Cystic FibrosisNCT01086839
Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis
A study testing sodium chloride 6% and sodium chloride 0,9% in people with Cystic Fibrosis and Rhinosinusitis, run by University of Jena at 11 sites in Germany.
Trial summary
Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation with bacterial superinfection. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cystic Fibrosis, Rhinosinusitis
- What is being tested?
- sodium chloride 6% and sodium chloride 0,9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 11 sitesGermany
- Study dates
- Mar 2010to Jun 2013
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has a confirmed diagnosis of cystic fibrosis based on: 2 positive sweat chloride tests and/or genetic characterization
- Subject is 8 years of age or older
- informed consent of the patient or legal representative
- Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (failure rate <1% e.g. implants, combined oral contraceptives, injectables, some intrauterine devices, sexual abstinence or vasectomised partner)
Who cannot join
- Subject has no chronic rhinosinusitis (European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS-criteria)
- Subject has a critical condition defined as: forced expiratory volume at one second < 30% and / or arterial oxygen saturation < 93% without O2-substitution; need of O2-substitution
- Subject had an ENT surgery within 6 months prior to study
- Subject participates in another clinical trial within 30 days prior to study entry
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
J.W. Goethe Universität - Abtl. Pneumologie
Frankfurt am Main, Hesse, 60590
Zentrum für Kinder- und Jugendmedizin
Greifswald, Brandenburg, 17487
CF-Zentrum
Hamburg
Zentrum für Kinder- und Jugendmedizin
Heidelberg, Baden Würtemberg, 69120
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thuringia
Universitätsklinikum
Leipzig, Saxony, 04103
Medizinische Klinik Innenstadt
München, Bavaria, 80336
Klinik für Kinder- und Jugendmedizin
Münster, North Rhine-Westphalia, 48149
Universitäts-Kinderklinik
Tübingen, Baden-Wurttemberg
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
About this study
Official title: Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial
Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation with bacterial superinfection.
In CF rhinosinusitis can restrict quality of life, give cause to repeated ear, nose, and throat (ENT) surgery and accelerate disease progression by bacterial acquisition into the airways.
The multicenter, randomized, double-blind, placebo-controlled, prospective clinical trial aims at the evaluation of a sino-nasal inhalation of sodium chloride 6% compared to isotonic saline with respect to ENT-related quality of life which is influenced by mucus retention and the resulting inflammation.
- Conditions
- Cystic Fibrosis, Rhinosinusitis
- Being tested
- sodium chloride 6%, sodium chloride 0,9%
- Keywords
- Cystic Fibrosis, chronic rhinosinusitis
- Medical subject headings
- Cystic Fibrosis, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium chloride 6%Drug
- one ampoule sodium chloride 6% per day
- inhalation use
- for 28 days
sodium chloride 0,9%Drug
- one ampoule sodium chloride 0,9% per day
- inhalation use
- for 28 days
| Study group | Role | What they receive |
|---|---|---|
| sodium chloride 6% | Experimental | Cross-Over! "experimental" (days 1 - 28), then Wash-Out (28 days),then "placebo comparator" (days 57 - 85). Receives: Drug: sodium chloride 6% |
| sodium chloride 0,9% | Placebo comparator | Cross-Over! "placebo comparator" (days 1 - 28), then Wash-Out (28 days),then "experimental" (days 57 - 85). Receives: Drug: sodium chloride 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Sino-nasal-outcome test SNOT-20 adapt CF
Measured: days 1, 29, 57 and 85
Secondary outcomes (1)
Changes in the nasal lavage fluid and in the serological markers of inflammation
Measured: days 1, 29, 57 and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Jochen G. Mainz, University of Jena
- Investigators
- Jochen Mainz, M.D., Study chair, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086839
- Sponsor's protocol ID
- NaCl 6.0%-nasal-CF
- Status last verified
- Nov 2014
- First submitted
- 12 Mar 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mainz JG, Koitschev A. Management of chronic rhinosinusitis in CF. J Cyst Fibros. 2009 Jun;8 Suppl 1:S10-4. doi: 10.1016/S1569-1993(09)60005-9.
PubMed 19460681Mainz JG, Naehrlich L, Schien M, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.
PubMed 19282318Mainz JG, Schien C, Schiller I, Schadlich K, Koitschev A, Koitschev C, Riethmuller J, Graepler-Mainka U, Wiedemann B, Beck JF. Sinonasal inhalation of dornase alfa administered by vibrating aerosol to cystic fibrosis patients: a double-blind placebo-controlled cross-over trial. J Cyst Fibros. 2014 Jul;13(4):461-70. doi: 10.1016/j.jcf.2014.02.005. Epub 2014 Mar 1.
PubMed 24594542Mainz JG, Schadlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, Koitschev C, Keller PM, Riethmuller J, Wiedemann B, Beck JF. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study. Drug Des Devel Ther. 2014 Feb 10;8:209-17. doi: 10.2147/DDDT.S54064. eCollection 2014.
PubMed 24596456Mainz JG, Schumacher U, Schadlich K, Hentschel J, Koitschev C, Koitschev A, Riethmuller J, Prenzel F, Sommerburg O, Wiedemann B, Staab D, Gleiber W, Fischer R, Beck JF, Arnold C; Cooperators. Sino nasal inhalation of isotonic versus hypertonic saline (6.0%) in CF patients with chronic rhinosinusitis - Results of a multicenter, prospective, randomized, double-blind, controlled trial. J Cyst Fibros. 2016 Nov;15(6):e57-e66. doi: 10.1016/j.jcf.2016.05.003. Epub 2016 Jun 5.
PubMed 27267518
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01086839
- Acronym / sponsor ID
- NaCl 6.0%-nasal-CF
- Conditions
- Cystic Fibrosis, Rhinosinusitis
- Keywords
- Cystic Fibrosis, chronic rhinosinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Mar 2010 (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.
Rhinosinusitis disorders are almost regularly associated to Cystic Fibrosis (CF). The basic defect in CF is a dysfunction of chloride channels in exocrine glands which equally concerns upper airway mucosa. It leads to retention of secretions and consecutive chronic inflammation with bacterial superinfection.
In CF rhinosinusitis can restrict quality of life, give cause to repeated ear, nose, and throat (ENT) surgery and accelerate disease progression by bacterial acquisition into the airways.
The multicenter, randomized, double-blind, placebo-controlled, prospective clinical trial aims at the evaluation of a sino-nasal inhalation of sodium chloride 6% compared to isotonic saline with respect to ENT-related quality of life which is influenced by mucus retention and the resulting inflammation.
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 |
|---|---|---|
| sodium chloride 6% | Experimental | Drug: sodium chloride 6%Cross-Over! "experimental" (days 1 - 28), then Wash-Out (28 days),then "placebo comparator" (days 57 - 85). |
| sodium chloride 0,9% | Placebo comparator | Drug: sodium chloride 0,9%Cross-Over! "placebo comparator" (days 1 - 28), then Wash-Out (28 days),then "experimental" (days 57 - 85). |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has a confirmed diagnosis of cystic fibrosis based on: 2 positive sweat chloride tests and/or genetic characterization
- Subject is 8 years of age or older
- informed consent of the patient or legal representative
- Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (failure rate <1% e.g. implants, combined oral contraceptives, injectables, some intrauterine devices, sexual abstinence or vasectomised partner)
Key exclusion criteria (4 listed)
- Subject has no chronic rhinosinusitis (European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS-criteria)
- Subject has a critical condition defined as: forced expiratory volume at one second < 30% and / or arterial oxygen saturation < 93% without O2-substitution; need of O2-substitution
- Subject had an ENT surgery within 6 months prior to study
- Subject participates in another clinical trial within 30 days prior to study entry
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 |
|---|---|---|
| sodium chloride 6%* one ampoule sodium chloride 6% per day * inhalation use * for 28 days | Drug | sodium chloride 6% |
| sodium chloride 0,9%* one ampoule sodium chloride 0,9% per day * inhalation use * for 28 days | Drug | sodium chloride 0,9% |
Primary outcome
Changes in the Sino-nasal-outcome test SNOT-20 adapt CF
Time frame: days 1, 29, 57 and 85
1 secondary outcome
Changes in the nasal lavage fluid and in the serological markers of inflammation
Time frame: days 1, 29, 57 and 85
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 2 Dec 2014.
- Background: PubMed 19460681Mainz JG, Koitschev A. Management of chronic rhinosinusitis in CF. J Cyst Fibros. 2009 Jun;8 Suppl 1:S10-4. doi: 10.1016/S1569-1993(09)60005-9.
- Background: PubMed 19282318Mainz JG, Naehrlich L, Schien M, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.
- Background: PubMed 24594542Mainz JG, Schien C, Schiller I, Schadlich K, Koitschev A, Koitschev C, Riethmuller J, Graepler-Mainka U, Wiedemann B, Beck JF. Sinonasal inhalation of dornase alfa administered by vibrating aerosol to cystic fibrosis patients: a double-blind placebo-controlled cross-over trial. J Cyst Fibros. 2014 Jul;13(4):461-70. doi: 10.1016/j.jcf.2014.02.005. Epub 2014 Mar 1.
- Background: PubMed 24596456Mainz JG, Schadlich K, Schien C, Michl R, Schelhorn-Neise P, Koitschev A, Koitschev C, Keller PM, Riethmuller J, Wiedemann B, Beck JF. Sinonasal inhalation of tobramycin vibrating aerosol in cystic fibrosis patients with upper airway Pseudomonas aeruginosa colonization: results of a randomized, double-blind, placebo-controlled pilot study. Drug Des Devel Ther. 2014 Feb 10;8:209-17. doi: 10.2147/DDDT.S54064. eCollection 2014.
- Derived from this study: PubMed 27267518Mainz JG, Schumacher U, Schadlich K, Hentschel J, Koitschev C, Koitschev A, Riethmuller J, Prenzel F, Sommerburg O, Wiedemann B, Staab D, Gleiber W, Fischer R, Beck JF, Arnold C; Cooperators. Sino nasal inhalation of isotonic versus hypertonic saline (6.0%) in CF patients with chronic rhinosinusitis - Results of a multicenter, prospective, randomized, double-blind, controlled trial. J Cyst Fibros. 2016 Nov;15(6):e57-e66. doi: 10.1016/j.jcf.2016.05.003. Epub 2016 Jun 5.
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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.
Jochen Mainz, M.D. study chair
University of Jena
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sodium chloride 6% and sodium chloride 0,9% in people with Cystic Fibrosis and Rhinosinusitis, run by University of Jena at 11 sites 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 4 inclusion and 4 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
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?
Changes in the Sino-nasal-outcome test SNOT-20 adapt CF (time frame: days 1, 29, 57 and 85). 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 NCT01086839, which also lists 5 linked publications.
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 2 Dec 2014.