A Study to Compare Two Formulations of Xylometazoline/Dexpanthenol Nasal Spray for the Treatment of Nasal Congestion.

NCT03439436 | Completed Phase 3

• 1 other identifier: CO-170117145845-URCT
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

Brief Summary

An observer-blind, multi-centre, randomized, parallel-group study to compare the efficacy and safety of two formulations of xylometazoline/dexpanthenol nasal spray for the treatment of nasal congestion caused by an acute upper respiratory tract infection in adults.

Conditions

Nasal Congestion

Outcome Measures

Primary Outcomes (1)

• Change from baseline in self-assessment of nasal congestion after 72 hours of treatment.

  Change from baseline in self-assessment of nasal congestion after 72 hours of treatment.

  After 72 hours of treatment.

Secondary Outcomes (11)

• Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.

  At 24 and 120 hours post dose.

• Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.

  At 24 hours, 72 and 120 hours post dose

• Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.

  At 24 hours, 72 hours and 120 hours post dose.

• Assessment of dryness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.

  At 24 hours, 72 hours and 120 hours post dose.

• Assessment of redness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.

  At 24 hours, 72 hours and 120 hours post dose.

Other Outcomes (1)

• Subject compliance with the study medication dosing regimen by reporting of doses taken in subject diary.

  Through study completion, an average of 5 months.

Study Arms (2)

xylo+dex nasal spray (0.1 mg+5 mg/dose)

EXPERIMENTAL

Xylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.

Drug: xylo+dex nasal spray (0.1 mg+5 mg/dose)

Nasic

ACTIVE COMPARATOR

Xylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.

Drug: Nasic

Interventions

xylo+dex nasal spray (0.1 mg+5 mg/dose) DRUG

Xylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.

Also known as: xylo+dex metered nasal spray (0.1 mg+5 mg/dose)

xylo+dex nasal spray (0.1 mg+5 mg/dose)

Nasic DRUG

Xylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.

Also known as: xylo+dex metered nasal spray (0.1 mg+5 mg/dose)

Nasic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of 18 years of age or older;
• Subjects suffering from nasal congestion with a clinical diagnosis of acute upper respiratory tract infection where symptoms of nasal congestion have persisted for minimum of 3 hours and maximum of 36 hours;
• Body mass index (BMI) 18.5 to 35 (inclusive) at screening;
• Indicate at least moderate congestion on a categorical scale ranging from (0) none, (1) mild, (2) moderate, (3) severe or (4) very severe, completed at screening and at baseline;
• Females of childbearing potential must have a negative urine pregnancy test at screening;
• Male and non-pregnant, non-lactating females must agree to the contraceptive requirements (including female partners' use of highly effective form of birth control for at least 3 months before the study, during the study and up to 30 days after the last dose of investigational products) as outlined in protocol.
• Are able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel´s assessment;
• Are able to read and understand the local language;
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

You may not qualify if:

• Females who are pregnant, breastfeeding or trying to conceive;
• Male with a pregnant partner or a partner who is currently trying to conceive;
• Have a known allergy or hypersensitivity to xylometazoline, dexpanthenol or any of the excipients of the formulations;
• Presence or history of a medical condition in the investigator's opinion that may jeopardize the subject´s safety or well-being, or the integrity of the study (e.g., hepatic, renal, pancreatic, gastrointestinal, cardiovascular, cerebrovascular, thyroid, seizure, asthma, allergy, drug intolerance, or psychiatric disorders; uncontrolled hypertension indicated as systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg; or uncontrolled diabetes in the last 6 months);
• Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
• Clinically significant laboratory abnormality that cannot be explained by the acute upper respiratory tract infection;
• Presenting axillary temperature of 38.5 Celsius degrees or above;
• Acute and/or chronic respiratory tract disease or other concomitant disease with potential to compromise breathing (asthma, bronchopneumonia);
• Chronic ear, nose and throat (ENT) conditions e.g. nasal polyps, perennial or seasonal allergic rhinitis, or significant nasal septum deviation;
• Suspected fungal upper respiratory tract infection e.g., candida infection;
• Known or suspected bacterial upper respiratory tract infection or purulent pharyngitis;
• Have contraindicated conditions: arterial hypertension, tachycardia, marked atherosclerosis, atrophic rhinitis, rhinitis sicca, hyperthyroidism, porphyria, prostatic hyperplasia, glaucoma, previous surgical intervention on the meninges;
• Are currently taking monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants;
• Use of any analgesic, antipyretic or "cold and flu" medication including non-prescription medication and/or herbal products within previous 8 hours, for naproxen containing products within previous 12 hours;
• Use of any nasal or oral decongestant including non-prescription medication and/or herbal products for the presenting episode of nasal congestion;

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (5)

Railways clinical hospital n.a.Semashko at Lublino station JSC "RZD"

Moscow, 109386, Russia

Location

City Polyclinic #2

Moscow, 117556, Russia

Location

First Moscow State Medical University n. a. I. M. Sechenov

Moscow, 119991, Russia

Location

"Scientific and Research centre Eco-safety" Limited Liability Company

Saint Petersburg, 196143, Russia

Location

The First St. Petersburg state medical University n.a. Acad. I. P. Pavlov

Saint Petersburg, 197022, Russia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Dmitry Lioznov, MD

  The First St. Petersburg state medical University n.a. Acad. I. P. Pavlov

  PRINCIPAL INVESTIGATOR

• Tatiana E Morozova, MD

  First Moscow State Medical University n. a. I. M. Sechenov

  PRINCIPAL INVESTIGATOR

• Vladimir Popov, MD

  Railways clinical hospital n.a.Semashko at Lublino station JSC "RZD"

  PRINCIPAL INVESTIGATOR

• Zhanna M Sizova, MD

  City Polyclinic #2

  PRINCIPAL INVESTIGATOR

• Konstantin A Zakharov, MD

  "Scientific and Research centre Eco-safety" Limited Liability Company

  PRINCIPAL INVESTIGATOR

• Alison Hughes

  R&D MedClin EMEA, J&J

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Bottles kept in neutral outer boxes. Staff performing assessments kept unaware of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 20, 2018
• Study Start: February 26, 2018
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (5)