Nasal Congestion and InflammationsPhase 3NCT01393548

Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis

A Phase 3 study testing brompheniramine + phenylephrine and Brompheniramine + pseudoephedrine in people with Nasal Congestion and Inflammations and Rhinitis, run by Ache Laboratorios Farmaceuticos 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

This is a multicenter clinical trial, phase III, non-inferiority, controlled by active medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and a maximum of 48 hours prior to inclusion. Read more about this study

Who is it for?: Ages 2 to 12 years
Conditions the study is for: Nasal Congestion and Inflammations, Rhinitis
What is being tested?: brompheniramine + phenylephrine and Brompheniramine + pseudoephedrine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 879 participants
Where: 1 siteBrazil
Study dates: Aug 2014to Dec 2016
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 2 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients between 2 and 12 years old, of both sexes. Must be responsible be able to understand and provide ICF and able to allow compliance to treatment and protocol requirements, fulfilling the regular visits;
Patients with symptoms of acute inflammation upper airway, starting between 24 and 48 hours of their inclusion in this study protocol;
Presence of runny nose classification moderate or severe (score 2 or 3), according the responsible evaluation;
Presence of nasal congestion classification moderate or severe (score 2 or 3), according the responsible evaluation.

Who cannot join

Patients younger than 2 years or percentile for body weight and/or height less than 25;
History of nasal obstruction in chronic rhinosinusitis and / or nasal polyposis;
Oral chronic respirator with history for six months;
Personal history of nasal surgery that in the opinion of the investigator can influence the resistance to nasal airflow;
Patients who have a clinical history confirmed (diagnosed) with asthma;
Patients under medicine treatment for chronic allergy;

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Patients with gastroesophageal reflux disease;
Presence of psychiatric illness of any kind;
Presence of mental retardation from any cause;
Diagnosis of renal or hepatic failure;
Patients with genetic syndromes;
History of hypersensitivity to (s) drug (s) of study or their excipients;
Use of prohibited medicine within the prescribed period before the V0 - Inclusion Visit (Table 1);
Patients who participated in the last 12 months, of clinical trials protocols;
Patients who didn´t updated vaccine book;
Relatives of sponsor´s or study site´s employee;
Suggestive signs of bacterial infection of upper airways at rhinoscopy, otoscopy or oroscopy;
Presence of anemic/inflamed turbinate at anterior rhinoscopy;
Presence of septal deviation grade II and III (in any region and any nasal cavity) and / or nasal polyps, or other conditions determinants of nasal obstruction;
Presence of purulent or mucopurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation;
Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the patient or interfere with the endpoints of study.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Ache Laboratorios Farmaceuticos
Guarulhos, São Paulo

Other trials in Brazil

About this study

Official title: Multicenter, Phase III, Randomized, Open, Parallel, Comparative to Evaluate the Efficacy and Safety of the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis and Allergic Reactions, in Pediatric Patients

Read the detailed description

This study evaluate the efficacy and safety of experimental drug The study was designed to evaluate the efficacy and safety of fixed combinations Decongex® Plus Syrup and Decongex® Plus Oral Solution (consisting of brompheniramine maleate and phenylephrine hydrochloride) compared to Resfenol® Oral Solution (paracetamol, maleate chlorpheniramine and phenylephrine hydrochloride) in the treatment of nasal congestion and rhinorrhea present in acute attacks of viral rhinitis (common cold) and allergic. This study population will consist in participants of both sexes, aged between 6 to 11 years old with acute inflammatory condition of the upper airways, defined as nasal congestion and runny nose, with no less than 24 (twenty four) hours and a maximum of 48 (forty-eight) hours prior to inclusion.

Conditions: Nasal Congestion and Inflammations, Rhinitis
Being tested: brompheniramine + phenylephrine, Brompheniramine + pseudoephedrine
Keywords: Rhinitis, common cold, nasal symptoms, children
Medical subject headings: Nasal Obstruction, Inflammation, Rhinitis, Common Cold

What participants receive

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

brompheniramine + phenylephrineDrug
Also called Group 1
Oral solution: brompheniramine (2mg/mL) and phenylephrine (2,5 mg/mL), t.i.d., according weight of patient.
OR Syrup: brompheniramine (2mg/5mL) and phenylephrine(5 mg/5mL), t.i.d., according weight of patient.
Brompheniramine + pseudoephedrineDrug
Also called Group 2
Elixir: Brompheniramine (0,2mg/mL) and pseudoephedrine (3,0 mg/mL), t.i.d., according weight of patient

Study groups in NCT01393548
Study group	Role	What they receive
brompheniramine + phenylephrine	Experimental	Fixed dose combination of brompheniramine + phenylephrine Receives: Drug: brompheniramine + phenylephrine
brompheniramine + pseudoephedrine	Active comparator	Fixed dose combination of brompheniramine + pseudoephedrine Receives: Drug: Brompheniramine + pseudoephedrine

What is being measured

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

Improvement of nasal congestion and runny nose, after 48 hours of treatment
Improvement is defined as a reduction of at least one point on the rating scale, in both nasal symptoms, after 48 hours of treatment.
Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.
Measured: 48 hours after single dose of double-blind treatment

Secondary outcomes (4)

Overall score of nasal and extranasal symptoms (nasal congestion, runny nose, sneezing, watery eyes and itching)
Measured: After 2 and 5 (± 1) days of treatment
Clinical score of upper airway compromise
Measured: After 2 and 5 (± 1) days of treatment
Proportion of subjects who used at least once the rescue medication
Measured: Within 2 days and the period of 5 (± 1) days of treatment
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
Collection of safety data throughout the whole study period
Measured: Will be evaluated during the 5(± 1) days of treatment

Timeline

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

Aug 2014Dec 2016

First posted13 Jul 2011 (estimated)
Study startAug 2014
Primary completionNov 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nasal Congestion and InflammationsStudies 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: 879 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01393548
Sponsor's protocol ID: ACH-DCN-03(03/10)
Status last verified: Jan 2017
First submitted: 27 Oct 2010
Last updated: 13 Jan 2017
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Phase III, Randomized, Open, Parallel, Comparative to Evaluate the Efficacy and Safety of the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis and Allergic Reactions, in Pediatric Patients
ClinicalTrials.gov ID: NCT01393548
Acronym / sponsor ID: ACH-DCN-03(03/10)
Conditions: Nasal Congestion and Inflammations, Rhinitis
Keywords: Rhinitis, common cold, nasal symptoms, children
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 879 participants (actual)
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Nov 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 13 Jul 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.

Detailed description

Study design

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

Arm	Type	Receives
brompheniramine + phenylephrine	Experimental	Drug: brompheniramine + phenylephrineFixed dose combination of brompheniramine + phenylephrine
brompheniramine + pseudoephedrine	Active comparator	Drug: Brompheniramine + pseudoephedrineFixed dose combination of brompheniramine + pseudoephedrine

Who may qualify

Ages: 2 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Patients between 2 and 12 years old, of both sexes. Must be responsible be able to understand and provide ICF and able to allow compliance to treatment and protocol requirements, fulfilling the regular visits;
Patients with symptoms of acute inflammation upper airway, starting between 24 and 48 hours of their inclusion in this study protocol;
Presence of runny nose classification moderate or severe (score 2 or 3), according the responsible evaluation;
Presence of nasal congestion classification moderate or severe (score 2 or 3), according the responsible evaluation.

Key exclusion criteria (22 listed)

Patients younger than 2 years or percentile for body weight and/or height less than 25;
History of nasal obstruction in chronic rhinosinusitis and / or nasal polyposis;
Oral chronic respirator with history for six months;
Personal history of nasal surgery that in the opinion of the investigator can influence the resistance to nasal airflow;
Patients who have a clinical history confirmed (diagnosed) with asthma;

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
brompheniramine + phenylephrineAlso: Group 1Oral solution: brompheniramine (2mg/mL) and phenylephrine (2,5 mg/mL), t.i.d., according weight of patient. OR Syrup: brompheniramine (2mg/5mL) and phenylephrine(5 mg/5mL), t.i.d., according weight of patient.	Drug	brompheniramine + phenylephrine
Brompheniramine + pseudoephedrineAlso: Group 2Elixir: Brompheniramine (0,2mg/mL) and pseudoephedrine (3,0 mg/mL), t.i.d., according weight of patient	Drug	brompheniramine + pseudoephedrine

Primary outcome

Improvement of nasal congestion and runny nose, after 48 hours of treatment
Time frame: 48 hours after single dose of double-blind treatment
Improvement is defined as a reduction of at least one point on the rating scale, in both nasal symptoms, after 48 hours of treatment. Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.

4 secondary outcomes

Overall score of nasal and extranasal symptoms (nasal congestion, runny nose, sneezing, watery eyes and itching)
Time frame: After 2 and 5 (± 1) days of treatment
Clinical score of upper airway compromise
Time frame: After 2 and 5 (± 1) days of treatment
Proportion of subjects who used at least once the rescue medication
Time frame: Within 2 days and the period of 5 (± 1) days of treatment
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
Time frame: Will be evaluated during the 5(± 1) 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 13 Jan 2017.

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.

Fábio M Castro principal investigator

IMA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 22 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 13 Jan 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?

Improvement of nasal congestion and runny nose, after 48 hours of treatment (time frame: 48 hours after single dose of double-blind treatment). 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 NCT01393548.

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 13 Jan 2017.