Chronic Obstructive Pulmonary DiseasePhase 2NCT01475292
A Study to Investigate How Safe and Well Tolerated RV568 is in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing RV568 in people with Chronic Obstructive Pulmonary Disease, run by Respivert Ltd at 2 sites in United Kingdom.
Trial summary
RV568 is being developed as a possible treatment of diseases such as smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD) and asthma. The main purpose of this study is to examine the safety of RV568 in COPD 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?
- RV568
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2011to Apr 2012
- Phase
- Phase 2
- 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
- Male or female aged 40-75 years inclusive at the time of signing the informed consent.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines, with symptoms compatible with COPD for at least 1 year prior to screening.
- Severity of Disease: subjects who conform to the current severity classification for GOLD Stage II/III disease in terms of post-bronchodilator spirometry at screening (Post-salbutamol FEV1/FVC ratio of ≤ 0.70 and post-salbutamol FEV1 ≥ 40 % and ≤ 80 % of predicted normal values calculated using ECCS reference equations)
- Demonstrated ability to use the I-neb AAD system at screening.
- Subject is a current or previous smoker with a smoking history of ≥ 10 pack years
Who cannot join
- A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation
- A history of > 1 hospitalisation for COPD in the previous 2 years prior to screening.
- Evidence of cor pulmonale or clinically significant pulmonary hypertension or chronic (in the opinion of the Investigator) use of oxygen.
- Upper or lower respiratory tract infection, including exacerbation of COPD, within 6 weeks of screening.
- Other respiratory disorders: Subjects with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases or other active pulmonary diseases.
- Subjects with a history of chronic disease including, but not limited to, sleep apnoea, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant.
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- Previous lung resection or lung reduction surgery.
- Pregnant or nursing females.
- Any abnormal or clinically significant ECG or laboratory values that the Investigator considers would put the subject at risk through participation. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included if the Investigator and the sponsor representative agree it is unlikely to introduce additional risk factors and will not interfere with study procedures.
- ALT > 2 x ULN at the screening visit.
- A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody result, or positive test for HIV antibody at the screening visit (or within the 3 months prior to screening).
- Positive test for drugs of abuse at screening that cannot be satisfactorily explained by a prescription history (e.g., recent use of codeine tablets).
- History of alcohol abuse within the previous 6 months
- Has had major surgery, (requiring general anesthesia) within 6 weeks before the screening visit, or will not have fully recovered from surgery, or planned surgery through the end of the study
- Participated in any other clinical study of an NCE within 3 months, or in a study of a marketed drug within 1 month (or within 5 half-lives of the NCE or marketed drug, whichever is the longest) of first dose; or has participated in 4 studies in the previous 12 months.
- A disclosed history, or one known to the Investigator, of significant noncompliance in previous investigational studies or with prescribed medications.
- Allergy to any of the active or inactive ingredients in the study medication, or history of drug, or other allergy that, in the opinion of the Investigator or RespiVert medical monitor, would contraindicate their participation.
- Donation of blood in excess of 500 mL within a 3 month period prior to dosing, or if study participation would result in blood loss in excess of 500 mL in a 3 month period.
- Subject is mentally or legally incapacitated.
- Has any condition or are taking a medication that, in the opinion of the Investigator, would make participation not be in the best interest (i.e., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
- Is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the Investigator.
- Any other reason that the Investigator considers makes the subject unsuitable to participate.
- Subject has a history of unstable, or uncontrolled hypertension, or has been diagnosed with hypertension in last 6 months.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Quintiles Drug Research Unit at Guy's Hospital
London
Medicines Evaluation Unit (MEU)
Manchester
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Tolerability of Treatment With Repeat Doses of Inhaled RV568 in Patients With COPD
RV568 is being developed as a possible treatment of diseases such as smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD) and asthma.
The main purpose of this study is to examine the safety of RV568 in COPD patients. Two dose strengths of RV568 and a placebo will be tested in this study, which will be given by inhaling a liquid suspension from a nebuliser once a day for 2 weeks.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- RV568, Placebo
- Keywords
- COPD
- 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.
RV568Drug
RV568 50 ug administered via a nebuliser once daily for 14 days
RV568Drug
RV568 100 ug administered via a nebuliser once daily for 14 days
PlaceboDrug
Placebo administered via a nebuliser once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| RV568 treatment group low dose | Experimental | Not described Receives: Drug: RV568 |
| RV568 treatment group high dose | Experimental | Not described Receives: Drug: RV568 |
| Placebo treatment group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Assessment of vital signs, ECG, adverse event assessment, clinical laboratory screening and spirometry.
Measured: 28 days
Secondary outcomes (4)
Plasma RV568 levels
Measured: 0,15,30,45 min and 1,2,4,6,8,10,12 & 24 hours post dose on Days 1 & 14, 0,1 & 2 hours post dose on Day 7 and one time point on Days 4, 21 & 28
Assessment of lung function using a body plethysmograph
Measured: 2 week treatment period
Assessment of markers of inflammation in sputum
Measured: 2 week treatment period
Assessment of markers of inflammation in blood
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionApr 2012
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivert Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonard Siew, MD, Principal investigator, Quintiles Drug Research Unit at Guy's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475292
- Sponsor's protocol ID
- RVH006
- Other IDs
- 2011-004031-31
- Status last verified
- May 2012
- First submitted
- 16 Nov 2011
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. 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 and Tolerability of Treatment With Repeat Doses of Inhaled RV568 in Patients With COPD
- ClinicalTrials.gov ID
- NCT01475292
- Acronym / sponsor ID
- RVH006
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Nov 2011 (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.
RV568 is being developed as a possible treatment of diseases such as smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD) and asthma.
The main purpose of this study is to examine the safety of RV568 in COPD patients. Two dose strengths of RV568 and a placebo will be tested in this study, which will be given by inhaling a liquid suspension from a nebuliser once a day for 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RV568 treatment group low dose | Experimental | Drug: RV568 |
| RV568 treatment group high dose | Experimental | Drug: RV568 |
| Placebo treatment group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged 40-75 years inclusive at the time of signing the informed consent.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines, with symptoms compatible with COPD for at least 1 year prior to screening.
- Severity of Disease: subjects who conform to the current severity classification for GOLD Stage II/III disease in terms of post-bronchodilator spirometry at screening (Post-salbutamol FEV1/FVC ratio of ≤ 0.70 and post-salbutamol FEV1 ≥ 40 % and ≤ 80 % of predicted normal values calculated using ECCS reference equations)
- Demonstrated ability to use the I-neb AAD system at screening.
Key exclusion criteria (23 listed)
- A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation
- A history of > 1 hospitalisation for COPD in the previous 2 years prior to screening.
- Evidence of cor pulmonale or clinically significant pulmonary hypertension or chronic (in the opinion of the Investigator) use of oxygen.
- Upper or lower respiratory tract infection, including exacerbation of COPD, within 6 weeks of screening.
- Other respiratory disorders: Subjects with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases or other active 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 |
|---|---|---|
| RV568RV568 50 ug administered via a nebuliser once daily for 14 days | Drug | RV568 treatment group low dose |
| RV568RV568 100 ug administered via a nebuliser once daily for 14 days | Drug | RV568 treatment group high dose |
| PlaceboPlacebo administered via a nebuliser once daily for 14 days | Drug | Placebo treatment group |
Primary outcome
Safety and tolerability
Time frame: 28 days
Assessment of vital signs, ECG, adverse event assessment, clinical laboratory screening and spirometry.
4 secondary outcomes
Plasma RV568 levels
Time frame: 0,15,30,45 min and 1,2,4,6,8,10,12 & 24 hours post dose on Days 1 & 14, 0,1 & 2 hours post dose on Day 7 and one time point on Days 4, 21 & 28
Assessment of lung function using a body plethysmograph
Time frame: 2 week treatment period
Assessment of markers of inflammation in sputum
Time frame: 2 week treatment period
Assessment of markers of inflammation in blood
Time frame: 28 days
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 3 May 2012.
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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.
Leonard Siew, MD principal investigator
Quintiles Drug Research Unit at Guy's Hospital
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 RV568 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 6 inclusion and 23 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 3 May 2012. 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. 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 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?
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?
Safety and tolerability (time frame: 28 days). 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 3 May 2012.