Rhinitis AllergicPhase 4NCT02175485
Evaluation of Efficacy of Dellegra in Exposure Unit
A Phase 4 study testing Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg in people with Rhinitis Allergic, run by Sanofi at 1 site in Japan.
Trial summary
Primary Objective: To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen exposure. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Rhinitis Allergic
- What is being tested?
- Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2014to Jun 2014
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with seasonal allergic rhinitis.
- Patients with a history of symptoms of Japanese cedar pollinosis for at least 2 years.
- Positive radioallergosorbent test (RAST) for Japanese cedar pollen antigen (CAP-RAST class >=2) within 1.5 years before the exposure test.
- Patients with Total Nasal Symptom Score of 8 or more, and nasal congestion scores of 2 (moderate) or more at least 1 assessment point of 90 to 150 minutes after the start of the screening exposure.
- Age ≥20 and ≤65 years.
- Patients written informed consent.
Who cannot join
- Patients with symptoms of perennial allergic rhinitis.
- Patients with severe asthma, bronchiectasis, severe hepatic, renal, or cardiac dysfunction, hematological, endocrine disease, and other serious complications.
- Patients with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, deviation of the nasal septum, etc.) or eye diseases that could interfere with judgment of the efficacy of Dellegra Combination Tablets.
- Patients with evidence of upper and/or lower respiratory tract inflammation (acute rhinitis, chronic rhinitis, congestive rhinitis, atrophic rhinitis, purulent nasal discharge, sinusitis in the presence of cold-like, etc.) on the day of treatment exposure.
- Patients who have taken any of the following medications that may affect the evaluation of Dellegra Combination Tablets (except for the use of topical preparation in which investigator/sub-investigator judged them not to affect the efficacy evaluation; the treated site is different, etc.):
- Within 2 weeks prior to the day of the screening exposure test: Antiallergic drugs, antihistamines (H1 and H2 blockers: oral administration, nose drops, eye drops, injection, and topical use), anticholinergic agents, vasoconstrictor nose drops, antihistamine-containing cold remedies, agents that can be expected to have an antiallergic/antihistaminic effect (including Chinese medicines and glycyrrhizin), and other agents that are indicated for allergic symptoms (sneezing, rhinorrhea, nasal congestion, and eye itching etc.). Steroids (oral, inhaled, nose drops, eye drops, or topical use), immunosuppressants (oral, topical use, or injected), azole fungicides, and histamine containing gamma-globulin preparations.
Show all 12Show fewer
- Within 4 weeks prior to the day of the screening exposure test: Depot steroid preparations.
- Patients who are considered by the investigator/sub-investigator to be unsuitable for enrollment in the study for any other criterion.
- Patients with a history of hypersensitivity to antihistamines or antihistaminic agent (fexofenadine HCI is included), and the pseudoephedrine hydrochloride.
- Patients with severe hypertension or severe coronary artery disease, narrow angle glaucoma, urinary retention, or those who have shown sensitivity to adrenergic agents (manifestations include insomnia, dizziness, weakness, tremor, or arrhythmias).
- Women who are pregnant, may be pregnant, or currently breast-feeding.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy of Dellegra® Combination Tablet (Fexofenadine Hydrochloride 30mg /Pseudoephedrine Hydrochloride 60mg) in Allergic Rhinitis After Japanese Cedar Antigen Exposure in Japanese Population. Open Label Study
Primary Objective:
To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen exposure.
Secondary Objective:
To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar pollen exposure.
Read the detailed description
It will be 8 days at minimum and up to 17 days depending on screening visit and post-treatment observation allowances.
- Conditions
- Rhinitis Allergic
- Being tested
- Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mgDrug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Fexofenadine HCl | Experimental | 2 tablets of Dellegra Combination Tablets (Fexofenadine Hydrochloride 30 mg+Pseudoephedrine Hydrochloride 60 mg/tablet), oral, administrated 2 hours after start of exposure with 8,000 grains/cubic meter of Japanese cedar pollen Receives: Drug: Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in Total Nasal Symptom Score (sneezing, nasal discharge, nasal congestion, and itchy nose
Measured: From 2 hours after antigen exposure (baseline) to 3 hours after intake of Dellegra
Secondary outcomes (3)
Mean change of Total Symptom Score (sneezing, nasal discharge, nasal congestion, itchy nose, lacrimation, and eye itching
Measured: Prior to exposure, and every 15 minutes for 5 hours after exposure start
Overall patients' impression about efficacy of Dellegra after Dellegra internal use (Score 1 [none] to 7 [very severe])
Measured: From intake of Dellegra up to 17 days
Number of patients who experienced adverse events
Measured: From intake of Dellegra up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis AllergicStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175485
- Sponsor's protocol ID
- FEXHYL06934
- Other IDs
- U1111-1152-0373
- Status last verified
- Dec 2015
- First submitted
- 22 Jun 2014
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Dellegra® Combination Tablet (Fexofenadine Hydrochloride 30mg /Pseudoephedrine Hydrochloride 60mg) in Allergic Rhinitis After Japanese Cedar Antigen Exposure in Japanese Population. Open Label Study
- ClinicalTrials.gov ID
- NCT02175485
- Acronym / sponsor ID
- FEXHYL06934
- Conditions
- Rhinitis Allergic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Jun 2014 (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.
Primary Objective:
To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen exposure.
Secondary Objective:
To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar pollen exposure.
Detailed description
It will be 8 days at minimum and up to 17 days depending on screening visit and post-treatment observation allowances.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fexofenadine HCl | Experimental | Drug: Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg2 tablets of Dellegra Combination Tablets (Fexofenadine Hydrochloride 30 mg+Pseudoephedrine Hydrochloride 60 mg/tablet), oral, administrated 2 hours after start of exposure with 8,000 grains/cubic meter of Japanese cedar pollen |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with seasonal allergic rhinitis.
- Patients with a history of symptoms of Japanese cedar pollinosis for at least 2 years.
- Positive radioallergosorbent test (RAST) for Japanese cedar pollen antigen (CAP-RAST class >=2) within 1.5 years before the exposure test.
- Patients with Total Nasal Symptom Score of 8 or more, and nasal congestion scores of 2 (moderate) or more at least 1 assessment point of 90 to 150 minutes after the start of the screening exposure.
- Age ≥20 and ≤65 years.
Key exclusion criteria (12 listed)
- Patients with symptoms of perennial allergic rhinitis.
- Patients with severe asthma, bronchiectasis, severe hepatic, renal, or cardiac dysfunction, hematological, endocrine disease, and other serious complications.
- Patients with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, deviation of the nasal septum, etc.) or eye diseases that could interfere with judgment of the efficacy of Dellegra Combination Tablets.
- Patients with evidence of upper and/or lower respiratory tract inflammation (acute rhinitis, chronic rhinitis, congestive rhinitis, atrophic rhinitis, purulent nasal discharge, sinusitis in the presence of cold-like, etc.) on the day of treatment exposure.
- Patients who have taken any of the following medications that may affect the evaluation of Dellegra Combination Tablets (except for the use of topical preparation in which investigator/sub-investigator judged them not to affect the efficacy evaluation; the treated site is different, etc.):
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 |
|---|---|---|
| Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mgPharmaceutical form:tablet Route of administration: oral | Drug | Fexofenadine HCl |
Primary outcome
Mean change in Total Nasal Symptom Score (sneezing, nasal discharge, nasal congestion, and itchy nose
Time frame: From 2 hours after antigen exposure (baseline) to 3 hours after intake of Dellegra
3 secondary outcomes
Mean change of Total Symptom Score (sneezing, nasal discharge, nasal congestion, itchy nose, lacrimation, and eye itching
Time frame: Prior to exposure, and every 15 minutes for 5 hours after exposure start
Overall patients' impression about efficacy of Dellegra after Dellegra internal use (Score 1 [none] to 7 [very severe])
Time frame: From intake of Dellegra up to 17 days
Number of patients who experienced adverse events
Time frame: From intake of Dellegra up to 17 days
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 18 Dec 2015.
Related trials for Rhinitis Allergic
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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.
Clinical Sciences & Operations study director
Sanofi
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 Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg in people with Rhinitis Allergic, run by Sanofi at 1 site in Japan.
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 12 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 18 Dec 2015. 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 Japan. 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?
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?
Mean change in Total Nasal Symptom Score (sneezing, nasal discharge, nasal congestion, and itchy nose (time frame: From 2 hours after antigen exposure (baseline) to 3 hours after intake of Dellegra). 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 18 Dec 2015.