AsthmaPhase 2NCT01951222
Bronchodilator Properties and Safety in Asthma
A Phase 2 study testing V0162 in people with Asthma, run by Pierre Fabre Medicament at 1 site in Germany.
Trial summary
Recent large clinical studies have demonstrated the interest of LAMA therapy in the management of asthma, when compared to LABA. V0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in COPD patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- V0162
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Apr 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years-old.
- 18 ≤ BMI <30 kg/m².
- Clinical history consistent asthma, in the judgement of the investigator.
- Asthma controlled or partly controlled according to GINA 2012 criteria:
- Asthma treated by ICS and LABA (fixed-dose combination or free combination) at stable dose for at least 3 months.
- Able to replace the usual ICS and LABA therapy by ICS at the usual dose regimen and salbutamol as needed.
- Able to stop salbutamol at least 6 hours before a study visit.
- Able to perform at least 3 acceptable and reproducible FEV1 and FVC measurements according to ERS/ATS 2005 recommendations.
Who cannot join
- Clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, COPD, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
- Upper or lower respiratory tract infection within 4 weeks.
- Exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
- Current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
- Intolerance to salbutamol.
- Intolerance to tiotropium (or any other atropine-derived compound).
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- Intolerance to one of the ingredients of the study product
- Severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, gastrointestinal obstruction, moderate to severe prostatic hypertrophy, bladder neck obstruction.
- Any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator.
- Clinically relevant physical examination abnormality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.
Recent large clinical studies have demonstrated the interest of LAMA therapy in the management of asthma, when compared to LABA.
V0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in COPD patients. Secondary properties of V0162 (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound and could bring option in the treatment obstructive lung disease. The objective of the study is to assess the bronchodilator properties of V0162 during 8 days in adult patients with asthma usually treated with ICS and LABA. The study is a randomised, double-blind, placebo-controlled, 3-period crossover, preceded by an open-label active-control period before randomisation.
- Conditions
- Asthma
- Being tested
- V0162, Placebo
- Keywords
- Asthma, COPD, broncodilator, airway, lung, inhalation, antimuscarinic
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0162Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| V0162 dose1 | Experimental | Not described Receives: Drug: V0162 |
| V0162 dose2 | Experimental | Not described Receives: Drug: V0162 |
| placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalised AUC 0-24h of FEV1 at day 8 of treatment period
FEV1 assessed by spirometry
Measured: At the 8th day of treatment period
Secondary outcomes (10)
Parameters of the pulmonary function
as well as the following criteria assessed the first day and the last day of each treatment period and the difference between the last day and the first day within each treatment periodadjusted for placebo effect:
- the normalised AUC0-9h of FEV1 (L),
- the normalised AUC0-12h of FEV1 (L),
- the peak of FEV1 (L) which is the higher observed post-dosing value,
- the trough of FEV1 (L) which is the last measurement before the next dosing (i.e. t24h),
- the normalised AUC0-9h,AUC0-12h, AUC0-24h, peak and trough of FVC, MEF25, MEF50, MEF75, and MEF25-75.
Measured: Day 1 and Day 8 of treatment period
PEF
PEF measured using a peak-flow meter
Measured: Morning and evening from Day 1 to day 8 of treatment period
Dyspnoea
The criteria will be the normalised AUC0-9h,AUC0-12h, and AUC0-24h of the dyspnoea measurements(mm) assessed the first and the last day of each treatment period, and the difference between the last and the first day within each treatment period.
Measured: Day 1 to Day 8 of treatment period
Vital signs
Measured: Visit 2, and at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 24 h post-dose during the in-clinic visits) and at Visit 11
12-lead standard ECG
Measured: at Visit 1, at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 1 h, 6 h, 24 h post-dose) and at Visit 11
Holter-ECG
Measured: At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose
Clinical laboratory tests (haematology, biochemistry, urinalysis)
Measured: Visit 1 and Visit 11
AEs
Measured: From Visit 1 to Visit 11
Normalised AUC 0-24h of FEV1 at Day 1 of treatment period
FEV1 assessed by spirometry
Measured: The first day of treatment period
Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1
FEV1 assessed by spirometry
Measured: Difference between day 8 and first day of treatement period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951222
- Sponsor's protocol ID
- 2013-002517-35
- Status last verified
- Sep 2013
- First submitted
- 5 Sep 2013
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.
- ClinicalTrials.gov ID
- NCT01951222
- Acronym / sponsor ID
- 2013-002517-35
- Conditions
- Asthma
- Keywords
- Asthma, COPD, broncodilator, airway, lung, inhalation, antimuscarinic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Sep 2013 (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.
Recent large clinical studies have demonstrated the interest of LAMA therapy in the management of asthma, when compared to LABA.
V0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in COPD patients. Secondary properties of V0162 (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound and could bring option in the treatment obstructive lung disease. The objective of the study is to assess the bronchodilator properties of V0162 during 8 days in adult patients with asthma usually treated with ICS and LABA. The study is a randomised, double-blind, placebo-controlled, 3-period crossover, preceded by an open-label active-control period before randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| V0162 dose1 | Experimental | Drug: V0162 |
| V0162 dose2 | Experimental | Drug: V0162 |
| placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 to 65 years-old.
- 18 ≤ BMI <30 kg/m².
- Clinical history consistent asthma, in the judgement of the investigator.
- Asthma controlled or partly controlled according to GINA 2012 criteria:
- Asthma treated by ICS and LABA (fixed-dose combination or free combination) at stable dose for at least 3 months.
Key exclusion criteria (10 listed)
- Clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, COPD, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
- Upper or lower respiratory tract infection within 4 weeks.
- Exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
- Current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
- Intolerance to salbutamol.
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 |
|---|---|---|
| V0162 | Drug | V0162 dose1, V0162 dose2 |
| Placebo | Other | placebo |
Primary outcome
Normalised AUC 0-24h of FEV1 at day 8 of treatment period
Time frame: At the 8th day of treatment period
FEV1 assessed by spirometry
10 secondary outcomes
Parameters of the pulmonary function
Time frame: Day 1 and Day 8 of treatment period
PEF
Time frame: Morning and evening from Day 1 to day 8 of treatment period
Dyspnoea
Time frame: Day 1 to Day 8 of treatment period
Vital signs
Time frame: Visit 2, and at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 24 h post-dose during the in-clinic visits) and at Visit 11
12-lead standard ECG
Time frame: at Visit 1, at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 1 h, 6 h, 24 h post-dose) and at Visit 11
Holter-ECG
Time frame: At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose
Clinical laboratory tests (haematology, biochemistry, urinalysis)
Time frame: Visit 1 and Visit 11
AEs
Time frame: From Visit 1 to Visit 11
Normalised AUC 0-24h of FEV1 at Day 1 of treatment period
Time frame: The first day of treatment period
Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1
Time frame: Difference between day 8 and first day of treatement period
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 17 Sep 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing V0162 in people with Asthma, run by Pierre Fabre Medicament at 1 site in Germany.
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 8 inclusion and 10 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 17 Sep 2014. 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 Germany. 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?
Normalised AUC 0-24h of FEV1 at day 8 of treatment period (time frame: At the 8th day of treatment period). 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 17 Sep 2014.