90 days post last dose of study agent
- Chronic obstructive pulmonary disease diagnosis with symptoms compatible with COPD for at least 1 year before Screening.
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- Severity of disease: subjects who conform to the current severity classification for Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2014) Grade II/III
- On a background therapy of inhaled steroid with or without the addition of long-acting bronchodilators (either long-acting beta agonists [LABAs] or long-acting muscarinic antagonists [LAMAs]).
- Be able to produce an acceptable induced sputum sample at the Screening visit.
- Capable of complying with all study restrictions and procedures including ability to use the study inhaler correctly.
- A current or previous smoker with a smoking history of ≥10 pack years.
- Have a 12 lead ECG recording consistent with normal cardiac function at the Screening visit and pre-dose Day 1
Who cannot join
- A history of life-threatening COPD including respiratory arrest, intensive care unit admission and/or requiring intubation.
- A history of more than one hospitalisation for COPD in the 2 years before Screening.
- Evidence of cor pulmonale, clinically significant pulmonary hypertension or chronic use of oxygen.
- Upper or lower respiratory tract infection, including exacerbation of COPD, requiring augmentation of therapy within 6 weeks of Screening.
- Other respiratory disorders: subjects with a history of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis or other chronic pulmonary diseases.
- A chest X-ray at Screening (or within 6 months prior to the Screening visit) showing abnormalities, which in the opinion of the Investigator are clinically significant and unrelated to COPD.
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- A history of chronic disease including, but not limited to, unstable or uncontrolled hypertension (or been diagnosed with hypertension in the 6 months before Screening), sleep apnoea, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, haematological, urological, immunological or ophthalmic diseases that the Investigator believes are clinically significant e.g., unstable and could impact subject safety by participation in the study.
- Previous lung resection or lung reduction surgery.
- Vital sign assessments outside the following ranges: for inclusion blood pressure (after the subject is supine for 10 minutes) must be between 100 and 160 mmHg systolic, inclusive, and between 55 and 100 mmHg diastolic; heart rate must be between 40-100 bpm. These criteria must be met at Screening, Day -1 and pre-dose on Day 1.
- Have a clinical abnormality or laboratory parameters outside the reference range at Screening or Day -1.
- Liver function test results (ALT, aspartate amino transferase and gamma glutamyl transferase) >2 x ULN (upper limit of normal) at Screening or on Day -1.
- Chronic liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus (HBV) infection or hepatitis C antibodies.
- Unable or unwilling to undergo multiple venepuncture procedures or the subject has poor access to veins suitable for cannulation.
- If a woman, has a positive serum pregnancy test at Screening.
- Definite or suspected history of drug or alcohol abuse within the previous 5 years.
- Positive test for alcohol or drugs of abuse, including cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines or barbiturates at Screening or on Day -1 or Day 1.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males, or >14 units for females.
- History of clinically significant allergies that, in the opinion of the Investigator would contraindicate their participation.
- Known allergy to the study drug or any of the excipients of the formulation or has previously been exposed to RV1729.
- 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.
- Received an experimental drug or used an experimental medical device within 3 months or within a period less than five times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled.
- Requires routine treatment for COPD using one (or more) of the therapies listed in the protocol within the 6 weeks before Screening.
- A disclosed history or one known to the Investigator, of significant non-compliance in previous investigational studies or with prescribed medications.
- Has had major surgery, (requiring general anaesthesia) within 6 weeks before the Screening visit, or will not have fully recovered from surgery, or has planned surgery from Screening through to the end of the study. Note: subjects with planned surgical procedures to be conducted under local anaesthesia may participate.
- 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.
- The subject is unable or unwilling to comply fully with the study protocol.
- The subject is mentally or legally incapacitated.
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Study site
Belfast, BT9 6AD
Study site
Manchester, M23 9QZ
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled RV1729 in Patients With COPD
RV1729 is a new medicine being developed for the potential treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The objective of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics repeat doses of RV1729 in patients with COPD for 28 days.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- RV1729 28 day repeat dose, RV1729 matching placebo 28 day repeat dose
- 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.
RV1729 28 day repeat doseDrug
Safety and tolerability of repeat doses
RV1729 matching placebo 28 day repeat doseDrug
Safety and tolerability of repeat doses
| Study group | Role | What they receive |
|---|---|---|
| 28 day repeat dose (low dose) | Experimental | Not described Receives: Drug: RV1729 28 day repeat dose; Drug: RV1729 matching placebo 28 day repeat dose |
| 28 day repeat dose (high dose) | Experimental | Not described Receives: Drug: RV1729 28 day repeat dose; Drug: RV1729 matching placebo 28 day repeat dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Assessment of the number of adverse events reported by subjects following dosing
Measured: 56 days
ECG assessment (12 lead ECG)
Change from pre-dose values
Measured: 56 days
Vital sign assessment (blood pressure and heart rate)
Change from pre-dose values
Measured: 56 days
Clinical laboratory assessments (blood and urine samples)
Change from pre-dose values
Measured: 56 days
Spirometry assessment (FEV1 & FVC)
Change from pre-dose values
Measured: 56 days
Use of rescue medication
Assessment of the number of occasions subjects are required to administer rescue medication
Measured: 29 days
Peak expiratory flow (PEF)
Change from pre-dose values
Measured: 56 days
Secondary outcomes (1)
Plasma RV1729 levels
Measured: Days 1, 14 & 28 - 9 samples per day; Days 7, 21, 26 and 27 - 1 sample per day; Days 31 to 56 - 5 samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivert Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liza O'Dowd, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140346
- Sponsor's protocol ID
- STN002
- Other IDs
- 2014-000089-23, 2014
- Status last verified
- Jul 2015
- First submitted
- 14 May 2014
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled RV1729 in Patients With COPD
- ClinicalTrials.gov ID
- NCT02140346
- Acronym / sponsor ID
- STN002
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 May 2014 (estimated)
- 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.
RV1729 is a new medicine being developed for the potential treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The objective of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics repeat doses of RV1729 in patients with COPD for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 28 day repeat dose (low dose) | Experimental | Drug: RV1729 28 day repeat dose, Drug: RV1729 matching placebo 28 day repeat dose |
| 28 day repeat dose (high dose) | Experimental | Drug: RV1729 28 day repeat dose, Drug: RV1729 matching placebo 28 day repeat dose |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- Be a man or a woman of non-child-bearing potential aged 40 to 75 years
- Women of non-childbearing potential must be either amenorrhoeic >1 year with an appropriate clinical profile or permanently sterilised
- Women must agree not to donate eggs (ova, oocytes) from Screening until at least 6 months after the final dose of study medication
- Men must be willing to use one form of contraception (with documented failure rate less than 1%) and agree not to donate sperm from Screening to 90 days post last dose of study agent
Key exclusion criteria (29 listed)
- A history of life-threatening COPD including respiratory arrest, intensive care unit admission and/or requiring intubation.
- A history of more than one hospitalisation for COPD in the 2 years before Screening.
- Evidence of cor pulmonale, clinically significant pulmonary hypertension or chronic use of oxygen.
- Upper or lower respiratory tract infection, including exacerbation of COPD, requiring augmentation of therapy within 6 weeks of Screening.
- Other respiratory disorders: subjects with a history of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis or other chronic pulmonary diseases.
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 |
|---|---|---|
| RV1729 28 day repeat doseSafety and tolerability of repeat doses | Drug | 28 day repeat dose (high dose), 28 day repeat dose (low dose) |
| RV1729 matching placebo 28 day repeat doseSafety and tolerability of repeat doses | Drug | 28 day repeat dose (high dose), 28 day repeat dose (low dose) |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: 56 days
Assessment of the number of adverse events reported by subjects following dosing
ECG assessment (12 lead ECG)
Time frame: 56 days
Change from pre-dose values
Vital sign assessment (blood pressure and heart rate)
Time frame: 56 days
Change from pre-dose values
Clinical laboratory assessments (blood and urine samples)
Time frame: 56 days
Change from pre-dose values
Spirometry assessment (FEV1 & FVC)
Time frame: 56 days
Change from pre-dose values
Use of rescue medication
Time frame: 29 days
Assessment of the number of occasions subjects are required to administer rescue medication
Peak expiratory flow (PEF)
Time frame: 56 days
Change from pre-dose values
1 secondary outcome
Plasma RV1729 levels
Time frame: Days 1, 14 & 28 - 9 samples per day; Days 7, 21, 26 and 27 - 1 sample per day; Days 31 to 56 - 5 samples
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 2 Jul 2015.
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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.
Liza O'Dowd, MD study director
Sponsor GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RV1729 28 day repeat dose in people with Chronic Obstructive Pulmonary Disease, run by Respivert Ltd 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 12 inclusion and 29 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 2 Jul 2015. 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 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 (time frame: 56 days). The study lists 7 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 2 Jul 2015.