Rhinitis, Allergic, PerennialPhase 3RINEX32NCT02972866
Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis
A Phase 3 study testing Budesonide in people with Rhinitis, Allergic, Perennial, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group. Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Nov 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 12.
- History of alergic persistent rhinitis moderate to severe at least 2 years.
- Proved alergic using PRICK or RAST test.
- Nasal symptoms (NIS) > 3 and nasal obstruction >1.
- Indication of nasal corticorteroids use..
- Washout of nasal corticorteroids for 14 days.
- ICF.
Who cannot join
- Other types of rhinitis;
- Asthma non controled
- Use of oral/injectable corticoids 30 days before screening.
- patients not eligible to complete diaries.
- patients with alergy to any substance of medicines.
- non controlled desease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III, Multicenter, Randomized, Simple-blinded, Paralel Groups to Evaluate Non Inferiority of Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Persistent Rhinitis Moderate to Severe
This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.
Read the detailed description
Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority.
This study was draw to treat patients with persisntent rhinits moderate to severe in sites localted locally in Brasil.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Budesonide
- 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.
BudesonideDrug
Also called Noex 32mcg, Budecort Aqua 32mcg
Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
| Study group | Role | What they receive |
|---|---|---|
| Noex 32mcg | Experimental | Noex/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day.
Tretament of 28 days. Receives: Drug: Budesonide |
| Budecort Aqua 32 mcg | Experimental | Budecort Aqua/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day.
Tretament of 28 days. Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.
The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startJun 2016 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Why it stopped: Regulatory strategy
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.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mauro Acir Crippa Junior, Principal investigator, Allergisa Pesquisa Dermato-Cosmética Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972866
- Sponsor's protocol ID
- EF148
- Acronym
- RINEX32
- Status last verified
- Oct 2018
- First submitted
- 11 Nov 2016
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided, but could be shared upon investigator's request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicenter, Randomized, Simple-blinded, Paralel Groups to Evaluate Non Inferiority of Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Persistent Rhinitis Moderate to Severe
- ClinicalTrials.gov ID
- NCT02972866
- Acronym / sponsor ID
- RINEX32 / EF148
- Conditions
- Rhinitis, Allergic, Perennial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Regulatory strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 25 Nov 2016 (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 study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.
Detailed description
Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority.
This study was draw to treat patients with persisntent rhinits moderate to severe in sites localted locally in Brasil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noex 32mcg | Experimental | Drug: BudesonideNoex/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day. Tretament of 28 days. |
| Budecort Aqua 32 mcg | Experimental | Drug: BudesonideBudecort Aqua/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day. Tretament of 28 days. |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 12.
- History of alergic persistent rhinitis moderate to severe at least 2 years.
- Proved alergic using PRICK or RAST test.
- Nasal symptoms (NIS) > 3 and nasal obstruction >1.
- Indication of nasal corticorteroids use..
Key exclusion criteria (6 listed)
- Other types of rhinitis;
- Asthma non controled
- Use of oral/injectable corticoids 30 days before screening.
- patients not eligible to complete diaries.
- patients with alergy to any substance of medicines.
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 |
|---|---|---|
| BudesonideAlso: Noex 32mcg, Budecort Aqua 32mcgSuspention to nasal use, 2 atomization in each nostril during the morning and at night. | Drug | Budecort Aqua 32 mcg, Noex 32mcg |
Primary outcome
Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.
Time frame: 28 days
The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Individual participant dataSharing planned: Undecided. Undecided, but could be shared upon investigator's request.
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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.
Mauro Acir Crippa Junior principal investigator
Allergisa Pesquisa Dermato-Cosmética 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 Budesonide in people with Rhinitis, Allergic, Perennial, 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 6 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: withdrawn, as of the sponsor's last update on 9 Oct 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment. (time frame: 28 days). 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 9 Oct 2019.