Seasonal Allergic RhinitisPhase 2NCT01230619
Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis
A Phase 2 study testing RV568 in people with Seasonal Allergic Rhinitis, run by Respivert Ltd at 1 site in Austria.
Trial summary
RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 ameliorates the nasal symptoms to low doses of grass pollen in healthy subjects with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- RV568
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2010to Dec 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is healthy
- History of seasonal allergic rhinitis
- Male aged between 18 and 55 years
- Body weight >/= 50 kg with BMI in range 19 - 29 kg/m2 (inclusive)
- Exhibits a moderate response to 4 hour exposure to grass pollen in the challenge chamber with a total nasal symptom score (TNSS) of >/= 6
- Positive skin prick test (wheal >/= 4 mm) for grass pollen
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- Positive total IgE result (RAST class >/= 2) for grass pollen
- Current non-smoker who has not used tobacco in the past 6 months with a pack history of </= 10 pack years
- Baseline FEV1 >/= 80% and FEV1/FVC >/= 70% of predicted values
- No conditions or factors that may preclude subjects ability to remain in the challenge chamber for a period of 6 hours
- capable of giving informed consent and is compliant with protocol requirements
- available to complete all study measurements
Who cannot join
- structural nasal abnormalities or nasal polyps, history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection
- history of drug allergy
- participation in another clinical trial or has participated in a study using an NCE within the previous 3 months, or any clinical study within 1 month
- taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, macrolides, anti-fungal agents and herbal remedies. Paracetamol (</= 2g / day) and occasional short acting beta agonists are permitted
- use of oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit
- past or present disease, which as judged by the investigator, may affect the outcome of the study
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- regular consumption of > 21 units alcohol per week
- infected with Hepatitis B, Hepatitis C, or HIV virus
- current or chronic history of liver disease, or known hepatic or biliary abnormalities
- positive test for drugs of abuse or alcohol at screening
- previously known allergy to any of the active or inactive ingredients in the study medication
- mentally or legally incapacitated
- any other reason that the investigator considers makes the subject unsuitable to participate
Trial locations and contacts
1 site in 1 country.
Austria1 site
Institute for Allergy Research, Vienna Challenge Chamber
Vienna, 1150
About this study
Official title: A Two Day, Randomised, Single Blind, Parallel Group Trial of Repeat Doses of Intranasal RV568 in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR)
RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 ameliorates the nasal symptoms to low doses of grass pollen in healthy subjects with seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- RV568, Placebo
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV568Drug
RV568 400 ug administered as nasal drops twice daily on Day 1, RV568 800 ug administered as nasal drops once daily on Day 2
PlaceboDrug
Placebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2
| Study group | Role | What they receive |
|---|---|---|
| RV568 treatment group | Experimental | Not described Receives: Drug: RV568 |
| Placebo treatment group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total nasal symptom score (TNSS)
Nasal congestion, rhinorrhoea, nasal itching and sneezing will be scored on a categorical scale from 0 to 3. Individual scores will be summed to produce the TNSS
Measured: 2 day treatment period
Secondary outcomes (4)
Eye symptom score
Watery eyes, itchy eyes, red eyes will be scored on a categorical scale of 0 to 3
Measured: 2 day treatment period
Global symptom score
Sum of symptom scores; TNSS, Eye symptom score, Other symptom score,(comprising congestion, rhinorrhoea, nasal itching, sneezing, watery eyes, itchy eyes, red eyes, cough, itchy throat and itchy ears) will be scored categorically from 0 to 3
Measured: 2 day treatment period
Nasal airflow resistance
Measured: 2 day treatment period
Safety parameters
Spirometry, 12-lead ECG, laboratory assessments and adverse event assessment
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respivert Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Prof Dr Friedrich Horak, MD, Principal investigator, Institute for Allergy Research - Vienna Challenge Chamber
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230619
- Sponsor's protocol ID
- RVH002
- Other IDs
- 2010-022113-25
- Status last verified
- Dec 2010
- First submitted
- 27 Oct 2010
- Last updated
- 6 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Day, Randomised, Single Blind, Parallel Group Trial of Repeat Doses of Intranasal RV568 in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR)
- ClinicalTrials.gov ID
- NCT01230619
- Acronym / sponsor ID
- RVH002
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Respivert LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Oct 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.
RV568 is being developed for the treatment of diseases such as asthma, COPD and allergic rhinitis (e.g. hayfever). The main aim of this study is to investigate whether RV568 ameliorates the nasal symptoms to low doses of grass pollen in healthy subjects with seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RV568 treatment group | Experimental | Drug: RV568 |
| Placebo treatment group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subject is healthy
- History of seasonal allergic rhinitis
- Male aged between 18 and 55 years
- Body weight >/= 50 kg with BMI in range 19 - 29 kg/m2 (inclusive)
- Exhibits a moderate response to 4 hour exposure to grass pollen in the challenge chamber with a total nasal symptom score (TNSS) of >/= 6
Key exclusion criteria (13 listed)
- structural nasal abnormalities or nasal polyps, history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection
- history of drug allergy
- participation in another clinical trial or has participated in a study using an NCE within the previous 3 months, or any clinical study within 1 month
- taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, macrolides, anti-fungal agents and herbal remedies. Paracetamol (</= 2g / day) and occasional short acting beta agonists are permitted
- use of oral, injectable or dermal steroids within 5 weeks or intranasal and/or inhaled steroids within 1 week of the screening visit
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 |
|---|---|---|
| RV568RV568 400 ug administered as nasal drops twice daily on Day 1, RV568 800 ug administered as nasal drops once daily on Day 2 | Drug | RV568 treatment group |
| PlaceboPlacebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2 | Drug | Placebo treatment group |
Primary outcome
Total nasal symptom score (TNSS)
Time frame: 2 day treatment period
Nasal congestion, rhinorrhoea, nasal itching and sneezing will be scored on a categorical scale from 0 to 3. Individual scores will be summed to produce the TNSS
4 secondary outcomes
Eye symptom score
Time frame: 2 day treatment period
Global symptom score
Time frame: 2 day treatment period
Nasal airflow resistance
Time frame: 2 day treatment period
Safety parameters
Time frame: 3 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 6 Dec 2010.
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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.
Prof Dr Friedrich Horak, MD principal investigator
Institute for Allergy Research - Vienna Challenge Chamber
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 RV568 in people with Seasonal Allergic Rhinitis, run by Respivert Ltd at 1 site in Austria.
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 13 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 6 Dec 2010. 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 Austria. 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?
Total nasal symptom score (TNSS) (time frame: 2 day treatment 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 6 Dec 2010.