Cystic FibrosisPhase 2NCT00774072
Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization
A Phase 2 study testing Tobramycin (Gernebcin®) in people with Cystic Fibrosis and Pseudomonas Aeruginosa, run by University of Jena at 2 sites in Germany.
Trial summary
The purpose of this study is to determine whether the nasal inhalation of Gernebcin® is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cystic Fibrosis, Pseudomonas Aeruginosa
- What is being tested?
- Tobramycin (Gernebcin®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2008to Nov 2010
- 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 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
- detection of P. aeruginosa in nasal lavage (culture) with chronic P.a. colonization of the lung (from day -28)
- informed consent of the patients or parents
- subject is older than 7 years
- subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol
- women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol
Who cannot join
- subject has a critical condition defined as: FEV1 < 30% and / or SaO2 < 93% without O2-substitution; need of O2-substitution
- subject had an ENT surgery within 3 months prior to study
- subject shows signs of nasal bleeding
- subject has an ear drum perforation
- subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aerug.
- subject is unlikely to comply with the procedures scheduled in the protocol
Show all 14Show fewer
- subject has a known allergic reaction to the medication
- subject is pregnant or breastfeeding
- subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.
- systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the inclusion and during the study
- if serum level of tobramycin is above 2 mg/l one hour after inhalation, subject has to withdraw the participation in the study.
- progressed renal insufficiency
- severe damage of the N. acusticus
- dizziness (potential damage of. N. vestibularis)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Mukoviszidosezentrum der Friedrich-Schiller-Universität
Jena, Thuringia, 07745
Universitäts-Kinderklinik
Tübingen, Baden-Würtemberg, 72076
About this study
Official title: Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways
The purpose of this study is to determine whether the nasal inhalation of Gernebcin® is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa
- Being tested
- Tobramycin (Gernebcin®)
- Keywords
- subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobramycin (Gernebcin®)Drug
1 ml / day in each nostril
| Study group | Role | What they receive |
|---|---|---|
| Tobramycin 80 mg | Active comparator | applied once daily via Pari Sinus nebulizer Receives: Drug: Tobramycin (Gernebcin®) |
| isotonic saline | Placebo comparator | applied once daily via Pari Sinus nebulizer Receives: Drug: Tobramycin (Gernebcin®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid
Measured: day -1, 1, 29, 30, 59, 60
Secondary outcomes (2)
Measure of serum levels of tobramycin
Measured: day 1, 30 and 60
Tolerability
Measured: day 1, 30 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 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, Children's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774072
- Sponsor's protocol ID
- tobra nasal CF pilot
- Status last verified
- Dec 2014
- First submitted
- 16 Oct 2008
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mainz JG, Arnold C. Authors' reply. Drug Des Devel Ther. 2014;8:1136-7. No abstract available.
PubMed 25199217Mainz JG, Michl R, Pfister W, Beck JF. Cystic fibrosis upper airways primary colonization with Pseudomonas aeruginosa: eradicated by sinonasal antibiotic inhalation. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1089-90. doi: 10.1164/ajrccm.184.9.1089. No abstract available.
PubMed 22045752Mainz 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 24596456
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways
- ClinicalTrials.gov ID
- NCT00774072
- Acronym / sponsor ID
- tobra nasal CF pilot
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa
- Keywords
- subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 17 Oct 2008 (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.
The purpose of this study is to determine whether the nasal inhalation of Gernebcin® is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobramycin 80 mg | Active comparator | Drug: Tobramycin (Gernebcin®)applied once daily via Pari Sinus nebulizer |
| isotonic saline | Placebo comparator | Drug: Tobramycin (Gernebcin®)applied once daily via Pari Sinus nebulizer |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- subject has a confirmed diagnosis of cystic fibrosis
- detection of P. aeruginosa in nasal lavage (culture) with chronic P.a. colonization of the lung (from day -28)
- informed consent of the patients or parents
- subject is older than 7 years
- subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol
Key exclusion criteria (14 listed)
- subject has a critical condition defined as: FEV1 < 30% and / or SaO2 < 93% without O2-substitution; need of O2-substitution
- subject had an ENT surgery within 3 months prior to study
- subject shows signs of nasal bleeding
- subject has an ear drum perforation
- subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aerug.
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 |
|---|---|---|
| Tobramycin (Gernebcin®)1 ml / day in each nostril | Drug | Tobramycin 80 mg, isotonic saline |
Primary outcome
Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid
Time frame: day -1, 1, 29, 30, 59, 60
2 secondary outcomes
Measure of serum levels of tobramycin
Time frame: day 1, 30 and 60
Tolerability
Time frame: day 1, 30 and 60
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 Dec 2014.
- Background: PubMed 25199217Mainz JG, Arnold C. Authors' reply. Drug Des Devel Ther. 2014;8:1136-7. No abstract available.
- Background: PubMed 22045752Mainz JG, Michl R, Pfister W, Beck JF. Cystic fibrosis upper airways primary colonization with Pseudomonas aeruginosa: eradicated by sinonasal antibiotic inhalation. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1089-90. doi: 10.1164/ajrccm.184.9.1089. No abstract available.
- Results publication: 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.
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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, Children's hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tobramycin (Gernebcin®) in people with Cystic Fibrosis and Pseudomonas Aeruginosa, run by University of Jena at 2 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 6 inclusion and 14 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 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 2 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.
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?
Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid (time frame: day -1, 1, 29, 30, 59, 60). 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 NCT00774072, which also lists 3 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 4 Dec 2014.