Chronic Obstructive Pulmonary DiseasePhase 1/2NCT01348555
Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162
A Phase 1/2 study testing Bronchodilatator in people with Chronic Obstructive Pulmonary Disease, run by Pierre Fabre Medicament at 2 sites in 2 countries.
Trial summary
Pulmonary administered anticholinergic agents have shown their importance in the chronic obstructive pulmonary disease (COPD) management to reduce morbidity, disability and mortality. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bronchodilatator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2011to Jul 2012
- Phase
- Phase 1/2
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male gender
- Age between 18 to 50 years included,
- 18 ≤ Body Mass Index (BMI) < 30 kg/m²,
- Who had given their written consent for their participation in the study,
- Who, in the judgement of the Investigator, are likely to be compliant during the study,
- Registered with a social security insurance system.
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- Aged 40 to 65 years-old,
- 18 ≤ BMI < 35 kg/m2,
- Smokers ≥ 10 packs / year,
- Moderate to severe COPD
- Registered with a social security insurance system.
Who cannot join
- History of asthma or significant respiratory disorder,
- History of allergic rhinitis,
- Upper respiratory tract infection in the last month,
- Blood eosinophil count ≥ 600/μL,
- Epilepsy, narrow angle glaucoma, prostatic hypertrophy or bladder neck obstruction,
- Abnormal spirography,
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- Respiratory tract infection in the last 6 weeks,
- Asthma or significant respiratory disorder other than COPD,
- Allergic rhinitis,
- Blood eosinophil count ≥ 600/μL,
- Epilepsy, narrow angle glaucoma, moderate to severe prostatic hypertrophy or bladder neckobstruction,
- Myocardial infarction within the previous 6 months, heart failure or serious cardiac arrhythmia,
- Moderate to severe renal impairment,
- Moderate to severe hepatic impairment
- Use of short-acting b-agonist,
- Use of anticholinergics
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Pulmonary administered anticholinergic agents have shown their importance in the chronic obstructive pulmonary disease (COPD) management to reduce morbidity, disability and mortality. To date, the recommended treatment of moderate to severe COPD patients consist in the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a medical need in new product that could exhibit both anti-inflammatory and strong bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.
Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound and could bring new option in the treatment of this life-threatening disease.
Read the detailed description
This study has two parts. Part A will be conducted in 72 healthy volunteers. Part B will be conducted in 20 patients diagnosed with COPD.
Part A The primary objective of this part of the study is to assess the local tolerability of escalating doses of V0162 in male healthy volunteers.
Part B The primary objective of this part of the study is to assess the bronchodilator properties of V0162 at the maximal tolerated dose (determined in Part A) in COPD patients.
In addition, pharmacokinetics and vital sign including ECG will be determined.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Bronchodilatator
- 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.
BronchodilatatorDrug
BronchodilatatorDrug
| Study group | Role | What they receive |
|---|---|---|
| V0162 | Experimental | Not described Receives: Drug: Bronchodilatator |
| Placebo | Placebo comparator | Not described Receives: Drug: Bronchodilatator |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the local tolerability of V0162 in healthy male volunteers
Monitoring of parameters of the pulmonary function: spirometry measurements. Assessment of respiratory system symptoms: using a 4-point scale and assessment of dyspnoea by VAS. Monitoring for the occurrence of AEs.
Changes in physical examination: vital signs (blood pressure and pulse rate), holter-ECG and clinical laboratory tests (biochemistry, haematology, urinalysis).
Measured: change from baseline in the local tolerability over 72 h after dosing
Secondary outcomes (2)
To determine the PK parameters of V0162 in healthy male volunteers
Pharmacokinetics: evaluation of the PK parameter of V0162 (measured by area under the plasma concentration-time curve (AUC)) after oral administration and of the dose proportionality.
Measured: 0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing
To assess the bronchodilator properties of V0162 in COPD
Monitoring of parameters of the pulmonary function through plethysmography measurements.
Measured: 0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS Life Sciences, a division of SGS Belgium NV
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348555
- Sponsor's protocol ID
- V00162 PI 101 1A
- Status last verified
- May 2011
- First submitted
- 13 Apr 2011
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Devillier P, Garrigue E, D'Auzers G, Monjotin N, Similowski T, Clerc T. V0162 a new long-acting bronchodilator for treatment of chronic obstructive lung diseases: preclinical and clinical results. Respir Res. 2015 Jun 8;16(1):68. doi: 10.1186/s12931-015-0227-1.
PubMed 26050967
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162
- ClinicalTrials.gov ID
- NCT01348555
- Acronym / sponsor ID
- V00162 PI 101 1A
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Collaborators
- SGS Life Sciences, a division of SGS Belgium NV
- Study start
- Apr 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 5 May 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.
Pulmonary administered anticholinergic agents have shown their importance in the chronic obstructive pulmonary disease (COPD) management to reduce morbidity, disability and mortality. To date, the recommended treatment of moderate to severe COPD patients consist in the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a medical need in new product that could exhibit both anti-inflammatory and strong bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.
Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound and could bring new option in the treatment of this life-threatening disease.
Detailed description
This study has two parts. Part A will be conducted in 72 healthy volunteers. Part B will be conducted in 20 patients diagnosed with COPD.
Part A The primary objective of this part of the study is to assess the local tolerability of escalating doses of V0162 in male healthy volunteers.
Part B The primary objective of this part of the study is to assess the bronchodilator properties of V0162 at the maximal tolerated dose (determined in Part A) in COPD patients.
In addition, pharmacokinetics and vital sign including ECG will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V0162 | Experimental | Drug: Bronchodilatator |
| Placebo | Placebo comparator | Drug: Bronchodilatator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male gender
- Age between 18 to 50 years included,
- 18 ≤ Body Mass Index (BMI) < 30 kg/m²,
- Who had given their written consent for their participation in the study,
- Who, in the judgement of the Investigator, are likely to be compliant during the study,
Key exclusion criteria (16 listed)
- History of asthma or significant respiratory disorder,
- History of allergic rhinitis,
- Upper respiratory tract infection in the last month,
- Blood eosinophil count ≥ 600/μL,
- Epilepsy, narrow angle glaucoma, prostatic hypertrophy or bladder neck obstruction,
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 |
|---|---|---|
| Bronchodilatator | Drug | V0162 |
| Bronchodilatator | Drug | Placebo |
Primary outcome
To assess the local tolerability of V0162 in healthy male volunteers
Time frame: change from baseline in the local tolerability over 72 h after dosing
Monitoring of parameters of the pulmonary function: spirometry measurements. Assessment of respiratory system symptoms: using a 4-point scale and assessment of dyspnoea by VAS. Monitoring for the occurrence of AEs. Changes in physical examination: vital signs (blood pressure and pulse rate), holter-ECG and clinical laboratory tests (biochemistry, haematology, urinalysis).
2 secondary outcomes
To determine the PK parameters of V0162 in healthy male volunteers
Time frame: 0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing
To assess the bronchodilator properties of V0162 in COPD
Time frame: 0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing
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 4 Jun 2013.
- Derived from this study: PubMed 26050967Devillier P, Garrigue E, D'Auzers G, Monjotin N, Similowski T, Clerc T. V0162 a new long-acting bronchodilator for treatment of chronic obstructive lung diseases: preclinical and clinical results. Respir Res. 2015 Jun 8;16(1):68. doi: 10.1186/s12931-015-0227-1.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bronchodilatator in people with Chronic Obstructive Pulmonary Disease, run by Pierre Fabre Medicament at 2 sites in 2 countries.
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 11 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: finished, as of the sponsor's last update on 4 Jun 2013. 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 Belgium, France. 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 combined 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.
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?
To assess the local tolerability of V0162 in healthy male volunteers (time frame: change from baseline in the local tolerability over 72 h after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01348555, which also lists 1 linked publication.
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 4 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.