Seasonal Allergic RhinitisPhase 4NCT00637455
Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel
A Phase 4 study testing fexofenadine HCl in people with Seasonal Allergic Rhinitis, run by Sanofi at 1 site in United States.
Trial summary
To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized objective measure of attention, accuracy and reaction time in healthy naval flight personnel. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- fexofenadine HCl
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jan 2005
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female naval flight personnel, ≥18 years of age
- CogScreen-AE Logistic Regression Probability Value < 0.6 at the baseline screening visit
- Normal SaO2 (>95%) as measured by pulse oximetry
- Female subjects must be of nonchildbearing potential (i.e., surgically sterile or at least 1 year postmenopausal); see Section 4.4 for additional information:
Who cannot join
- Female subjects who are pregnant, lactating, or likely to become pregnant during the study
- Signs or symptoms of currently active allergic disease (seasonal allergic rhinitis, perennial allergic rhinitis, episodic allergic rhinitis) within 2 weeks prior to the screening visit
- Upper respiratory tract infection, sinusitis, asthma exacerbation, or flu-like symptoms within 2 weeks prior to the screening visit
- Medical history or physical examination findings; clinically significant cardiovascular, respiratory, hepatic, neurologic, endocrine, psychiatric, or other major systemic disease; or laboratory or electrocardiograph abnormality making implementation of the protocol or interpretation of the protocol results difficult. Abnormalities which are not clinically significant will not necessarily disqualify subjects provided, in the opinion of the investigator and sponsor, the study validity or the subject's welfare is not compromised.
- Any unusual sleep pattern, including third-shift workers (11:00 PM to 7:00 AM), or sleep < 6 hours the night before each AVT testing at Visits 1-4
- Any excessive amounts of alcohol (no more than two drinks/day on average)
Show all 15Show fewer
- Any excessive use of caffeine (more than three cups of coffee per day or equivalent)
- Any history of chronic alcohol or mood-altering drug abuse
- Any use of tobacco/nicotine products within 90 days of the screening visit or during the study
- Any disease state or surgery known to affect the gastrointestinal absorption of drugs
- Mental capacity limited to the extent the subject cannot give legal informed consent or accurate information regarding efficacy and side effects/tolerance of drug
- Subjects unable to comply with the protocol requirements (must complete a screening visit and Visits 1-4 within approximately 1-1/2 months)
- Known hypersensitivity to fexofenadine, or the tablet ingredients (croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch; or the tablet coating made of hydroxypropyl methylcellulose, iron oxide blends, polyethylene glycol, povidone, silicone dioxide, and titanium dioxide)
- Known hypersensitivity to cetirizine or the tablet ingredients (lactose, magnesium stearate, povidone, titanium dioxide, hydroxypropyl methylcellulose, polyethylene glycol, and corn starch)
- Use of an investigational drug within 30 days prior to Visit 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center, Randomized,Double-Blind,Crossover Study Comparing the Effects of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel
To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized objective measure of attention, accuracy and reaction time in healthy naval flight personnel. Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks) mean change from baseline in total number of errors (commission errors + omission errors) between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also will be assessed.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- fexofenadine HCl
- 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.
fexofenadine HClDrug
Also called Allegra
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the AVT overall mean challenge from baseline between Fexofenadine HCl & Cetirizine
Secondary outcomes (1)
Evaluating change from baseline between Fexofenadine HCl and Cetirizine on the endpoint of total # of errors under each normobaric hypoxic condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startSep 2003
- Study completionJan 2005
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Phyllis Diener, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637455
- Sponsor's protocol ID
- M016455A/4139
- Status last verified
- Jan 2011
- First submitted
- 10 Mar 2008
- Last updated
- 11 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Randomized,Double-Blind,Crossover Study Comparing the Effects of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel
- ClinicalTrials.gov ID
- NCT00637455
- Acronym / sponsor ID
- M016455A/4139
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Jan 2005 (actual)
- First posted
- 18 Mar 2008 (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.
To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized objective measure of attention, accuracy and reaction time in healthy naval flight personnel. Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks) mean change from baseline in total number of errors (commission errors + omission errors) between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female naval flight personnel, ≥18 years of age
- CogScreen-AE Logistic Regression Probability Value < 0.6 at the baseline screening visit
- Normal SaO2 (>95%) as measured by pulse oximetry
- Female subjects must be of nonchildbearing potential (i.e., surgically sterile or at least 1 year postmenopausal); see Section 4.4 for additional information:
Key exclusion criteria (15 listed)
- Female subjects who are pregnant, lactating, or likely to become pregnant during the study
- Signs or symptoms of currently active allergic disease (seasonal allergic rhinitis, perennial allergic rhinitis, episodic allergic rhinitis) within 2 weeks prior to the screening visit
- Upper respiratory tract infection, sinusitis, asthma exacerbation, or flu-like symptoms within 2 weeks prior to the screening visit
- Medical history or physical examination findings; clinically significant cardiovascular, respiratory, hepatic, neurologic, endocrine, psychiatric, or other major systemic disease; or laboratory or electrocardiograph abnormality making implementation of the protocol or interpretation of the protocol results difficult. Abnormalities which are not clinically significant will not necessarily disqualify subjects provided, in the opinion of the investigator and sponsor, the study validity or the subject's welfare is not compromised.
- Any unusual sleep pattern, including third-shift workers (11:00 PM to 7:00 AM), or sleep < 6 hours the night before each AVT testing at Visits 1-4
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 HClAlso: Allegra | Drug | – |
Primary outcome
Compare the AVT overall mean challenge from baseline between Fexofenadine HCl & Cetirizine
1 secondary outcome
Evaluating change from baseline between Fexofenadine HCl and Cetirizine on the endpoint of total # of errors under each normobaric hypoxic condition
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 11 Jan 2011.
Related trials for Seasonal Allergic Rhinitis
Not yet recruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
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.
Phyllis Diener 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 in people with Seasonal Allergic Rhinitis, run by Sanofi 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 4 inclusion and 15 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 11 Jan 2011. 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?
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?
Compare the AVT overall mean challenge from baseline between Fexofenadine HCl & Cetirizine. 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 11 Jan 2011.