Chronic RhinosinusitisRespireNCT03145051
Efficacy of Nasal Irrigation With Respimer® Netiflow® vs Saline Among Patients With Cystic Fibrosis and Chronic Rhinosinusitis
A study testing Saline solution and Respimer Netiflow in people with Chronic Rhinosinusitis and Cystic Fibrosis, run by Laboratoire de la Mer at 1 site in France.
Trial summary
Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and older with cystic fibrosis and suffering from… Read more about this study
- Who is it for?
- Ages 11 to 65 years
- Conditions the study is for
- Chronic Rhinosinusitis, Cystic Fibrosis
- What is being tested?
- Saline solution and Respimer Netiflow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- 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 11 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Patient with Cystic Fibrosis with or without lung transplant;
- Patients with allergic chronic rhino sinusitis or no allergic diagnosed by the clinical investigator on the basis of the following signs in variable combination: nasal congestion, headache, sneezing, itchy nose and eyes, runny nose, nosebleeds and nasal crusts, redness and eye discharge present more than 3 months per year.
- Patient treated on an outpatient basis;
- Patient agreeing not to take sea baths for the duration of the study;
- Patient agreeing to respect the procedures for conducting the study, in particular the washout period and follow-up visits;
- Patient capable of understanding and self-completing the questionnaires;
- For juvenile patients, the holder (s) of parental authority have accepted the participation of the young person (by signing the informed consent after having taken note of the information note)
- Member or beneficiary of a social security program
Who cannot join
- Patients with significant obstruction of the nasal passages due to:
- a mucocele,
- polyposis causing nasal obstruction> 90% or
- severe malformation of the septum causing a nasal obstruction> 90% in whom surgical treatment is recommended;
- Patients with signs of severity that may require hospitalization, such as: severe impairment of general health, dyspnoea with cyanosis, high fever (> 40 ° C).
- Patients requiring corticosteroid therapy during the study, with the exception of patients who received pulmonary transplant and were treated with oral corticosteroids at no more than 0.2 mg / kg / day.
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- Patients with known systemic immunodeficiency status with the exception of patients receiving pulmonary transplantation and immunosuppressed.
- Patient pregnant (urine test) or without effective contraception (birth control pill, contraceptive patch, contraceptive implant, vaginal ring, intrauterine device or intrauterine device, male condom).
- Nursing patient.
- Patient with a contraindication to nasal irrigations as defined in the product leaflet.
Trial locations and contacts
1 site in 1 country.
France1 site
ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil
Créteil, 94010
About this study
Official title: Prospective, Randomized, Cross-over, Multicenter, Trial Comparing the Efficacy and Tolerability of Nasal Irrigation With Respimer® Netiflow® Mineral Salts Solution Versus Saline Among Patients With Cystic Fibrosis and Suffering From Chronic Rhinosinusitis
Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and older with cystic fibrosis and suffering from chronic rhinosinusitis.
- Conditions
- Chronic Rhinosinusitis, Cystic Fibrosis
- Being tested
- Saline solution, Respimer Netiflow
- Keywords
- saline solution, minerals, cystic fibrosis, chronic rhinosinusitis, nasal irrigation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline solutionOther
Also called nasal irrigation care
a nasal irrigation care
Respimer NetiflowOther
Also called nasal irrigation care
a nasal irrigation care
| Study group | Role | What they receive |
|---|---|---|
| Respimer Netiflow mineral salts solution | Experimental | Nasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device Receives: Other: Respimer Netiflow |
| Saline solution | Active comparator | Nasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution compared to saline solution between inclusion and the end of treatment period.
Quality of life to be assessed over an 8 weeks period of nasal wash using SNOT-20 questionnaire
Measured: over an 8 weeks period
Secondary outcomes (6)
Clinical status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.
Clinical status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Symptomatic Score (LKSS)
Measured: over an 8 weeks period
Endoscopic status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.
Endoscopic status to be assessed after 4 and 8 weeks of nasal wash using Lund-Kennedy Endoscopic Score (LKES)
Measured: over an 8 weeks period
Mucociliary transport change among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.
Mucociliary transport to be assessed after 4 and 8 weeks of nasal wash using saccharine test
Measured: over an 8 weeks period
Evolution of nasal bacterial pathogens among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.
Evolution of nasal bacterial pathogens to be assessed by bacteriologic swab within ethmoid nasal cavities after 4 and 8 weeks of nasal wash
Measured: over an 8 weeks period
Patient treatment acceptance of nasal irrigation with Respimer® Netiflow® medical device
Patient treatment acceptance to be assessed by Morisky score after 4 and 8 weeks of nasal wash
Measured: over an 8 weeks period
Occurrence of adverse events : taste impairment, epistaxis, nasal irritations, nasal burning
Adverse events to be assessed based on vigilance tracking during the whole study period
Measured: over an 8 weeks period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startJan 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire de la Mer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145051
- Sponsor's protocol ID
- Laboratoiredelamer
- Acronym
- Respire
- Status last verified
- Aug 2017
- First submitted
- 15 Nov 2016
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Cross-over, Multicenter, Trial Comparing the Efficacy and Tolerability of Nasal Irrigation With Respimer® Netiflow® Mineral Salts Solution Versus Saline Among Patients With Cystic Fibrosis and Suffering From Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT03145051
- Acronym / sponsor ID
- Respire / Laboratoiredelamer
- Conditions
- Chronic Rhinosinusitis, Cystic Fibrosis
- Keywords
- saline solution, minerals, cystic fibrosis, chronic rhinosinusitis, nasal irrigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Laboratoire de la MerIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 May 2017 (actual)
- 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.
Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and older with cystic fibrosis and suffering from chronic rhinosinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respimer Netiflow mineral salts solution | Experimental | Other: Respimer NetiflowNasal irrigation with Respimer Netiflow mineral salts solution, 4 times/day during 8 weeks using Respimer Netiflow class I medical device |
| Saline solution | Active comparator | Other: Saline solutionNasal irrigation with saline solution , 4 times/day during 8 weeks using Respimer Netiflow class I medical device |
Who may qualify
- Ages
- 11 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- • Patient with Cystic Fibrosis with or without lung transplant;
Key exclusion criteria (10 listed)
- Patients with significant obstruction of the nasal passages due to:
- a mucocele,
- polyposis causing nasal obstruction> 90% or
- severe malformation of the septum causing a nasal obstruction> 90% in whom surgical treatment is recommended;
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 |
|---|---|---|
| Saline solutionAlso: nasal irrigation carea nasal irrigation care | Other | Saline solution |
| Respimer NetiflowAlso: nasal irrigation carea nasal irrigation care | Other | Respimer Netiflow mineral salts solution |
Primary outcome
Change in quality of life among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution compared to saline solution between inclusion and the end of treatment period.
Time frame: over an 8 weeks period
Quality of life to be assessed over an 8 weeks period of nasal wash using SNOT-20 questionnaire
6 secondary outcomes
Clinical status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.
Time frame: over an 8 weeks period
Endoscopic status evolution among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.
Time frame: over an 8 weeks period
Mucociliary transport change among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.
Time frame: over an 8 weeks period
Evolution of nasal bacterial pathogens among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution to saline solution between inclusion and the end of treatment period.
Time frame: over an 8 weeks period
Patient treatment acceptance of nasal irrigation with Respimer® Netiflow® medical device
Time frame: over an 8 weeks period
Occurrence of adverse events : taste impairment, epistaxis, nasal irritations, nasal burning
Time frame: over an 8 weeks period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Individual participant dataSharing planned: No
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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 study testing Saline solution and Respimer Netiflow in people with Chronic Rhinosinusitis and Cystic Fibrosis, run by Laboratoire de la Mer at 1 site 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 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: status not confirmed, as of the sponsor's last update on 1 Sep 2017. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Change in quality of life among subjects undergoing nasal irrigation with Respimer® Netiflow® mineral salts solution compared to saline solution between inclusion and the end of treatment period. (time frame: over an 8 weeks 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 1 Sep 2017.