Allergic RhinitisPhase 3NOEXNCT01022047
Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis
A Phase 3 study testing Noex and Budecort Aqua in people with Allergic Rhinitis, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Noex and Budecort Aqua
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Dec 2010
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Sign the informed consent form or - in case of patients younger than 18 years, the legal responsible must sign the consent;
- ≥ 12 years old;
- NIS scale score > 4 points at the randomization visit
- Patients with persistent mild to moderate AR, according to the ARIA criteria (see Appendix B), with indication for use budesonide;
- Positive skin test for at least one relevant airborne agent;
- AR symptoms for at least 2 years;
- May undergo a washout period of at least 2 weeks (without using any oral, nasal or inhalant corticosteroid agent; see 6.4).
Who cannot join
- Patients with persistent severe allergic rhinitis;
- Patients with severe co-morbidities (at the investigator's opinion);
- Patients with moderate to severe persistent asthma;
- Clinical history of infection of the airways 30 days before the study entry;
- Patients with structural changes causing nasal obstruction, such as pronounced nasal septum deviation, nasal polyps or any other type of nasal malformation;
- Pregnant women and patients planning to become pregnant during the study period or breastfeeding women;
- Patients in need of other drugs to treat the allergic rhinitis, such as anti-immunoglobulin E, allergen-specific immunotherapy, anti-leukotrienes, systemic vasoconstrictors, oral corticosteroids and other inhalant corticosteroids.
- Patients using allergen-specific immunotherapy during the last year, as well as using anti-leukotrienes and anti-immunoglobulin E during the last month, or even patients using inhalant or oral corticosteroids after V0 will not be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo
About this study
Official title: A Phase III, Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis in a Test Group Treated With Noex 32 mcg and a Reference Group Treated With Budecort Aqua® 32 mcg
To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.
Read the detailed description
Primary objective: To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.
Secondary objectives: To determine the total NIS scale score after 12 weeks of treatment and the scores of the same scale individually for the symptoms of nasal obstruction, coryza, sneezing and nasal pruritus after 4 and 12 weeks of treatment, as well as to assess the safety of the study product according to the presence of adverse events.
Some eligibility criteria:
- NIS scale score > 4 points at the randomization visit
- Patients with persistent mild to moderate AR, according to the ARIA criteria with indication for use budesonide;
- Conditions
- Allergic Rhinitis
- Being tested
- Noex, Budecort Aqua
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoexDrug
The patients shall use the Noex drug only once a day (one application in each nostril) during the 12 weeks of treatment
Budecort AquaDrug
The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Noex | Experimental | The patients shall use the NOEX drug only once a day (one application in each nostril) during the 12 weeks of treatment Receives: Drug: Noex |
| Budecort Aqua | Active comparator | The patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment. Receives: Drug: Budecort Aqua |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to evaluate the efficiency of Noex
Measured: 5 months
Secondary outcomes (1)
The secondary objectives and endpoints of the study are to evaluate the safety of Noex®, according to the frequency of the adverse events.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionFeb 2010
- Study completionDec 2010
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.
- 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
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fabio Morato, M.D., Principal investigator, IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022047
- Sponsor's protocol ID
- EF096
- Acronym
- NOEX
- Status last verified
- Dec 2010
- First submitted
- 30 Nov 2009
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis in a Test Group Treated With Noex 32 mcg and a Reference Group Treated With Budecort Aqua® 32 mcg
- ClinicalTrials.gov ID
- NCT01022047
- Acronym / sponsor ID
- NOEX / EF096
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Dec 2009 (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.
To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.
Detailed description
Primary objective: To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.
Secondary objectives: To determine the total NIS scale score after 12 weeks of treatment and the scores of the same scale individually for the symptoms of nasal obstruction, coryza, sneezing and nasal pruritus after 4 and 12 weeks of treatment, as well as to assess the safety of the study product according to the presence of adverse events.
Some eligibility criteria:
- NIS scale score > 4 points at the randomization visit
- Patients with persistent mild to moderate AR, according to the ARIA criteria with indication for use budesonide;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noex | Experimental | Drug: NoexThe patients shall use the NOEX drug only once a day (one application in each nostril) during the 12 weeks of treatment |
| Budecort Aqua | Active comparator | Drug: Budecort AquaThe patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Sign the informed consent form or - in case of patients younger than 18 years, the legal responsible must sign the consent;
- ≥ 12 years old;
- NIS scale score > 4 points at the randomization visit
- Patients with persistent mild to moderate AR, according to the ARIA criteria (see Appendix B), with indication for use budesonide;
- Positive skin test for at least one relevant airborne agent;
Key exclusion criteria (8 listed)
- Patients with persistent severe allergic rhinitis;
- Patients with severe co-morbidities (at the investigator's opinion);
- Patients with moderate to severe persistent asthma;
- Clinical history of infection of the airways 30 days before the study entry;
- Patients with structural changes causing nasal obstruction, such as pronounced nasal septum deviation, nasal polyps or any other type of nasal malformation;
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 |
|---|---|---|
| NoexThe patients shall use the Noex drug only once a day (one application in each nostril) during the 12 weeks of treatment | Drug | Noex |
| Budecort AquaThe patients shall use the Budecort Aqua drug only once a day (one application in each nostril) during the 12 weeks of treatment. | Drug | Budecort Aqua |
Primary outcome
The primary objective of the study is to evaluate the efficiency of Noex
Time frame: 5 months
1 secondary outcome
The secondary objectives and endpoints of the study are to evaluate the safety of Noex®, according to the frequency of the adverse events.
Time frame: 5 months
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 27 Jul 2015.
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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.
Fabio Morato, M.D. principal investigator
IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
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 Noex and Budecort Aqua in people with Allergic Rhinitis, run by Eurofarma Laboratorios S.A. 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 7 inclusion and 8 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 27 Jul 2015. 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?
The primary objective of the study is to evaluate the efficiency of Noex (time frame: 5 months). 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 27 Jul 2015.