Rhinitis AllergicPhase 3NCT02401191
A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic Rhinitis
A Phase 3 study testing FEX60/PE10 in people with Rhinitis Allergic, run by Sanofi at 1 site in Japan.
Trial summary
Primary Objective: To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis. Secondary Objective: To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Rhinitis Allergic
- What is being tested?
- FEX60/PE10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2015to Jul 2015
- Phase
- Phase 3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Outpatients with a history of seasonal or perennial allergic rhinitis for at least 1 year confirmed by positive skin prick test to out or indoor allergens (wheal ≥3mm compared to control [diluent]) or positive specific IgE Antibody test (ie, radioallergosorbent test [RAST], etc.) on the day of provisional inclusion in the trial.
- Patients who meet the following criteria of symptom score. (The symptom score is rated according to the 'Severity of nasal symptoms'):
- Nasal congestion score is consistently from 2 to 3 but not 4 for the last 3 days of the screening period.
- Score of sneezing or rhinorrhea is consistently 2 or 3 but not 4 throughout the last 3 days of the screening period.
- Patients aged 15 years or older, with no restriction on gender.
- Patients written informed consent.
- Females with childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of study drug and adequate contraception during the study.
Who cannot join
- Patients with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, acute rhinitis, deviation of the nasal septum, etc.) that could interfere with judgment of the efficacy of the investigational product (IP) and patients developing cold-like symptoms during screening period.
- Patients with severe asthma, bronchiectasis, severe hepatic, renal, or cardiac dysfunction, hematological, endocrine disease, and other serious complications.
- Patients with unstable medical conditions like diabetes mellitus, heart failure, hepatic and renal impairment.
- Patients with a history of epilepsy or with organic brain disease, which may cause epilepsy.
- Patients who have taken any of the following medications that may affect the evaluation of the IP, Patients using intranasal or systemic decongestants if they are not stopped 3 days before the inclusion visit.
- Within 1 week prior to the day of registration:
Show all 24Show fewer
- Intranasal or oral:
- Antiallergic drugs, antihistamines, anticholinergic agents, vasoconstrictor, 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, etc.).
- Agents that may affect the blood concentration of Fexofenadine (FEX) (macrolide antibiotics, azole fungicides, and preparations containing aluminum hydroxide/magnesium hydroxide).
- Within 2 weeks prior to the day of registration:
- o Steroids, immunosuppressant, and nonspecific alternative therapy (histamine-containing gamma-globulin preparations etc).
- Within 4 weeks prior to the day of registration:
- Patients receiving oral, nasal, inhaled corticosteroids.
- Depot steroid preparations.
- Patients using sodium cromoglycate/nedocromil or leukotriene modifiers if they are not stopped 14 days before the inclusion.
- Patients under immunotherapy if specific immunotherapy has been started or dose changed approximately 1 month preceding enrolment in the study, (doses should maintain the same dose throughout the trial).
- Patients suffering from Upper Respiratory Tract Infection, sinusitis or acute otitis media within 30 days before the inclusion visit.
- Patients who are participating in another study or who have previously participated in another study within the previous 6 months prior to the day of registration.
- Patients who are considered by the Investigator/sub-investigator to be unsuitable for enrolment in the study for any other criterion or previously participated in this study.
- Patients with a history of hypersensitivity to antihistamines or antiallergic agents including FEX.
- 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).
- Patients receiving monoamine oxidase (MAO) inhibitor therapy or within 2 weeks prior to the day of registration.
- Women who are pregnant, possibly pregnant, or breast-feeding.
- Patients with underlying hepatobiliary disease. 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: A Non-controlled, Open Study for Assessing the Safety and Effectiveness of a Twice-daily FEX 60 mg - PE 10 mg (FEX60/PE10) Fixed Combination Tablet in Patients With Allergic Rhinitis
Primary Objective:
To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis.
Secondary Objective:
To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.
Read the detailed description
It will be 22 days at minimum and up to 32 days depending on screening, treatment, and post-treatment observation allowances.
- Conditions
- Rhinitis Allergic
- Being tested
- FEX60/PE10
- 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.
FEX60/PE10Drug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| FEX60/PE10 | Experimental | Internal use of FEX60/PE10 combination tablet will be administered twice daily (1 tablet per intake) for 2 weeks Receives: Drug: FEX60/PE10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (Solicited AE reporting)
Measured: From intake of FEX60/PE10 up to approximately 2 weeks
Changes from baseline in the nasal congestion score based on the patient's symptom diary
Measured: After 2 weeks treatment
Secondary outcomes (12)
Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)
Measured: After 2 weeks treatment
Change in the total score of 3 nasal symptoms on a daily basis
Measured: After 2 weeks treatment
Change in the total score of 3 nasal symptoms during daytime
Measured: After 2 weeks treatment
Change in the total score of 3 nasal symptoms during night-time
Measured: After 2 weeks treatment
Change in the daily activity impairment score
Measured: After 2 weeks treatment
Change in the daily activity impairment score on a daily basis
Measured: After 2 weeks treatment
Change in the daily activity impairment score during daytime
Measured: After 2 weeks treatment
Change in the daily activity impairment score during night-time
Measured: After 2 weeks treatment
Change in nasal findings from baseline: color of inferior turbinate mucosa
Measured: After 2 weeks treatment
Change in nasal findings from baseline: congestion of inferior turbinate mucosa
Measured: After 2 weeks treatment
Change in nasal findings from baseline: consistency of discharge
Measured: After 2 weeks treatment
Assessment of patient's impression after treatment based on patient's symptom diary
Measured: After 2 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 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
- NCT02401191
- Sponsor's protocol ID
- FEXHYL07477
- Status last verified
- Nov 2015
- First submitted
- 24 Mar 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-controlled, Open Study for Assessing the Safety and Effectiveness of a Twice-daily FEX 60 mg - PE 10 mg (FEX60/PE10) Fixed Combination Tablet in Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02401191
- Acronym / sponsor ID
- FEXHYL07477
- Conditions
- Rhinitis Allergic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Mar 2015 (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 assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis.
Secondary Objective:
To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.
Detailed description
It will be 22 days at minimum and up to 32 days depending on screening, treatment, 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 |
|---|---|---|
| FEX60/PE10 | Experimental | Drug: FEX60/PE10Internal use of FEX60/PE10 combination tablet will be administered twice daily (1 tablet per intake) for 2 weeks |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Outpatients with a history of seasonal or perennial allergic rhinitis for at least 1 year confirmed by positive skin prick test to out or indoor allergens (wheal ≥3mm compared to control [diluent]) or positive specific IgE Antibody test (ie, radioallergosorbent test [RAST], etc.) on the day of provisional inclusion in the trial.
- Patients who meet the following criteria of symptom score. (The symptom score is rated according to the 'Severity of nasal symptoms'):
- Patients aged 15 years or older, with no restriction on gender.
- Patients written informed consent.
- Females with childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of study drug and adequate contraception during the study.
Key exclusion criteria (24 listed)
- Patients with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, acute rhinitis, deviation of the nasal septum, etc.) that could interfere with judgment of the efficacy of the investigational product (IP) and patients developing cold-like symptoms during screening period.
- Patients with severe asthma, bronchiectasis, severe hepatic, renal, or cardiac dysfunction, hematological, endocrine disease, and other serious complications.
- Patients with unstable medical conditions like diabetes mellitus, heart failure, hepatic and renal impairment.
- Patients with a history of epilepsy or with organic brain disease, which may cause epilepsy.
- Patients who have taken any of the following medications that may affect the evaluation of the IP, Patients using intranasal or systemic decongestants if they are not stopped 3 days before the inclusion 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 |
|---|---|---|
| FEX60/PE10Pharmaceutical form:tablet Route of administration: oral | Drug | FEX60/PE10 |
Primary outcome
Number of adverse events (Solicited AE reporting)
Time frame: From intake of FEX60/PE10 up to approximately 2 weeks
Changes from baseline in the nasal congestion score based on the patient's symptom diary
Time frame: After 2 weeks treatment
12 secondary outcomes
Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)
Time frame: After 2 weeks treatment
Change in the total score of 3 nasal symptoms on a daily basis
Time frame: After 2 weeks treatment
Change in the total score of 3 nasal symptoms during daytime
Time frame: After 2 weeks treatment
Change in the total score of 3 nasal symptoms during night-time
Time frame: After 2 weeks treatment
Change in the daily activity impairment score
Time frame: After 2 weeks treatment
Change in the daily activity impairment score on a daily basis
Time frame: After 2 weeks treatment
Change in the daily activity impairment score during daytime
Time frame: After 2 weeks treatment
Change in the daily activity impairment score during night-time
Time frame: After 2 weeks treatment
Change in nasal findings from baseline: color of inferior turbinate mucosa
Time frame: After 2 weeks treatment
Change in nasal findings from baseline: congestion of inferior turbinate mucosa
Time frame: After 2 weeks treatment
Change in nasal findings from baseline: consistency of discharge
Time frame: After 2 weeks treatment
Assessment of patient's impression after treatment based on patient's symptom diary
Time frame: After 2 weeks treatment
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 30 Nov 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 3 study testing FEX60/PE10 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 7 inclusion and 24 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 30 Nov 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of adverse events (Solicited AE reporting) (time frame: From intake of FEX60/PE10 up to approximately 2 weeks). The study lists 2 primary outcomes in all. 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 30 Nov 2015.