Rhinitis, Allergic, PerennialPhase 3NCT02182518
Epinastine + Pseudoephedrine SR (Slow Release) Versus Epinastine Alone in Patients With Perennial Allergic Rhinitis
A Phase 3 study testing Epinastine and Pseudoephedrine in people with Rhinitis, Allergic, Perennial, run by Boehringer Ingelheim.
Trial summary
The aim of this trial is to evaluate the clinical efficacy and safety of Epinastine 10 mg + Pseudoephedrine 120 mg slow release (SR) administered twice a day, compared to Epinastine 10 mg alone administered twice daily. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Epinastine and Pseudoephedrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Jul 2001
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female outpatients
- Over 12 years old
- Patients who have granted their written informed consent, personally or by a legal representative, to be part of the study and in accomplishment of the model of informed consent approved by the Ethic Committee of the institution
- Patients with an established diagnosis of allergic perennial rhinitis under the clinical criteria (allergic to one or more allergens)
- Patients with moderate or complete nasal blockage characterizes by ≥50 mm in the VAS for this parameter during visits 1 and 2
- Patients with positive (≥3 mm compared to the negative control) skin test ("Prick Test") to one or more of the following allergens:
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- Dermatophagoides pteronyssinus
- Dermatophagoides farinae
- Blomia tropicalis
- Alternaria alternata
- Cladosporium herbarum
- Aspergillus fumigatus
- Penicillium notatum
- cat's fur
- dog's fur
Who cannot join
- Pregnant or breast feeding women, or women without contraceptive method who:
- are not in the postmenopausal period and/or
- have not been submitted to bilateral tubal ligation or hysterectomy and/or
- are not under one of the following contraceptive control:
- oral contraceptive
- IUD (intrauterine device)
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- diaphragm
- Patients unable to understand, accept or follow the protocol instructions
- History of serious adverse events with antihistamines
- Patients under treatment with calcium antagonists or other antihypertensive drugs
- Patients under treatment with digitalis
- Patients under treatment with MAO (monoamine oxidase) inhibitors
- Patients under treatment with sympathicomimetics
- Patients that have received any of the following drugs during the periods specified below, before visit 1:
- Inhaled/Topics
- short acting β2 agonists (12 hours)
- long acting β2 agonists (48 hours)
- ipratropium bromide (12 hours)
- nasal drops without vasoconstrictors (3 days)
- DSCG (disodium cromoglycate) (3 days)
- nedocromil (7 days)
- nasal drops with vasoconstrictors (7 days)
- azelastine (14 days)
- levocabastine (14 days)
- corticosteroids (30 days)
- corticosteroids on the site of Prick test (3 months)
- other investigational drug (3 months)
- Oral
- short acting β2 agonists (18 hours)
- short acting theophylline (24 hours)
- phenothiazines (48 hours)
- long acting theophylline (72 hours)
- anticholinergics (7 days)
- antihistamines (except astemizole) (7 days)
- MAO (monoamine oxidase) inhibitors (14 days)
- corticosteroids (30 days)
- ketotifen (3 months)
- imipramine (30 days)
- astemizole (2 months)
- other investigational drugs (3 months)
- Parenteral
- aminophylline (24 hours)
- phenothiazines (48 hours)
- antihistamines (7 days)
- corticosteroids (30 days)
- imipramine (30 days)
- other investigational drugs (3 months)
- Patients under desensitization therapy
- Patients under therapy with antibiotics
- Patients with non compensate endocrine disease
- Patients with atrophic rhinitis
- Patients with rhinitis due to acetylsalicylic acid
- Patients with acute or chronic infectious sinusitis
- Patients with asthma, that need treatment with beta-2 agonists more than twice per week
- Patients with glaucoma
- Patients with history or renal and/or hepatic failure
- Patients with known platelets dysfunction due to any disease or to drugs (purpura thrombocytopenic idiopathic, use of anticoagulants, use of antiplatelets drugs)
- Patients with any oncological disease
- Patients with nasal septal deviation causing alteration of the nasal flux, polyps, anatomic/structural alterations (ex., tumors, leishmaniosis, etc.)
- Patients with any cardiovascular disease
- Patients with arterial hypertension
- Patients requiring halogenates anesthetics
- Patients with diabetes mellitus
- Patients with hyperthyroidism
- Patients with prostatic hypertrophy
- Patients with epilepsy or any other seizure
About this study
Official title: Double-blind, Randomized, Parallel Trial to Evaluate the Clinical Efficacy and Safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, Twice a Day, Versus Epinastine 10 mg Alone, Twice a Day, in the Treatment of Outpatients With Perennial Allergic Rhinitis
The aim of this trial is to evaluate the clinical efficacy and safety of Epinastine 10 mg + Pseudoephedrine 120 mg slow release (SR) administered twice a day, compared to Epinastine 10 mg alone administered twice daily.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Epinastine, Pseudoephedrine, Placebo
- 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.
EpinastineDrug
PseudoephedrineDrug
PlaceboDrug
Placebo during run-in period
| Study group | Role | What they receive |
|---|---|---|
| Epinastine + Pseudoephedrine | Experimental | Not described Receives: Drug: Epinastine; Drug: Pseudoephedrine; Drug: Placebo |
| Epinastine | Experimental | Not described Receives: Drug: Epinastine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of severity of nasal blockage by Visual Analog Scale (VAS)
Measured: at the end of weeks 1, 2, 3, 4
Incidence of laboratory alterations
Measured: day 14, 28 and 35
Incidence of premature discontinuations of the study due to adverse events
Measured: up to 4 weeks
Incidence and severity of all adverse events
Measured: up to 5 weeks
Secondary outcomes (11)
Daily evaluation of the nasal blockage by the patient
Measured: daily up to 4 weeks
Classification of the severity of the symptoms by the investigator
Measured: at the end of weeks 1, 2, 3, 4
Changes in nasal physical examination
Measured: Baseline and at the end of weeks 1, 2, 3, 4
Changes in rhinorrhea symptoms evaluated by investigator
Measured: Baseline and at the end of weeks 1, 2, 3, 4
Changes in pruritus symptoms evaluated by investigator
Measured: Baseline and at the end of weeks 1, 2, 3, 4
Changes in sneezing symptoms evaluated by investigator
Measured: Baseline and at the end of weeks 1, 2, 3, 4
Changes in lacrimation symptoms evaluated by investigator
Measured: Baseline and at the end of weeks 1, 2, 3, 4
Changes in rhinorrhea symptoms evaluated by patient using VAS
Measured: Baseline and at the end of weeks 1, 2, 3, 4
Changes in pruritus symptoms evaluated by patient using VAS
Measured: Baseline and at the end of weeks 1, 2, 3, 4
Changes in sneezing symptoms evaluated by patient using VAS
Measured: Baseline and at the end of weeks 1, 2, 3, 4
Changes in lacrimation symptoms evaluated by patient using VAS
Measured: Baseline and at the end of weeks 1, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 2000
- Primary completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182518
- Sponsor's protocol ID
- 262.254
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Parallel Trial to Evaluate the Clinical Efficacy and Safety of Epinastine 10 mg + Pseudoephedrine 120 mg SR, Twice a Day, Versus Epinastine 10 mg Alone, Twice a Day, in the Treatment of Outpatients With Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02182518
- Acronym / sponsor ID
- 262.254
- Conditions
- Rhinitis, Allergic, Perennial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Jul 2001 (actual)
- First posted
- 8 Jul 2014 (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 aim of this trial is to evaluate the clinical efficacy and safety of Epinastine 10 mg + Pseudoephedrine 120 mg slow release (SR) administered twice a day, compared to Epinastine 10 mg alone administered twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epinastine + Pseudoephedrine | Experimental | Drug: Epinastine, Drug: Pseudoephedrine, Drug: Placebo |
| Epinastine | Experimental | Drug: Epinastine, Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Male and female outpatients
- Over 12 years old
- Patients who have granted their written informed consent, personally or by a legal representative, to be part of the study and in accomplishment of the model of informed consent approved by the Ethic Committee of the institution
- Patients with an established diagnosis of allergic perennial rhinitis under the clinical criteria (allergic to one or more allergens)
- Patients with moderate or complete nasal blockage characterizes by ≥50 mm in the VAS for this parameter during visits 1 and 2
Key exclusion criteria (66 listed)
- Pregnant or breast feeding women, or women without contraceptive method who:
- Patients unable to understand, accept or follow the protocol instructions
- History of serious adverse events with antihistamines
- Patients under treatment with calcium antagonists or other antihypertensive drugs
- Patients under treatment with digitalis
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 |
|---|---|---|
| Epinastine | Drug | Epinastine, Epinastine + Pseudoephedrine |
| Pseudoephedrine | Drug | Epinastine + Pseudoephedrine |
| PlaceboPlacebo during run-in period | Drug | Epinastine, Epinastine + Pseudoephedrine |
Primary outcome
Classification of severity of nasal blockage by Visual Analog Scale (VAS)
Time frame: at the end of weeks 1, 2, 3, 4
Incidence of laboratory alterations
Time frame: day 14, 28 and 35
Incidence of premature discontinuations of the study due to adverse events
Time frame: up to 4 weeks
Incidence and severity of all adverse events
Time frame: up to 5 weeks
11 secondary outcomes
Daily evaluation of the nasal blockage by the patient
Time frame: daily up to 4 weeks
Classification of the severity of the symptoms by the investigator
Time frame: at the end of weeks 1, 2, 3, 4
Changes in nasal physical examination
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in rhinorrhea symptoms evaluated by investigator
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in pruritus symptoms evaluated by investigator
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in sneezing symptoms evaluated by investigator
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in lacrimation symptoms evaluated by investigator
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in rhinorrhea symptoms evaluated by patient using VAS
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in pruritus symptoms evaluated by patient using VAS
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in sneezing symptoms evaluated by patient using VAS
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
Changes in lacrimation symptoms evaluated by patient using VAS
Time frame: Baseline and at the end of weeks 1, 2, 3, 4
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 14 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epinastine and Pseudoephedrine in people with Rhinitis, Allergic, Perennial, run by Boehringer Ingelheim.
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 15 inclusion and 66 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 14 Jul 2014. 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 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?
Classification of severity of nasal blockage by Visual Analog Scale (VAS) (time frame: at the end of weeks 1, 2, 3, 4). The study lists 4 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 14 Jul 2014.