Severe Chronic Obstructive Pulmonary DiseasePhase 4NebuadomNCT02103374
Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State
A Phase 4 study testing Atrovent + Bricanyl or Atrovent + Ventoline in people with Severe Chronic Obstructive Pulmonary Disease, run by University Hospital, Tours at 13 sites in France.
Trial summary
Design studies of nebulization in COPD does not respond adequately to the clinically relevant question: the intervention of administering nebulized bronchodilators at home it is likely to make a profit, compared to the standard optimized treatment as defined by the recommendations of the SPLF, patients with severe… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Chronic Obstructive Pulmonary Disease
- What is being tested?
- Atrovent + Bricanyl or Atrovent + Ventoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 13 sitesFrance
- Study dates
- Jan 2012to Dec 2015
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- COPD Patients stage 3 et 4
- Has not submitted an exacerbation in the 3 months preceding the pre-inclusion visit
- Weaned from tobacco for at least 6 months
- vaccinated against pneumococcal
- Have not been included in a pulmonary rehabilitation program during the 6 months preceding the screening visit inclusion
- Patient pre-included not showing exacerbation since the pre-inclusion visit
Who cannot join
- Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
- Patient with an indication of oxygen is expected in the coming year
- Progressive malignant disease known
- Patient under non-invasive ventilation (NIV) for less than 6 months or NIV provided in the following year
- Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
- Patients with severe cardiovascular disease
- Pregnancy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Service de Pneumologie
Amiens, 80054
Service de Pneumologie
Angers, 49033
Service de Pneumologie
Brest, 29609
Service de Pneumologie
Grenoble, 38043
Service de Pneumologie
Limoges, 87042
Service de Pneumologie
Nancy, 54511
Service de Pneumologie
Nantes, 44093
Service de Pneumologie
Orléans, 45067
Service de Pneumologie
Paris, 75004
Service de Pneumologie
Poitiers, 86000
Service de Pneumologie
Reims, 51100
Service de Pneumologie
Rouen, 76031
Service de Pneumologie
Tours, 37044
About this study
Design studies of nebulization in COPD does not respond adequately to the clinically relevant question: the intervention of administering nebulized bronchodilators at home it is likely to make a profit, compared to the standard optimized treatment as defined by the recommendations of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of profit in this context is based on criteria of dyspnea, quality of life, use of health system (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).
- Being tested
- Atrovent + Bricanyl or Atrovent + Ventoline, Placebo
- Keywords
- weaned tobacco, Has not submitted an exacerbation in the past 3 months
- 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.
Atrovent + Bricanyl or Atrovent + VentolineDrug
3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks
PlaceboDrug
1 capsule lactose during 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Atrovent + Bricanyl or Atrovent + Ventolin | Experimental | 3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form Atrovent 0,5mg/1ml Bricanyl 5mg/2ml Ventolin 5mg/2,5ml Receives: Drug: Atrovent + Bricanyl or Atrovent + Ventoline |
| Placebo | Placebo comparator | 1 capsule per day lactose (in addition to the standard optimized treatment) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score for quality of life, assessed by the questionnaire St Georges
Measured: Patients will be followed for the duration of their participation ie 48 weeks
Secondary outcomes (3)
Score for quality of life, assessed by the questionnaire VQ11
Measured: Patients will be followed for the duration of their participation ie 48 weeks
Dyspnea score according Medical Research Council
Measured: Patients will be followed for the duration of their participation ie 48 weeks
Prognostic Score Mortality assessed by the score BODE
Measured: Patients will be followed for the duration of their participation ie 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice DIOT, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103374
- Sponsor's protocol ID
- PHRN10-PD/Nebuadom
- Other IDs
- 2010-023743-14, 2010-R38, A101466-30
- Acronym
- Nebuadom
- Status last verified
- Apr 2016
- First submitted
- 12 Mar 2014
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State
- ClinicalTrials.gov ID
- NCT02103374
- Acronym / sponsor ID
- Nebuadom / PHRN10-PD/Nebuadom
- Keywords
- weaned tobacco, Has not submitted an exacerbation in the past 3 months
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Apr 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.
Design studies of nebulization in COPD does not respond adequately to the clinically relevant question: the intervention of administering nebulized bronchodilators at home it is likely to make a profit, compared to the standard optimized treatment as defined by the recommendations of the SPLF, patients with severe COPD (stage III, FEV between 30% and 50% of the theoretical value) and very severe (stage IV, less than 30% of the theoretical value FEV)? The concept of profit in this context is based on criteria of dyspnea, quality of life, use of health system (exacerbations, hospitalizations, prescription of antibiotics and steroids ...).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrovent + Bricanyl or Atrovent + Ventolin | Experimental | Drug: Atrovent + Bricanyl or Atrovent + Ventoline3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form Atrovent 0,5mg/1ml Bricanyl 5mg/2ml Ventolin 5mg/2,5ml |
| Placebo | Placebo comparator | Drug: Placebo1 capsule per day lactose (in addition to the standard optimized treatment) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult
- COPD Patients stage 3 et 4
- Has not submitted an exacerbation in the 3 months preceding the pre-inclusion visit
- Weaned from tobacco for at least 6 months
- vaccinated against pneumococcal
Key exclusion criteria (7 listed)
- Patient under nebulizer or has been treated with nebulized bronchodilators at home over the last 6 months
- Patient with an indication of oxygen is expected in the coming year
- Progressive malignant disease known
- Patient under non-invasive ventilation (NIV) for less than 6 months or NIV provided in the following year
- Patient known to be colonized by Pseudomonas aeruginosa, A. xylosoxidans, Burkholderia cepacia or Stenotrophomonas maltophilia
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 |
|---|---|---|
| Atrovent + Bricanyl or Atrovent + Ventoline3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks | Drug | Atrovent + Bricanyl or Atrovent + Ventolin |
| Placebo1 capsule lactose during 48 weeks | Drug | Placebo |
Primary outcome
Score for quality of life, assessed by the questionnaire St Georges
Time frame: Patients will be followed for the duration of their participation ie 48 weeks
3 secondary outcomes
Score for quality of life, assessed by the questionnaire VQ11
Time frame: Patients will be followed for the duration of their participation ie 48 weeks
Dyspnea score according Medical Research Council
Time frame: Patients will be followed for the duration of their participation ie 48 weeks
Prognostic Score Mortality assessed by the score BODE
Time frame: Patients will be followed for the duration of their participation ie 48 weeks
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 Apr 2016.
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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.
Patrice DIOT, MD-PhD principal investigator
University Hospital, Tours
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atrovent + Bricanyl or Atrovent + Ventoline in people with Severe Chronic Obstructive Pulmonary Disease, run by University Hospital, Tours at 13 sites in France.
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 7 inclusion and 7 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Score for quality of life, assessed by the questionnaire St Georges (time frame: Patients will be followed for the duration of their participation ie 48 weeks). 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 Apr 2016.