Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01533220
First received: February 9, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

The common cold is a major cause of nasal obstruction and reaches children and adults twice 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 treatment.

The study was designed to parallel distribution, with two equal groups, with one group will receive treatment with a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.


Condition Intervention Phase
Flu
Cold
Allergic Disorder of Respiratory System
Drug: naphazoline hydrocloride
Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Prospective, Monocentric, 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

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

    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.

    The response rate is calculated using the following formula:

    Response rate = (PFNIvi - PFNIvf) / PFNIvi

    Considering:

    • PFNIvi: PFNI in the first visit;
    • PFNIvf: PFNI at the last visit;


Secondary Outcome Measures:
  • Safety will be evaluated by the Adverse events occurence [ Time Frame: Day 5 ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability


Estimated Enrollment: 212
Study Start Date: June 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test group

Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg).

02 drops in each nostril every 12 hours for 5 days

Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol
02 drops into each nostril each 12 hours for 05 days
Active Comparator: Comparator group

Naphazoline Hydrocloride (0.5mg)

02 drops in each nostril every 12 hours for 5 days

Drug: naphazoline hydrocloride
02 drops into each nostril, 04 times a day for 05 days

Detailed Description:

STUDY DESIGN

  • randomized,double blind, prospective,monocentric, parallel group, intent to treat trial
  • Experiment duration: 5 days
  • 4 visits (days 0,1,3 and 5)
  • Evaluation of symptoms reduction
  • Adverse events evaluation
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be able to understand the study procedures, agree to participate and give written consent.
  2. Patients aged over 12 years of both sexes;
  3. Patients with clinical signs of flu and colds or other upper respiratory allergies;
  4. Patients with early signs and symptoms with time of evolution not more than 48 hours;
  5. Patients with good mental health;
  6. Negative urine pregnancy test

Exclusion Criteria:

  1. Patients treated with antibiotics
  2. Current treatment with immunosuppressants (eg.cyclosporine or methotrexate);
  3. Use of intranasal cromalin the week before inclusion;
  4. Use of decongestants or anti-histaminic (intranasal or systemic);
  5. Presence of any disease or anatomical abnormality that may difficult the data analysis ;
  6. Uncontrolled hypertension;
  7. Presence of respiratory symptoms for more than 14 days;
  8. History of abuse of drugs and alcohol;
  9. Presence of other concomitant pulmonary diseases;
  10. Hypersensitivity to any compound of investigational product
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533220

Locations
Brazil
Instituto Paranaense de Otorrinolaringologia
Curitiba, Parana, Brazil, 80620010
Sponsors and Collaborators
EMS
Investigators
Principal Investigator: Marco César MD Santos, Jorge IPO - PR
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01533220     History of Changes
Other Study ID Numbers: NMPEMS1011
Study First Received: February 9, 2012
Last Updated: September 24, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by EMS:
nasal and nasopharyngeal congestion

Additional relevant MeSH terms:
Respiration Disorders
Hypersensitivity
Respiratory Tract Diseases
Immune System Diseases
Maleic acid
Pheniramine
Naphazoline
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Allergic Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 22, 2014