Mild to Moderate Persistent Allergic RhinitisPhase 3NCT01372865

A Clinical Trial About Treatment of Mild to Moderate Persistent Alergic Rhinnitis With Test or Reference Mometasone (PUMA)

A Phase 3 study testing Mometasone furoate in people with Mild to Moderate Persistent Allergic Rhinitis, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective will be to compare the impact of the study formulations on alergic rhinitis carriers. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Mild to Moderate Persistent Allergic Rhinitis
What is being tested?: Mometasone furoate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 364 participants
Where: 1 siteBrazil
Study dates: Jun 2012to Mar 2013
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

Sign and date the informed consent form or, in case of subjects younger than 18 years, the document must also be signed by a legal guardian;
≥ 12 years old;
Suffer from mild to moderated persistent alergic rhinitis;
Total NIS scale score ≥ 4 points at the screening visit and within at least 4 of the 7 days before the randomization visit;
Indication for use nasal corticosteroid;
Present with alergic rhinitis symptoms for at least 2 years;
May undergo a washout period of at least 2 weeks

Who cannot join

Patients with severe alergic rhinitis;
Patients with severe co-morbidities (at the investigator's criteria);
Patients with mild 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;
For female subjects, be pregnant or breastfeeding or planning to become pregnant or unwilling to use safe birth control methods during the study;

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subjects in need of other drugs to treat alergic rhinitis, such as anti-immunoglobulin E, immunotherapy, anti-leukotrienes, oral corticosteroids, inhalant corticosteroids, or any administration route other than cutaneous;
Active smokers (use of cigarette, pipe, cigar or any other form of tobacco in any amount within the past 3 months before the study entry);
Participation in another clinical study within the past 12 months;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo

Other trials in Brazil

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 With Eurofarma Mometasone or Reference Mometasone.

The primary objective will be to compare the impact of the study formulations on alergic rhinitis carriers.

Conditions: Mild to Moderate Persistent Allergic Rhinitis
Being tested: Mometasone furoate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mometasone furoateDrug
Mometasone furoateDrug

Study groups in NCT01372865
Study group	Role	What they receive
Mometasone	Experimental	Not described Receives: Drug: Mometasone furoate
Nasonex®	Active comparator	Not described Receives: Drug: Mometasone furoate

What is being measured

The primary outcome is the main question the study is designed to answer.

Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing
Measured: 04 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Mar 2013

First posted14 Jun 2011 (estimated)
Study startJun 2012
Primary completionFeb 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mild to Moderate Persistent 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: 364 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01372865
Sponsor's protocol ID: EF 119
Status last verified: Sep 2017
First submitted: 13 Jun 2011
Last updated: 18 Sep 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Antila MA, Castro FM, Sano F, Machado A, Fernandes F, Rosario Filho NA, Stelmach R. Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA). Braz J Otorhinolaryngol. 2016 Sep-Oct;82(5):580-8. doi: 10.1016/j.bjorl.2015.11.009. Epub 2016 Feb 15.
PubMed 26968623

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2017. 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 With Eurofarma Mometasone or Reference Mometasone.
ClinicalTrials.gov ID: NCT01372865
Acronym / sponsor ID: EF 119
Conditions: Mild to Moderate Persistent Allergic Rhinitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 364 participants (actual)
Lead sponsor: Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
Study start: Jun 2012 (actual)
Primary completion: Feb 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 14 Jun 2011 (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 primary objective will be to compare the impact of the study formulations on alergic rhinitis carriers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mometasone	Experimental	Drug: Mometasone furoate
Nasonex®	Active comparator	Drug: Mometasone furoate

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Sign and date the informed consent form or, in case of subjects younger than 18 years, the document must also be signed by a legal guardian;
≥ 12 years old;
Suffer from mild to moderated persistent alergic rhinitis;
Total NIS scale score ≥ 4 points at the screening visit and within at least 4 of the 7 days before the randomization visit;
Indication for use nasal corticosteroid;

Key exclusion criteria (9 listed)

Patients with severe alergic rhinitis;
Patients with severe co-morbidities (at the investigator's criteria);
Patients with mild 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
Mometasone furoate	Drug	Mometasone
Mometasone furoate	Drug	Nasonex®

Primary outcome

Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing
Time frame: 04 weeks

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 18 Sep 2017.
Derived from this study: PubMed 26968623Antila MA, Castro FM, Sano F, Machado A, Fernandes F, Rosario Filho NA, Stelmach R. Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA). Braz J Otorhinolaryngol. 2016 Sep-Oct;82(5):580-8. doi: 10.1016/j.bjorl.2015.11.009. Epub 2016 Feb 15.

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.

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 Mometasone furoate in people with Mild to Moderate Persistent 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 9 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 18 Sep 2017. 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?

Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing (time frame: 04 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01372865, which also lists 1 linked publication.

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 18 Sep 2017.