Seasonal Allergic RhinitisPhase 4NCT00637611
Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit
A Phase 4 study testing Fexofenadine HCl in people with Seasonal Allergic Rhinitis, run by Sanofi at 1 site in United States.
Trial summary
The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine hydrochloride 180 mg, montelukast sodium 10 mg, and placebo Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Fexofenadine HCl
- How many people
- 1,010 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Apr 2003
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects, 15 years of age or older
- History of seasonal allergic rhinitis (SAR) during the fall pollen season, for at least the previous 2 years
- History of having a positive response to antihistamines for symptoms of SAR
- Must be skin test positive to ragweed within the last 15 months with at least a moderate reaction as defined by a wheal 7 mm greater than the diluent wheal after intradermal skin test or a wheal 5 mm greater than the diluent wheal after skin prick test. A skin test performed in the previous 15 months may be used to qualify the patient if it was performed at the investigator's site and recorded in the subject's medical record
- All females must have negative urine pregnancy test at screening visit
- Willing and able to adhere to visit schedules and all study requirements
Who cannot join
- Clinically significant medical condition (such as cardiovascular, hepatic, neurologic, hematological, renal, gastrointestinal, endocrine, or other major systemic disease), which, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult
- Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist or asthma that will be exacerbated by exposure to ragweed pollen
- Pregnancy or breast-feeding
- History of hypersensitivity to the study medications or to drugs with similar chemical structures
- Nasal structural abnormalities, including large nasal polyps or marked septal deviation, that significantly interfere with nasal air flow
- Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
Show all 15Show fewer
- Upper or lower respiratory infection within 14 days of the first priming visit
- Diagnosis of sinusitis within 30 days of the first priming visit
- Immunotherapy, except those on a constant dose of immunotherapy that will be maintained throughout the study
- Treatment with any investigational drug in the last 30 days before study entry
- Recent history of drug or alcohol abuse
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Unlikelihood to comply with protocol such as those with uncooperative attitude or the inability to return for follow-up visits or to complete the study
- Subjects who were randomized into this trial will not be eligible to participate in another fexofenadine hydrochloride 180 mg vs montelukast sodium 10 mg onset of action study (planned to be conducted in 2003)
- Subjects who are research employees or relatives of study site staff involved in this study or those who have or will read the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit (Study I)
The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine hydrochloride 180 mg, montelukast sodium 10 mg, and placebo
- 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.
To determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo in the treatment of subjects with moderately severe seasonal allergic rhinitis (SAR) in a controlled setting.
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 startFeb 2003
- Study completionApr 2003
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,010 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
- NCT00637611
- Sponsor's protocol ID
- M016455A_4149
- Status last verified
- Jan 2011
- First submitted
- 10 Mar 2008
- Last updated
- 12 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit (Study I)
- ClinicalTrials.gov ID
- NCT00637611
- Acronym / sponsor ID
- M016455A_4149
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Apr 2003 (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.
The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine hydrochloride 180 mg, montelukast sodium 10 mg, and placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female subjects, 15 years of age or older
- History of seasonal allergic rhinitis (SAR) during the fall pollen season, for at least the previous 2 years
- History of having a positive response to antihistamines for symptoms of SAR
- Must be skin test positive to ragweed within the last 15 months with at least a moderate reaction as defined by a wheal 7 mm greater than the diluent wheal after intradermal skin test or a wheal 5 mm greater than the diluent wheal after skin prick test. A skin test performed in the previous 15 months may be used to qualify the patient if it was performed at the investigator's site and recorded in the subject's medical record
- All females must have negative urine pregnancy test at screening visit
Key exclusion criteria (15 listed)
- Clinically significant medical condition (such as cardiovascular, hepatic, neurologic, hematological, renal, gastrointestinal, endocrine, or other major systemic disease), which, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult
- Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist or asthma that will be exacerbated by exposure to ragweed pollen
- Pregnancy or breast-feeding
- History of hypersensitivity to the study medications or to drugs with similar chemical structures
- Nasal structural abnormalities, including large nasal polyps or marked septal deviation, that significantly interfere with nasal air flow
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
To determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo in the treatment of subjects with moderately severe seasonal allergic rhinitis (SAR) in a controlled setting.
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 12 Jan 2011.
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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.
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 6 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 12 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?
To determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo in the treatment of subjects with moderately severe seasonal allergic rhinitis (SAR) in a controlled setting.. 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 12 Jan 2011.