Allergic RhinitisPhase 4SMANNCT00825656
Comparative Study of Sinol and Sinol-M in Patients With Congestion Due to Allergic Rhinitis
A Phase 4 study testing Sinol or Sinol-M nasal spray in people with Allergic Rhinitis, run by Strategic Biosciences at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate the equivalence of two homeopathic capsaicin containing nasal sprays (Sinol-M™ and Sinol) in patients with nasal congestion due to allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Sinol or Sinol-M nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2009
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing to participate as indicated by providing written informed consent
- 12 years of age or older, of any gender and any race
- Have had a positive skin prick and/or intradermal test for a currently prevalent allergen within the past 5 years
- A history of allergic rhinitis, for at least 2 years
- Have undergone washout of all medications that could have an influence on the study
- Willing and able to make required study visits
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- Able to follow instructions and record diary symptoms.
- Free of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination
- Have a TNSS between 4 and 12 averaged over the 7 days immediately prior to V2
- Have an average individual score for nasal congestion greater than or equal to 2 over the 7 days immediately prior to V2.
Who cannot join
- any concurrent disease that could interfere with the investigation or evaluation of the study medications such as: rhinitis medicamentosa or large obstructive nasal polyps
- any other anatomic nasal deformity that could interfere with their participation in the study
- asthma, with the exception of mild intermittent asthma
- congestion that, in the opinion of the study investigator, could interfere with successful nasal drug administration/absorption (in either nostril)
- use of systemic corticosteroids (oral, parenteral, intravenous, rectal) or inhaled or ocular corticosteroids within the last 30 days
- be undergoing allergy immunotherapy, unless on a stable dosing regimen throughout the course of the study
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- Be using dermal potent or super-potent topical corticosteroids
- any systemic disorder that could interfere with the evaluation of the study medication
- hypersensitivity to the study drugs or any component thereof
- history of drug or alcohol abuse that would interfere with participation in the study
- history of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses that could be expected to interfere with the study
- upper or lower respiratory infection within 14 days of Vist 2
- acute sinusitis within 30 days of Visit 2
- any history or evidence of nasolacrimal drainage system malfunction
- Be planning to travel to an area significantly antigenically different for a substantial portion (more than 48 hours) of any given study week.
- participation in any other investigational study within 30 days before entry into this study or concomitantly with this study
- chronic or intermittent use of any prescription or over-the-counter (OTC) nasal spray during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Allergy and Asthma
Wheaton, Maryland, 20902
About this study
Official title: SINOL + MucoAd™ (SMAN) Evaluation Trial: A Double-Blind, Cross-Over Comparison of SINOL and SMAN in Subjects With Congestion Due to Allergic Rhinitis
The purpose of this study is to demonstrate the equivalence of two homeopathic capsaicin containing nasal sprays (Sinol-M™ and Sinol) in patients with nasal congestion due to allergic rhinitis.
Read the detailed description
Sinol is an FDA registered, capsaicin-based, over-the-counter homeopathic nasal spray used for the relief of allergy and sinus conditions. It is an all-natural product that the patient uses on an as-needed basis for up to 12 times daily.
Sinol has been available in the US since 2004. In 2009 a second generation product, Sinol-M will be launched. Sinol-M is identical to the original formula but also contains MucoAd MucoAd™ is a patented non-toxic, non-irritating, liquid polymer mucoadhesive carrier that prolongs the contact time between drug and mucosa, thus increasing bioavailability. It can be loaded with nearly any pharmaceutical preparation and delivered a variety of mucosal tissues. Reduced mucociliary clearance of intranasally-applied drugs is desirable to reduce the naturally-occurring washing out of topically applied medications.
The objective of the current Phase IV, randomized, double-blind, cross-over study, was to evaluate the frequency of use and efficacy of SINOL and SINOL + MucoAd™ (Sinol-M) and to demonstrate non-inferiority of Sinol-M versus the existing product Sinol.
Additionally, as most homeopathic drugs are not supported by prospective clinical data there is a belief among many mainstream healthcare practitioners, and some consumers that these products do not work. This study therefore provides an opportunity to demonstrate improved efficacy versus no treatment (during the run-in and washout phases).
- Conditions
- Allergic Rhinitis
- Being tested
- Sinol or Sinol-M nasal spray
- Keywords
- Allergic Rhinitis, Capsaicin, Homeopathic, Sinol, Sinol-M
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinol or Sinol-M nasal sprayDrug
Also called Capsaicin nasal spray
One spray in each nostril up to a maximum of 12 times / day on an "as needed" basis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sinol-M Receives: Drug: Sinol or Sinol-M nasal spray |
| 2 | Active comparator | Sinol Receives: Drug: Sinol or Sinol-M nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching)
Measured: twice daily for 28 days
Secondary outcomes (1)
Number of sprays of study drug used
Measured: twice daily for 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Strategic Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martha White, MD, Principal investigator, Institute for Allergy and Asthma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825656
- Sponsor's protocol ID
- SMAN-0708
- Acronym
- SMAN
- Status last verified
- Jan 2009
- First submitted
- 19 Jan 2009
- Last updated
- 23 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SINOL + MucoAd™ (SMAN) Evaluation Trial: A Double-Blind, Cross-Over Comparison of SINOL and SMAN in Subjects With Congestion Due to Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00825656
- Acronym / sponsor ID
- SMAN / SMAN-0708
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Capsaicin, Homeopathic, Sinol, Sinol-M
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Strategic BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 21 Jan 2009 (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 demonstrate the equivalence of two homeopathic capsaicin containing nasal sprays (Sinol-M™ and Sinol) in patients with nasal congestion due to allergic rhinitis.
Detailed description
Sinol is an FDA registered, capsaicin-based, over-the-counter homeopathic nasal spray used for the relief of allergy and sinus conditions. It is an all-natural product that the patient uses on an as-needed basis for up to 12 times daily.
Sinol has been available in the US since 2004. In 2009 a second generation product, Sinol-M will be launched. Sinol-M is identical to the original formula but also contains MucoAd MucoAd™ is a patented non-toxic, non-irritating, liquid polymer mucoadhesive carrier that prolongs the contact time between drug and mucosa, thus increasing bioavailability. It can be loaded with nearly any pharmaceutical preparation and delivered a variety of mucosal tissues. Reduced mucociliary clearance of intranasally-applied drugs is desirable to reduce the naturally-occurring washing out of topically applied medications.
The objective of the current Phase IV, randomized, double-blind, cross-over study, was to evaluate the frequency of use and efficacy of SINOL and SINOL + MucoAd™ (Sinol-M) and to demonstrate non-inferiority of Sinol-M versus the existing product Sinol.
Additionally, as most homeopathic drugs are not supported by prospective clinical data there is a belief among many mainstream healthcare practitioners, and some consumers that these products do not work. This study therefore provides an opportunity to demonstrate improved efficacy versus no treatment (during the run-in and washout phases).
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 |
|---|---|---|
| 1 | Experimental | Drug: Sinol or Sinol-M nasal spraySinol-M |
| 2 | Active comparator | Drug: Sinol or Sinol-M nasal spraySinol |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Willing to participate as indicated by providing written informed consent
- 12 years of age or older, of any gender and any race
- Have had a positive skin prick and/or intradermal test for a currently prevalent allergen within the past 5 years
- A history of allergic rhinitis, for at least 2 years
- Have undergone washout of all medications that could have an influence on the study
Key exclusion criteria (17 listed)
- any concurrent disease that could interfere with the investigation or evaluation of the study medications such as: rhinitis medicamentosa or large obstructive nasal polyps
- any other anatomic nasal deformity that could interfere with their participation in the study
- asthma, with the exception of mild intermittent asthma
- congestion that, in the opinion of the study investigator, could interfere with successful nasal drug administration/absorption (in either nostril)
- use of systemic corticosteroids (oral, parenteral, intravenous, rectal) or inhaled or ocular corticosteroids within the last 30 days
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 |
|---|---|---|
| Sinol or Sinol-M nasal sprayAlso: Capsaicin nasal sprayOne spray in each nostril up to a maximum of 12 times / day on an "as needed" basis | Drug | 1, 2 |
Primary outcome
Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching)
Time frame: twice daily for 28 days
1 secondary outcome
Number of sprays of study drug used
Time frame: twice daily for 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
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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.
Martha White, MD principal investigator
Institute for Allergy and Asthma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sinol or Sinol-M nasal spray in people with Allergic Rhinitis, run by Strategic Biosciences at 1 site in United States.
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 10 inclusion and 17 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 23 Jan 2009. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching) (time frame: twice daily for 28 days). 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 23 Jan 2009.