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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01533220
Recruitment Status : Unknown
Verified September 2013 by EMS.
Recruitment status was:  Active, not recruiting
First Posted : February 15, 2012
Last Update Posted : September 25, 2013
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase
Flu Cold Allergic Disorder of Respiratory System Drug: naphazoline hydrocloride Drug: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol Phase 3

Detailed Description:


  • 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay [ Time Frame: Day 5 ]

    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


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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01533220

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

Responsible Party: EMS Identifier: NCT01533220     History of Changes
Other Study ID Numbers: NMPEMS1011
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013

Keywords provided by EMS:
nasal and nasopharyngeal congestion

Additional relevant MeSH terms:
Respiration Disorders
Immune System Diseases
Respiratory Tract Diseases
Maleic acid
Pantothenic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Vitamin B Complex
Growth Substances
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents