FluPhase 3NCT01533220
Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
A Phase 3 study testing naphazoline hydrocloride and Naphazoline hydrocloride + Pheniramine Maleate + Panthenol in people with Flu and Cold, run by EMS.
Trial summary
The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flu, Cold, Allergic Disorder of Respiratory System
- What is being tested?
- naphazoline hydrocloride and Naphazoline hydrocloride + Pheniramine Maleate + Panthenol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be able to understand the study procedures, agree to participate and give written consent.
- Patients aged over 18 years of both sexes;
- Patients with clinical signs of flu and colds or other upper respiratory allergies;
- Patients with early signs and symptoms with time of evolution not more than 72 hours.
Who cannot join
- Patients treated with antibiotics
- Current treatment with immunosuppressants (eg.cyclosporine or methotrexate);
- Use of intranasal cromalin the week before inclusion;
- Use of decongestants or anti-histaminic (intranasal or systemic);
- Presence of any disease or anatomical abnormality that may difficult the data analysis ;
- Uncontrolled hypertension;
Show all 10Show fewer
- Presence of respiratory symptoms for more than 14 days;
- History of abuse of drugs and alcohol;
- Presence of other concomitant pulmonary diseases;
- Hypersensitivity to any compound of investigational product
About this study
Official title: A Randomized, Double-blind, Prospective, Multicentric, Superior Efficacy and Safety of Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal Due to Colds or Other Upper Respiratory Allergies
The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment.
The study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.
Read the detailed description
STUDY DESIGN
- randomized,double blind, prospective, multicentric, parallel group, intent to treat trial
- Experiment duration: 3 days
- 2 visits (days 0 and 2)
- Evaluation of symptoms reduction
- Adverse events evaluation
- Conditions
- Flu, Cold, Allergic Disorder of Respiratory System
- Being tested
- naphazoline hydrocloride, Naphazoline hydrocloride + Pheniramine Maleate + Panthenol
- Keywords
- nasal and nasopharyngeal congestion
- Medical subject headings
- Influenza, Human, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naphazoline hydroclorideDrug
02 drops into each nostril, 04 times a day for 03 days
Naphazoline hydrocloride + Pheniramine Maleate + PanthenolDrug
02 drops into each nostril each 12 hours for 03 days
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg).
02 drops in each nostril every 12 hours for 3 days Receives: Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol |
| Comparator group | Active comparator | Naphazoline Hydrocloride (0.5mg)
02 drops in each nostril every 12 hours for 3 days Receives: Drug: naphazoline hydrocloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay
The individual response rate to the nasal congestion reduction is calculated by measuring the peak flow nasal inspiratory (PFNI) during the first and last visit.
Measured: 3 days
Secondary outcomes (1)
Safety will be evaluated by the Adverse events occurence
Adverse events will be collected and followed in order to evaluate safety and tolerability
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study start1 Jan 2013
- Primary completion31 Aug 2013
- Study completion30 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FluStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533220
- Sponsor's protocol ID
- NMPEMS1011
- Status last verified
- Jan 2019
- First submitted
- 9 Feb 2012
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Prospective, Multicentric, Superior Efficacy and Safety of Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal Due to Colds or Other Upper Respiratory Allergies
- ClinicalTrials.gov ID
- NCT01533220
- Acronym / sponsor ID
- NMPEMS1011
- Conditions
- Flu, Cold, Allergic Disorder of Respiratory System
- Keywords
- nasal and nasopharyngeal congestion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Aug 2013 (actual)
- Study completion
- 30 Apr 2014 (actual)
- First posted
- 15 Feb 2012 (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 common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment.
The study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.
Detailed description
STUDY DESIGN
- randomized,double blind, prospective, multicentric, parallel group, intent to treat trial
- Experiment duration: 3 days
- 2 visits (days 0 and 2)
- Evaluation of symptoms reduction
- Adverse events evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Drug: Naphazoline hydrocloride + Pheniramine Maleate + PanthenolNaphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg). 02 drops in each nostril every 12 hours for 3 days |
| Comparator group | Active comparator | Drug: naphazoline hydroclorideNaphazoline Hydrocloride (0.5mg) 02 drops in each nostril every 12 hours for 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be able to understand the study procedures, agree to participate and give written consent.
- Patients aged over 18 years of both sexes;
- Patients with clinical signs of flu and colds or other upper respiratory allergies;
- Patients with early signs and symptoms with time of evolution not more than 72 hours.
Key exclusion criteria (10 listed)
- Patients treated with antibiotics
- Current treatment with immunosuppressants (eg.cyclosporine or methotrexate);
- Use of intranasal cromalin the week before inclusion;
- Use of decongestants or anti-histaminic (intranasal or systemic);
- Presence of any disease or anatomical abnormality that may difficult the data analysis ;
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 |
|---|---|---|
| naphazoline hydrocloride02 drops into each nostril, 04 times a day for 03 days | Drug | Comparator group |
| Naphazoline hydrocloride + Pheniramine Maleate + Panthenol02 drops into each nostril each 12 hours for 03 days | Drug | Test group |
Primary outcome
Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay
Time frame: 3 days
The individual response rate to the nasal congestion reduction is calculated by measuring the peak flow nasal inspiratory (PFNI) during the first and last visit.
1 secondary outcome
Safety will be evaluated by the Adverse events occurence
Time frame: 3 days
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 25 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing naphazoline hydrocloride and Naphazoline hydrocloride + Pheniramine Maleate + Panthenol in people with Flu and Cold, run by EMS.
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 10 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 25 Jan 2019. 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. 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?
Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay (time frame: 3 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 25 Jan 2019.