Clinical Study, Non Inferiority Between Noex® 50µg Versus... | NCT02988778

Studies
Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis

NCT02988778

Sponsor

Eurofarma Laboratorios S.A.

Status

Withdrawn

Last Update Posted

Oct 9, 2019Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Rhinitis, Allergic, Perennial

Interventions

Budesonid 50mcg (Noex)
Budesonid 50mcg (Busonid)

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

regulatory strategy

Expanded Access Info

Start Date

Oct 8, 2019Actual

Primary Completion Date

Oct 8, 2019Actual

Completion Date

Oct 8, 2019Actual

First Submitted Date

Nov 28, 2016

First Submission Date that Met QC Criteria

Dec 8, 2016

First Posted Date

Dec 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2019

Last Update Posted Date

Oct 9, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to evaluate non inferiority of Eurofarma budesonide nasal spray 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 persistent rhinitis moderate to severe in sites located locally in Brazil.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Budesonid 50mcg (Noex)	Experimental	Budesonid 50mcg (Noex), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days.	Drug: Budesonid 50mcg (Noex)
Budesonid 50mcg (Busonid)	Active Comparator	Budesonid 50mcg (Busonid), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days.	Drug: Budesonid 50mcg (Busonid)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Budesonid 50mcg (Noex)	Drug	Suspention to nasal use, 2 atomization in each nostril during the morning and at night.	Budesonid 50mcg (Noex)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS)	Using the questionnaire Nasal Index Score (NIS)	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 12
History of allergic persistent rhinitis moderate to severe at least 2 years
Proved allergic using PRICK or RAST test
Nasal symptoms (NIS) > 3 and nasal obstruction >1
Indication of nasal corticosteroids use
Washout of nasal corticosteroids for 14 days
ICF

Exclusion Criteria:

Other types of rhinitis
Asthma non controlled
Use of oral/injectable corticoids 30 days before screening
patients not eligible to complete diaries
patients with allergy to any substance of medicines
non controlled disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mauro Acir Crippa Junior, MD	Allergisa Pesquisa Dermato-Cosmetica LTDA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandra Dumont		Campinas			Brazil

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Undecided, but could be shared upon investigator's request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012221	Rhinitis, Allergic, Perennial

Ancestor Terms

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided