Allergic RhinitisPhase 2NCT01586468
PILOT STUDY OF THE EFFICACY AND SAFETY OF WF10 IN SUBJECTS SUFFERING FROM PERSISTENT ALLERGIC RHINITIS
A Phase 2 study testing WF10 and NaCl Solution in people with Allergic Rhinitis, run by Nuvo Research GmbH at 1 site in Germany.
Trial summary
Objectives To assess the efficacy and safety of WF10 infusions in the treatment of subjects with persistent allergic rhinitis. Study Design Randomized, double-blind, placebo-controlled, parallel-group, single-centre trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- WF10 and NaCl Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of persistent allergic rhinitis for at least 2 years prior to enrolment. Concurrent history of asthma is permitted.
- Positive allergen skin test to the relevant allergen(s), performed within the previous 2 years prior to enrolment.
- Mean score ≥6 for the baseline Total Nasal Symptom Score (TNSS)
- Screening laboratory values within normal range, except those related to the primary disease, including eosinophil count, and elevated glucose is allowed.
- Age between 18 and 70 years, inclusive.
- The subject must be able to read and understand German well enough to answer the questions in the TNSS and Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ), without any translation or explanation.
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- If female, the subject:
- Cannot become pregnant because she is surgically sterile (hysterectomy or tubal ligation), or is postmenopausal for at least 6 months prior to the screening visit.
- OR
- Is not pregnant, with a negative pregnancy test at screening (confirmed at the baseline visit), and uses an acceptable method of contraception with a low failure rate (PEARL Index) (i.e. less than 1% per year) when used consistently and correct (including oral contraceptives, hormone implant, intrauterine device, , male sexual partner(s) surgically sterile, abstinence).
- Except for persistent allergic rhinitis, the subject is in reasonably good health, as determined by the discretion of the study investigator (based on the physical examination and electrocardiogram [ECG] results).
- The subject has signed an informed consent form.
Who cannot join
- Non-allergic rhinitis, rhinitis medicamentosa, idiopathic rhinitis or sinusitis.
- History of nasal surgery in the 6 months prior to enrolment.
- An upper respiratory or sinus infection within the 2 weeks prior to enrolment.
- Presence of a severely deviated septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction.
- Use of intramuscular glucocorticosteroids in the 12 weeks prior to enrolment; use of oral, intravenous or medium or high daily dose inhaled glucocorticosteroids (as described in GINA guidelines - see App. III)) in the 4 weeks prior to enrolment; use of topical (nasal or ocular) glucocorticosteroids in the 2 weeks prior to enrolment. .
- Use of anti-IgE antibodies (e.g. omalizumab) in the 12 weeks prior to enrolment.
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- Use of anti-leukotrienes (e.g. montelukast) in the 4 weeks prior to enrolment.
- Unwillingness to discontinue prohibited medications and avoid their use during the study (see section 10.1.5 for a complete list of prohibited medications).
- Severe haematopoetic, cardiovascular, hepatic, renal, neurological or psychiatric disease.
- Glucose-6-phosphate dehydrogenase deficiency (activity < 60% = < WHO class 4)
- A female subject who is lactating.
- Planned travel outside of the study area during the first 22 days of the study.
- Any infirmity, disability or geographical location that would limit compliance with the protocol.
- A subject who has previously been randomized into this study, received at least one dose of study treatment and been withdrawn from this trial will not be allowed to re-enter.
- Use of another investigational drug within the 30 days prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT STUDY OF THE EFFICACY AND SAFETY OF WF10 IN SUBJECTS SUFFERING FROM PERSISTENT ALLERGIC RHINITIS
Objectives To assess the efficacy and safety of WF10 infusions in the treatment of subjects with persistent allergic rhinitis.
Study Design Randomized, double-blind, placebo-controlled, parallel-group, single-centre trial.
Read more
Subjects 50 subjects (25 per treatment group) with history of persistent allergic rhinitis for at least 2 years prior to enrolment and a positive allergen skin test. Subjects will be required to have a minimum mean score ≥6 for the baseline Total Nasal Symptom Score (TNSS) (mean score of morning and evening reflective TNSS assessments for the 3 days prior to randomization and treatment.
Treatments At the first treatment visit (T1), subjects that comply with the inclusion and exclusion criteria will be randomized into one of two treatment groups: WF10, or placebo.
Each individual treatment dose of study drug solution is 0.5 mL/kg body weight, diluted into 500 mL saline solution. Treatment will be administered once daily for 5 consecutive days (Visits T1-T5) via intravenous infusion.
- Conditions
- Allergic Rhinitis
- Being tested
- WF10, NaCl Solution
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WF10Drug
0.5 mg/kg B.W.
NaCl SolutionDrug
NaCl Solution
| Study group | Role | What they receive |
|---|---|---|
| NaCl Solution | Placebo comparator | Not described Receives: Drug: NaCl Solution |
| WF10 0.5 ml/kg BW | Experimental | Not described Receives: Drug: WF10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNSS
Measured: 9 weeks
Secondary outcomes (1)
MiniRQLQ score, POHA score, and rhinometric and spirometric parameters
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvo Research GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Gessner, M.D., Principal investigator, POIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586468
- Sponsor's protocol ID
- WF10-07-002
- Status last verified
- Feb 2010
- First submitted
- 25 Apr 2012
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PILOT STUDY OF THE EFFICACY AND SAFETY OF WF10 IN SUBJECTS SUFFERING FROM PERSISTENT ALLERGIC RHINITIS
- ClinicalTrials.gov ID
- NCT01586468
- Acronym / sponsor ID
- WF10-07-002
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nuvo Research GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Apr 2012 (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.
Objectives To assess the efficacy and safety of WF10 infusions in the treatment of subjects with persistent allergic rhinitis.
Study Design Randomized, double-blind, placebo-controlled, parallel-group, single-centre trial.
Subjects 50 subjects (25 per treatment group) with history of persistent allergic rhinitis for at least 2 years prior to enrolment and a positive allergen skin test. Subjects will be required to have a minimum mean score ≥6 for the baseline Total Nasal Symptom Score (TNSS) (mean score of morning and evening reflective TNSS assessments for the 3 days prior to randomization and treatment.
Treatments At the first treatment visit (T1), subjects that comply with the inclusion and exclusion criteria will be randomized into one of two treatment groups: WF10, or placebo.
Each individual treatment dose of study drug solution is 0.5 mL/kg body weight, diluted into 500 mL saline solution. Treatment will be administered once daily for 5 consecutive days (Visits T1-T5) via intravenous infusion.
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 |
|---|---|---|
| NaCl Solution | Placebo comparator | Drug: NaCl Solution |
| WF10 0.5 ml/kg BW | Experimental | Drug: WF10 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- History of persistent allergic rhinitis for at least 2 years prior to enrolment. Concurrent history of asthma is permitted.
- Positive allergen skin test to the relevant allergen(s), performed within the previous 2 years prior to enrolment.
- Mean score ≥6 for the baseline Total Nasal Symptom Score (TNSS)
- Screening laboratory values within normal range, except those related to the primary disease, including eosinophil count, and elevated glucose is allowed.
- Age between 18 and 70 years, inclusive.
Key exclusion criteria (15 listed)
- Non-allergic rhinitis, rhinitis medicamentosa, idiopathic rhinitis or sinusitis.
- History of nasal surgery in the 6 months prior to enrolment.
- An upper respiratory or sinus infection within the 2 weeks prior to enrolment.
- Presence of a severely deviated septum, septal perforation, structural nasal defect or large nasal polyps causing obstruction.
- Use of intramuscular glucocorticosteroids in the 12 weeks prior to enrolment; use of oral, intravenous or medium or high daily dose inhaled glucocorticosteroids (as described in GINA guidelines - see App. III)) in the 4 weeks prior to enrolment; use of topical (nasal or ocular) glucocorticosteroids in the 2 weeks prior to enrolment. .
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 |
|---|---|---|
| WF100.5 mg/kg B.W. | Drug | WF10 0.5 ml/kg BW |
| NaCl SolutionNaCl Solution | Drug | NaCl Solution |
Primary outcome
TNSS
Time frame: 9 weeks
1 secondary outcome
MiniRQLQ score, POHA score, and rhinometric and spirometric parameters
Time frame: 9 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 26 Apr 2012.
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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.
Christian Gessner, M.D. principal investigator
POIS
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 WF10 and NaCl Solution in people with Allergic Rhinitis, run by Nuvo Research GmbH 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 12 inclusion and 15 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 26 Apr 2012. 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?
TNSS (time frame: 9 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 26 Apr 2012.