Perennial Allergic RhinitisPhase 3NCT01228630
Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis.
A Phase 3 study testing Cloratadd-D and Allegra-D in people with Perennial Allergic Rhinitis, run by Azidus Brasil at 1 site in Brazil.
Trial summary
The loratadine-pseudoephedrine combination has proven to be more effective than the use of these individual components. This prospective, randomized, double-blind and paralel study, in which patients with perennial allergic rhinitis receive one of loratadine + pseudoephedrine association drug for treatment of signs… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Cloratadd-D and Allegra-D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to May 2012
- 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
- Comply with all the purposes and procedures of the study by signing and dating the IC own free will. In the case of minors, the document should be signed and dated by the parent or legal guardian;
- Have age over 12 years, regardless of gender, ethnicity or social class;
- Present clinical status of perennial allergic rhinitis from mild to moderate;
- Present clinical status with at least 12 months of evolution;
- Submit the examination of IgE elevation (above 100KU / L).
Who cannot join
- Have participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
- Pregnant or lactating women;
- Have made use of:
- Intranasal or systemic corticosteroids in the month before inclusion;
- Intranasal cromolyn in the two weeks preceding inclusion;
- Intranasal or systemic decongestants in the 03 days preceding inclusion;
Show all 19Show fewer
- Intranasal antihistamines or systemic in the 03 days preceding the survey;
- Loratadine in the 10 days preceding the survey.
- have any disease or anatomical abnormality in the upper airways which could jeopardize the analysis of data, for example, tumors or severe septal deviations;
- History of smoking in the 03 months preceding the inclusion;
- History of alcohol or illicit drugs;
- History of liver disease or kidney disease;
- Electric current asthma or gift last year;
- Table of uncontrolled hypertension;
- Patients with heart disease or who use drugs for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;
- Patients with flu-like symptoms or fever of unknown origin, defined current or within last 07 days;
- Clinical diagnosis of rhinitis is not that kind of allergic and perennial;
- Be patient with sensitivity to loratadine, pseudoephedrine sulfate, or any components of the formula;
- Estimated travel or displacement of the southeast for more than 50% of monitoring.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Lal Clínica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270-245
About this study
Official title: Randomized Clinical Study for Efficacy Assessment Between Cloratadd-D, Loratadine + Pseudoephedrine (Coated Pill), Produced by EMS S/A Laboratories and Allegra-D , Produced by Sanofi-Aventis for Patients With Perennial Allergic Rhinitis.
The loratadine-pseudoephedrine combination has proven to be more effective than the use of these individual components. This prospective, randomized, double-blind and paralel study, in which patients with perennial allergic rhinitis receive one of loratadine + pseudoephedrine association drug for treatment of signs and symptoms during 4 weeks.
Read the detailed description
The effectiveness of treatment in each drug group will be evaluate by global improvement of signs (nasal mucous edema, ocular hyperemia, nasal secretion) and symptoms (itching eye, tearing,itching nose, itching on the palate) of perennial allergic rhinitis, after 4 weeks of treatment. Symptoms as rhinorrhea, nasal congestion, itching nose, sneezing and itching eye were considered as secondary efficacy endpoint, along with the questionnaire of quality of life SF-36. Safety evaluation data will include report of all adverse events (including type, frequency, instensity, seriousness, severity and action taken related to investigational product) reported by patients, parents or legal responsible, ou observed by Investigator.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Cloratadd-D, Allegra-D
- Keywords
- rhinitis, loratadine, coated pill
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cloratadd-DDrug
Also called Loratadine + pseudoephedrine
The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.
Allegra-DDrug
Also called Loratadine + pseudoephedrine
The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.
| Study group | Role | What they receive |
|---|---|---|
| Cloratadd-D | Experimental | Loratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to comparator drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water. Receives: Drug: Cloratadd-D |
| Allegra-D | Active comparator | Loratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to test drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water. Receives: Drug: Allegra-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs and symptoms evaluated by a PHYSICIAN
Signs of swelling of nasal mucosa,ocular hyperemia and nasal discharge. Symptoms of itchy eyes, watery eyes,itchy nose and itching of the palate. These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days.
Measured: 28 days of treatment.
Secondary outcomes (1)
Symptoms reported by PATIENTS
Symptoms of runny nose,nasal congestion, itchy nose, sneezing, quality of life.These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days.
Measured: 28 days of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EMS S/A
- Responsible party
- Sponsor
- Investigators
- Luiz Tikara Shimizu, PI, Principal investigator, LAL Clinica Pesquisa e Desenvolvimento Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228630
- Sponsor's protocol ID
- LOREMS0810
- Status last verified
- Apr 2016
- First submitted
- 18 Oct 2010
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: It believed that after the data analysis and presentation to the IRC, all data will become public.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study for Efficacy Assessment Between Cloratadd-D, Loratadine + Pseudoephedrine (Coated Pill), Produced by EMS S/A Laboratories and Allegra-D , Produced by Sanofi-Aventis for Patients With Perennial Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT01228630
- Acronym / sponsor ID
- LOREMS0810
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- rhinitis, loratadine, coated pill
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Collaborators
- EMS S/A
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Oct 2010 (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 loratadine-pseudoephedrine combination has proven to be more effective than the use of these individual components. This prospective, randomized, double-blind and paralel study, in which patients with perennial allergic rhinitis receive one of loratadine + pseudoephedrine association drug for treatment of signs and symptoms during 4 weeks.
Detailed description
The effectiveness of treatment in each drug group will be evaluate by global improvement of signs (nasal mucous edema, ocular hyperemia, nasal secretion) and symptoms (itching eye, tearing,itching nose, itching on the palate) of perennial allergic rhinitis, after 4 weeks of treatment. Symptoms as rhinorrhea, nasal congestion, itching nose, sneezing and itching eye were considered as secondary efficacy endpoint, along with the questionnaire of quality of life SF-36. Safety evaluation data will include report of all adverse events (including type, frequency, instensity, seriousness, severity and action taken related to investigational product) reported by patients, parents or legal responsible, ou observed by Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cloratadd-D | Experimental | Drug: Cloratadd-DLoratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to comparator drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water. |
| Allegra-D | Active comparator | Drug: Allegra-DLoratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to test drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Comply with all the purposes and procedures of the study by signing and dating the IC own free will. In the case of minors, the document should be signed and dated by the parent or legal guardian;
- Have age over 12 years, regardless of gender, ethnicity or social class;
- Present clinical status of perennial allergic rhinitis from mild to moderate;
- Present clinical status with at least 12 months of evolution;
- Submit the examination of IgE elevation (above 100KU / L).
Key exclusion criteria (19 listed)
- Have participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
- Pregnant or lactating women;
- Have made use of:
- have any disease or anatomical abnormality in the upper airways which could jeopardize the analysis of data, for example, tumors or severe septal deviations;
- History of smoking in the 03 months preceding the inclusion;
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 |
|---|---|---|
| Cloratadd-DAlso: Loratadine + pseudoephedrineThe patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water. | Drug | Cloratadd-D |
| Allegra-DAlso: Loratadine + pseudoephedrineThe patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water. | Drug | Allegra-D |
Primary outcome
Signs and symptoms evaluated by a PHYSICIAN
Time frame: 28 days of treatment.
Signs of swelling of nasal mucosa,ocular hyperemia and nasal discharge. Symptoms of itchy eyes, watery eyes,itchy nose and itching of the palate. These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days.
1 secondary outcome
Symptoms reported by PATIENTS
Time frame: 28 days of treatment.
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 Apr 2016.
- Individual participant dataSharing planned: Undecided. It believed that after the data analysis and presentation to the IRC, all data will become public.
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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.
Luiz Tikara Shimizu, PI principal investigator
LAL Clinica Pesquisa e Desenvolvimento Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cloratadd-D and Allegra-D in people with Perennial Allergic Rhinitis, run by Azidus Brasil at 1 site in Brazil.
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 5 inclusion and 19 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 Apr 2016. 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 Brazil. 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 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?
Signs and symptoms evaluated by a PHYSICIAN (time frame: 28 days of treatment.). 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 Apr 2016.