Cat Induced Allergic RhinitisPhase 4NCT00637884
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study Designed to Evaluate the Efficacy of Fexofenadine HCl 180 mg for Preventing and Controlling Cat Allergy Symptoms
A Phase 4 study testing Fexofenadine HCl in people with Cat Induced Allergic Rhinitis, run by Sanofi.
Trial summary
This is a single-center, prospective, randomized, double-blind, placebo-controlled, two-way crossover study. A live cat challenge model will be used for exposing subjects to Fel d1. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cat Induced Allergic Rhinitis
- What is being tested?
- Fexofenadine HCl
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Feb 2004
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects, aged 12 years and older, inclusive
- History of cat-induced allergic rhinitis for at least 2 years, requiring the use of allergy medication or resulting in avoidance of cats
- Skin test positive to cat allergen at screening, defined as a wheal greater than one-half the diameter of the histamine control and at least 3 mm larger than the diameter of the glycerin-saline solution control. A skin test performed in the previous 15 months may be used to qualify the subject if it was performed at the investigator's site and recorded in the subject's medical record
- FEV1 greater than or equal to 80% of the predicted value on the screening assessment, and at the baseline assessment prior to the priming cat challenge(s). After the priming cat challenge, FEV1 must not have decreased >12% from the pre-challenge testing % predicted value
- Reversibility of <12% in absolute FEV1 following 2 puffs of albuterol at screening
- Minimal baseline allergic symptoms, defined as TSS less than or equal to 4 at the baseline assessments prior to the priming cat challenges
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- All females must have a negative urine pregnancy test
- Willing and able to adhere to visit schedules and all study requirements
- Mild to moderate allergic symptoms defined as TSS less than or equal to 8 at screening
Who cannot join
- Asthma that requires treatment with medication other than inhaled, short-acting beta-agonists (not to be taken within 6 hours prior to the priming visit(s) or Visits 3 or 4) or asthma known to be exacerbated by exposure to Fel d1. (Subjects with exercise-induced asthma will be allowed.)
- Requires medication for rhinitis that cannot be withheld
- Has a cat in the home (Subjects who have cats who are exclusively outdoors will be allowed.)
- Upper respiratory infection within 4 weeks of study entry
- History of severe reactions to cat exposure by self-report (severe is defined as being unable to tolerate cat exposure for at least 30 minutes)
- Acute or chronic sinusitis or other nasal diseases that resulted in nasal obstruction (e.g., nasal septum deviation, nasal polyps) within 4 weeks of study entry
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- Known hypersensitivity to fexofenadine HCl or to drugs with similar chemical structures
- Clinically significant ECG values that, in the judgment of the investigator, would have clinical implications for the subject's participation in the study
- Clinically significant medical condition (such as cardiovascular, hepatic, neurologic, hematological, renal, gastrointestinal, endocrine, or other major systemic disease), that, 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
- Pregnant or breast-feeding
- Likely to require treatment during the study period with drugs not permitted by the study protocol
- Immunotherapy, except those on a constant dose of immunotherapy that will be maintained throughout the study
- Treatment with an investigational agent or device within 30 days prior to study entry
- Recent history of alcohol or other drug abuse
- Mental condition that renders the subject unable to understand the nature, scope, and possible consequences of the study
- Unlikely to comply with the protocol (e.g., has an uncooperative attitude, is unlikely to complete the study)
- Subjects who are research employees or relatives of study site staff involved in this study or those who have or will read the protocol
About this study
This is a single-center, prospective, randomized, double-blind, placebo-controlled, two-way crossover study. A live cat challenge model will be used for exposing subjects to Fel d1. Subjects who test positive for cat allergy symptoms during a priming cat exposure challenge will be eligible to enter the treatment phase of the study. Baseline efficacy measures will be obtained prior to the dispensing of study medication during both treatment periods. Cat challenges will be initiated 1.5 hours following treatment with study medication.
- Conditions
- Cat Induced Allergic Rhinitis
- Being tested
- Fexofenadine HCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexofenadine HClDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine efficacy of fexofenadine HCl 180 mg versus placebo in preventing and controlling self-reported cat allergy symptoms in subjects who have a known allergy to cats and who are exposed to feline domesticus allergen 1
Secondary outcomes (1)
Determine efficacy of fexofenadine HCl 180 mg compared to placebo in subjects with a known allergy to cats
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 startNov 2003
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cat Induced 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
- 70 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
- NCT00637884
- Sponsor's protocol ID
- M016455A_4148
- 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 Single-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study Designed to Evaluate the Efficacy of Fexofenadine HCl 180 mg for Preventing and Controlling Cat Allergy Symptoms
- ClinicalTrials.gov ID
- NCT00637884
- Acronym / sponsor ID
- M016455A_4148
- Conditions
- Cat Induced Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Feb 2004 (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.
This is a single-center, prospective, randomized, double-blind, placebo-controlled, two-way crossover study. A live cat challenge model will be used for exposing subjects to Fel d1. Subjects who test positive for cat allergy symptoms during a priming cat exposure challenge will be eligible to enter the treatment phase of the study. Baseline efficacy measures will be obtained prior to the dispensing of study medication during both treatment periods. Cat challenges will be initiated 1.5 hours following treatment with study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects, aged 12 years and older, inclusive
- History of cat-induced allergic rhinitis for at least 2 years, requiring the use of allergy medication or resulting in avoidance of cats
- Skin test positive to cat allergen at screening, defined as a wheal greater than one-half the diameter of the histamine control and at least 3 mm larger than the diameter of the glycerin-saline solution control. A skin test performed in the previous 15 months may be used to qualify the subject if it was performed at the investigator's site and recorded in the subject's medical record
- FEV1 greater than or equal to 80% of the predicted value on the screening assessment, and at the baseline assessment prior to the priming cat challenge(s). After the priming cat challenge, FEV1 must not have decreased >12% from the pre-challenge testing % predicted value
- Reversibility of <12% in absolute FEV1 following 2 puffs of albuterol at screening
Key exclusion criteria (17 listed)
- Asthma that requires treatment with medication other than inhaled, short-acting beta-agonists (not to be taken within 6 hours prior to the priming visit(s) or Visits 3 or 4) or asthma known to be exacerbated by exposure to Fel d1. (Subjects with exercise-induced asthma will be allowed.)
- Requires medication for rhinitis that cannot be withheld
- Has a cat in the home (Subjects who have cats who are exclusively outdoors will be allowed.)
- Upper respiratory infection within 4 weeks of study entry
- History of severe reactions to cat exposure by self-report (severe is defined as being unable to tolerate cat exposure for at least 30 minutes)
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 | Drug | – |
Primary outcome
Determine efficacy of fexofenadine HCl 180 mg versus placebo in preventing and controlling self-reported cat allergy symptoms in subjects who have a known allergy to cats and who are exposed to feline domesticus allergen 1
1 secondary outcome
Determine efficacy of fexofenadine HCl 180 mg compared to placebo in subjects with a known allergy to cats
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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fexofenadine HCl in people with Cat Induced Allergic Rhinitis, run by Sanofi.
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 17 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.
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?
Determine efficacy of fexofenadine HCl 180 mg versus placebo in preventing and controlling self-reported cat allergy symptoms in subjects who have a known allergy to cats and who are exposed to feline domesticus allergen 1. 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.