Nasal Congestion and InflammationsPhase 3NCT01393561
Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
A Phase 3 study testing Group 1 and Group 2 in people with Nasal Congestion and Inflammations and Rhinitis, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 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 12 years and older
- Conditions the study is for
- Nasal Congestion and Inflammations, Rhinitis
- What is being tested?
- Group 1 and Group 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2014
- 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
- Patients over 12 years old, of both sexes, remaining the feasibility of a legal representant according to need, able to understand and provide ICF and able to allow compliance to treatment and the requirements of the protocol, according to age group;
- 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 under 12 years old or weight less than 40kg;
- 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, according to age group;
- 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.
About this study
Official title: Multicenter Clinical Trial, Phase III, Randomized, Double-blind, Placebo Controlled, Comparative for Evaluate the Efficacy and Safety of Fixed Dose Combination of Brompheniramine Maleate + Phenylephrine Chlorhydrate for the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis (Common Cold) and Allergic Reactions, in Patients Over 12 Years Old
This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 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. The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
- Conditions
- Nasal Congestion and Inflammations, Rhinitis
- Being tested
- Group 1, Group 2
- 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.
Group 1Drug
Brompheniramine + phenylephrine
Group 2Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Fixed dose combination of brompheniramine + phenylephrine. Receives: Drug: Group 1 |
| Group 2 | Placebo comparator | Placebo Receives: Drug: Group 2 |
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.
- First posted13 Jul 2011 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionDec 2014
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fábio M Castro, Principal investigator, IMA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393561
- Sponsor's protocol ID
- ACH-DCN-03(04/10)
- Status last verified
- Oct 2016
- First submitted
- 27 Oct 2010
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trial, Phase III, Randomized, Double-blind, Placebo Controlled, Comparative for Evaluate the Efficacy and Safety of Fixed Dose Combination of Brompheniramine Maleate + Phenylephrine Chlorhydrate for the Treatment of Nasal Congestion and Runny Nose Present in Acute Crisis of Viral Rhinitis (Common Cold) and Allergic Reactions, in Patients Over 12 Years Old
- ClinicalTrials.gov ID
- NCT01393561
- Acronym / sponsor ID
- ACH-DCN-03(04/10)
- Conditions
- Nasal Congestion and Inflammations, Rhinitis
- Keywords
- Rhinitis, Common cold, Nasal symptoms, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (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.
This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 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. The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Group 1Fixed dose combination of brompheniramine + phenylephrine. |
| Group 2 | Placebo comparator | Drug: Group 2Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 12 years old, of both sexes, remaining the feasibility of a legal representant according to need, able to understand and provide ICF and able to allow compliance to treatment and the requirements of the protocol, according to age group;
- 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 under 12 years old or weight less than 40kg;
- 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 |
|---|---|---|
| Group 1Brompheniramine + phenylephrine | Drug | Group 1 |
| Group 2Placebo | Drug | Group 2 |
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 31 Oct 2016.
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
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group 1 and Group 2 in people with Nasal Congestion and Inflammations and Rhinitis, run by Ache Laboratorios Farmaceuticos S.A..
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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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 31 Oct 2016.