Allergic RhinitisPhase 4NCT00638118
Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen
A Phase 4 study testing Fexofenadine in people with Allergic Rhinitis, run by Sanofi at 1 site in United States.
Trial summary
Examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (Allegra) and montelukast sodium 10 mg (Singulair) as compared to placebo on skin wheals and flares induced by seasonal allergen. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Fexofenadine
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to May 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 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female subjects, 15 to 55 years of age, may participate.
- Subjects with a history of seasonal allergic rhinitis (due to ragweed; oak, elm or maple; or grasses) for the previous 2 years.
- Positive seasonal allergen skin prick tests (or duplicate seasonal allergen skin prick test) with a summation flare greater than or equal to 20 mm larger than diluent control, and summation wheal greater than or equal to 6 mm larger than diluent control at the screening visit 1 (see Appendix 17.1); the seasonal allergen testing that results in the greatest summation flare will be used for all subsequent seasonal allergen testing.
- All female subjects must have a negative urine pregnancy test at the screening visit.
- Female subjects who are sexually active will be expected to use one of the following birth control methods throughout the study.
- Subjects must be within 15% of normal body weight for height or a BMI less than 29.9 (based on NHLBI guidelines).
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- Subjects willing and able to adhere to visit schedules and all study requirements.
- All female subjects must have a negative urine pregnancy test at each treatment visit (Visit 2, 4, and 6).
- Continues to meet all inclusion and exclusion criteria.
Who cannot join
- Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist.
- Significant signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis).
- Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1.
- Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results.
- Subjects who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy.
- Any excessive amounts of alcohol (no more than two drinks/day on average).
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- Any excessive use of caffeine (more than six 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 visit 1.
- Any disease state or surgery known to affect the gastrointestinal absorption of drugs.
- Known hypersensitivity to the investigational product or to drugs with similar chemical properties.
- Subjects who will be visiting a tanning salon during the study.
- Subjects who will need to use artificial tanning products during the study.
- Pregnancy.
- Breast-feeding.
- Regular treatment with other H1-receptor antagonists in the last year before study entry.
- No person or child of a person directly associated with the administration of the study may participate as a study subject.
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
- Treatment with any investigational product in the last 30 days before study entry.
- Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- Use of any of the following drugs within the time indicated prior to the first dosing visit: Systemic or injected corticosteroids (including oral, parenteral, intravenous, rectal) 30 days; Nasal or inhaled or ocular corticosteroids 30 days; Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal, inhaled, or ophthalmic sodium cromolyn 14 days; Agents with antihistaminic/anticholinergic activity (e.g. antidepressants, antipsychotics) 14 days; Leukotriene pathway modifiers (Accolate, Singulair, Zyflo) 10 days; Ocular anti-allergy medications including lodoxamide (Alomide), olopatadine (Patanol), emedastine difumarate (Emadine), levocabastine (Livostin) 10 days; Non-steroidal anti-inflammatory ophthalmics including ketorolac (Acular), flurbiprofen (Ocufen), suprofen (Profenal), diclofenac (Voltaren) 10 days; Antihistamines including desloratadine (Clarinex), loratadine (Claritin) 10 days; Antihistamines including fexofenadine HCl (Allegra), cetirizine (Zyrtec), hydroxyzine, azelastine nasal spray (Astelin), clemastine 7 days; Other short-acting antihistamines such as chlorpheniramine or drugs with antihistaminic activity 3 days; OTC oral antihistamines, decongestants (includes pseudoephedrine and other decongestants), or antihistamines/decongestant combinations including all cold, cough, and sleep aids 3 days; OTC ophthalmic decongestant,antihistamine, or decongestant/antihistamine combinations 3 days; Other anticholinergic agents 3 days; Immunotherapy injection 1 day.
- Other drugs should only be permitted if they are not expected to interfere with the ability of the subject to participate in the study.
- Non-steroidal anti-inflammatory agents are not allowed for 2 days prior to each treatment visit day through 25 hours post-dose (low-dose cardiac prophylaxis is allowed).
- Use of any medications or agents that are not specified above that may confound the interpretation of the results:
- Caffeine within 6 hours prior to each visit (coffee, tea, cola, and sodas, including Mountain Dew and Surge)
- Decaffeinated coffee, tea and colas within 6 hours of each visit
- Alcohol within 24 hours prior to each study visit
- Chocolate within 6 hours prior to each visit
- Antacids within +/- minus2 hours of investigational product dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen
Examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (Allegra) and montelukast sodium 10 mg (Singulair) as compared to placebo on skin wheals and flares induced by seasonal allergen.
- Conditions
- Allergic Rhinitis
- Being tested
- Fexofenadine
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FexofenadineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of change in skin flares from baseline will be measured.
Measured: Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24)
Secondary outcomes (1)
Size of change in skin wheals from baseline will be measured.
Measured: Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24)
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 completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 48 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
- NCT00638118
- Sponsor's protocol ID
- M016455A_4146
- 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
- A Comparison of Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen
- ClinicalTrials.gov ID
- NCT00638118
- Acronym / sponsor ID
- M016455A_4146
- Conditions
- Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- May 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.
Examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (Allegra) and montelukast sodium 10 mg (Singulair) as compared to placebo on skin wheals and flares induced by seasonal allergen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Male and female subjects, 15 to 55 years of age, may participate.
- Subjects with a history of seasonal allergic rhinitis (due to ragweed; oak, elm or maple; or grasses) for the previous 2 years.
- Positive seasonal allergen skin prick tests (or duplicate seasonal allergen skin prick test) with a summation flare greater than or equal to 20 mm larger than diluent control, and summation wheal greater than or equal to 6 mm larger than diluent control at the screening visit 1 (see Appendix 17.1); the seasonal allergen testing that results in the greatest summation flare will be used for all subsequent seasonal allergen testing.
- All female subjects must have a negative urine pregnancy test at the screening visit.
- Female subjects who are sexually active will be expected to use one of the following birth control methods throughout the study.
Key exclusion criteria (31 listed)
- Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist.
- Significant signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis).
- Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1.
- Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results.
- Subjects who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy.
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 | Drug | – |
Primary outcome
Size of change in skin flares from baseline will be measured.
Time frame: Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24)
1 secondary outcome
Size of change in skin wheals from baseline will be measured.
Time frame: Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24)
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.
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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 in people with 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 9 inclusion and 31 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?
Size of change in skin flares from baseline will be measured. (time frame: Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24)). 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.