Seasonal Allergic RhinitisPhase 2NCT01940146
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
A Phase 2 study testing SPARC1310 I, SPARC1310 II and SPARC1310 III in people with Seasonal Allergic Rhinitis, run by Sun Pharma Advanced Research Company Limited at 1 site in Canada.
Trial summary
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- SPARC1310 I, SPARC1310 II and SPARC1310 III
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 to 65 years with history of seasonal allergic rhinitis
- Participants able to understand and willing to sign the informed consent form
Who cannot join
- Anotomical deviations of the nasal septum that significantly impair ventilation or airflow
- Pregnant or nursing women
- Positive serology for infectious disease (Hepatitis B or C, HIV) at screening
- Parallel participation in another current investigational study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study.
Trial locations and contacts
1 site in 1 country.
About this study
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- SPARC Placebo, SPARC1310 I, SPARC1310 II, SPARC1310 III
- 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.
SPARC PlaceboDrug
Placebo
SPARC1310 IDrug
SPARC1310 I
SPARC1310 IIDrug
SPARC1310 II
SPARC1310 IIIDrug
SPARC1310 III
| Study group | Role | What they receive |
|---|---|---|
| SPARC Placebo | Placebo comparator | Not described Receives: Drug: SPARC Placebo |
| SPARC1310 I | Experimental | Not described Receives: Drug: SPARC1310 I |
| SPARC1310 II | Experimental | Not described Receives: Drug: SPARC1310 II |
| SPARC1310 III | Experimental | Not described Receives: Drug: SPARC1310 III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Nasal Symptom Score From Baseline to Day 14.
The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.
Measured: Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shravanti Bhowmik, MD, Study director, Sun Pharma Advanced Research Company Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940146
- Sponsor's protocol ID
- CLR_13_10
- Status last verified
- May 2019
- First submitted
- 6 Sep 2013
- Last updated
- 3 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ellis AK, Steacy LM, Joshi A, Bhowmik S, Raut A. Efficacy of the novel nasal steroid S0597 tested in an environmental exposure unit. Ann Allergy Asthma Immunol. 2016 Sep;117(3):310-7. doi: 10.1016/j.anai.2016.07.018.
PubMed 27613466
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01940146
- Acronym / sponsor ID
- CLR_13_10
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Posted 11 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SPARC Placebo | Placebo comparator | Drug: SPARC Placebo |
| SPARC1310 I | Experimental | Drug: SPARC1310 I |
| SPARC1310 II | Experimental | Drug: SPARC1310 II |
| SPARC1310 III | Experimental | Drug: SPARC1310 III |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female participants aged 18 to 65 years with history of seasonal allergic rhinitis
- Participants able to understand and willing to sign the informed consent form
Key exclusion criteria (4 listed)
- Anotomical deviations of the nasal septum that significantly impair ventilation or airflow
- Pregnant or nursing women
- Positive serology for infectious disease (Hepatitis B or C, HIV) at screening
- Parallel participation in another current investigational study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study.
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 |
|---|---|---|
| SPARC PlaceboPlacebo | Drug | SPARC Placebo |
| SPARC1310 ISPARC1310 I | Drug | SPARC1310 I |
| SPARC1310 IISPARC1310 II | Drug | SPARC1310 II |
| SPARC1310 IIISPARC1310 III | Drug | SPARC1310 III |
Primary outcome
Change in Total Nasal Symptom Score From Baseline to Day 14.
Time frame: Baseline to Day 14
The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27613466Ellis AK, Steacy LM, Joshi A, Bhowmik S, Raut A. Efficacy of the novel nasal steroid S0597 tested in an environmental exposure unit. Ann Allergy Asthma Immunol. 2016 Sep;117(3):310-7. doi: 10.1016/j.anai.2016.07.018.
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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.
Shravanti Bhowmik, MD study director
Sun Pharma Advanced Research Company Limited
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 SPARC1310 I, SPARC1310 II and SPARC1310 III in people with Seasonal Allergic Rhinitis, run by Sun Pharma Advanced Research Company Limited at 1 site in Canada.
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 2 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 3 May 2019. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Total Nasal Symptom Score From Baseline to Day 14. (time frame: Baseline to Day 14). 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 NCT01940146, which also lists 1 linked publication.
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 3 May 2019.