Nasal CongestionPhase 3NCT03439436

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

A Phase 3 study testing xylo+dex nasal spray (0.1 mg+5 mg/dose) and Nasic in people with Nasal Congestion, run by McNeil AB at 5 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Nasal Congestion
What is being tested?: xylo+dex nasal spray (0.1 mg+5 mg/dose) and Nasic
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 5 sitesRussia
Study dates: 26 Feb 2018to 2 May 2018
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

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.

Show all 9Show fewer

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.

Who cannot join

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;

Show all 18Show fewer

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;
Use of any menthol containing medications or confectionary including non-prescription medication and/or herbal products within 6 hours of baseline;
Participation in any interventional clinical trials within 30 days before screening or had previous participation in this trial;
Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., Principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each).

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Russia5 sites

Railways clinical hospital n.a.Semashko at Lublino station JSC "RZD"
Moscow, 109386
City Polyclinic #2
Moscow, 117556
First Moscow State Medical University n. a. I. M. Sechenov
Moscow, 119991
"Scientific and Research centre Eco-safety" Limited Liability Company
Saint Petersburg, 196143
The First St. Petersburg state medical University n.a. Acad. I. P. Pavlov
Saint Petersburg, 197022

Other trials in Russia

About this study

Official title: 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.

Read the detailed description

This observer-blind multi-center, randomized, parallel-group study in adults is designed to demonstrate non-inferiority between two formulations of xylometazoline/dexpanthenol nasal sprays in terms of efficacy and safety, when the products are used according to labeled instructions in a home based setting.

Subjects suffering from nasal congestion caused by acute Upper Respiratory Tract Infection (URTI) and seeking medical counselling, will after screening and baseline assessment of nasal congestion, be randomized, and perform additional baseline subjective assessments of nasal rhinorrhea (scores on categorical scales). The Investigator will perform subjective baseline assessments of crust formation and dryness, redness and edema of nasal mucosa (anterior rhinoscopy using nasal speculum or otoscope).

After the baseline assessments, the subjects will receive xylometazoline/dexpanthenol nasal spray or marketed reference nasal spray according to randomization.The first dose will be taken at the site under supervision. The study nurse will schedule visits for 24 hours, 72 hours and 120 hours after this first dose and the subjects will be released for home based treatment. At the 72-hour visit, the primary and secondary efficacy endpoints will be assessed by the subject and the Investigator, safety will be followed up and subjects will also evaluate the treatment in a global assessment. At the 24-hour visit and at the final visit, after a maximum of 5 full days (120 hours) of treatment, all secondary endpoints will be assessed and safety will be followed up.

Conditions: Nasal Congestion
Being tested: xylo+dex nasal spray (0.1 mg+5 mg/dose), Nasic
Medical subject headings: Nasal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

xylo+dex nasal spray (0.1 mg+5 mg/dose)Drug
Also called xylo+dex metered nasal spray (0.1 mg+5 mg/dose)
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.
NasicDrug
Also called xylo+dex metered nasal spray (0.1 mg+5 mg/dose)
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.

Study groups in NCT03439436
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Nasic

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: After 72 hours of treatment.

Secondary outcomes (11)

Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.
Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.
Measured: At 24 and 120 hours post dose.
Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.
Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.
Measured: At 24 hours, 72 and 120 hours post dose
Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.
Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.
Measured: 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.
Assessment of dryness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Measured: 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.
Assessment of redness of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Measured: At 24 hours, 72 hours and 120 hours post dose.
Assessment of edema of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Assessment of edema of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Measured: At 24 hours, 72 hours and 120 hours post dose
Global evaluation assessments of study treatment by subjects at 72 hours post dose.
Global evaluation assessments of study treatment by subjects at 72 hours post dose.
Measured: At 72 hours post dose.
Frequency and severity of treatment emergent AEs reported during the study.
Each treatment emergent AE reported during the trial and it´s severity will be tabulated in a list, capturing frequency and severity of all treatment emergent AEs occuring during the trial.
Measured: Through study completion, an average of 5 months.
Frequency and severity of AEs possibly, probably, or very likely related to the study drug during study treatment.
Each AE which has been ranked as possibly, probably, or very likely related to the study drug during study treatment will be tabulated in a list capturing frequency and severity of all these AEs occuring during the trial.
Measured: Through study completion, an average of 5 months.
Occurrence of serious AEs (SAEs).
Occurrence of serious AEs (SAEs), will be tabulated in a list.
Measured: Through study completion, an average of 5 months.
Occurence of AEs resulting in pre-mature withdrawal from the study.
Occurence of AEs resulting in pre-mature withdrawal from the study will be tabulated in a list.
Measured: Througout study completion, an average of 5 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 20182 May 2018

First posted20 Feb 2018
Study start26 Feb 2018
Primary completion2 May 2018
Study completion2 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nasal CongestionStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03439436
Sponsor's protocol ID: CO-170117145845-URCT
Status last verified: Oct 2018
First submitted: 15 Jan 2018
Last updated: 18 Oct 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
RecruitingPhase 3
Fixed-dose Combination of 1000 mg Dipyrone Monohydrate + 60 mg Caffeine + 4 mg Chlorpheniramine Maleate in Improving Symptoms of the Common Cold and Flu in Adults
Common Cold/Flu, Nasal Congestion
Not yet recruitingObservational study
Observational Study of RHINOSEDAL in Acute Nasal Obstruction
Nasal Obstruction, Common Cold
Active, not recruiting
Laser Posterior Nasal Nerve Neurolysis
Allergic Rhinitis, Chronic Rhinitis
Not yet recruiting
Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion
Atopic Rhinitis, Atopic Asthma

All Nasal Congestion trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT03439436
Acronym / sponsor ID: CO-170117145845-URCT
Conditions: Nasal Congestion
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: McNeil ABIndustry (pharma, biotech, devices)
Study start: 26 Feb 2018 (actual)
Primary completion: 2 May 2018 (actual)
Study completion: 2 May 2018 (actual)
First posted: 20 Feb 2018 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
xylo+dex nasal spray (0.1 mg+5 mg/dose)	Experimental	Drug: xylo+dex nasal spray (0.1 mg+5 mg/dose)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.
Nasic	Active comparator	Drug: NasicXylometazoline+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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (18 listed)

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);

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

Primary outcome

Change from baseline in self-assessment of nasal congestion after 72 hours of treatment.
Time frame: After 72 hours of treatment.
Change from baseline in self-assessment of nasal congestion after 72 hours of treatment.

11 secondary outcomes

Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.
Time frame: At 24 and 120 hours post dose.
Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.
Time frame: At 24 hours, 72 and 120 hours post dose
Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.
Time frame: 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.
Time frame: 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.
Time frame: At 24 hours, 72 hours and 120 hours post dose.
Assessment of edema of nasal mucosa after 24 hours, 72 hours and 120 hours post dose.
Time frame: At 24 hours, 72 hours and 120 hours post dose
Global evaluation assessments of study treatment by subjects at 72 hours post dose.
Time frame: At 72 hours post dose.
Frequency and severity of treatment emergent AEs reported during the study.
Time frame: Through study completion, an average of 5 months.
Frequency and severity of AEs possibly, probably, or very likely related to the study drug during study treatment.
Time frame: Through study completion, an average of 5 months.
Occurrence of serious AEs (SAEs).
Time frame: Through study completion, an average of 5 months.
Occurence of AEs resulting in pre-mature withdrawal from the study.
Time frame: Througout study completion, an average of 5 months.

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 18 Oct 2018.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Nasal Congestion

Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
RecruitingPhase 3
Fixed-dose Combination of 1000 mg Dipyrone Monohydrate + 60 mg Caffeine + 4 mg Chlorpheniramine Maleate in Improving Symptoms of the Common Cold and Flu in Adults
Common Cold/Flu, Nasal Congestion
Not yet recruitingObservational study
Observational Study of RHINOSEDAL in Acute Nasal Obstruction
Nasal Obstruction, Common Cold
Active, not recruiting
Laser Posterior Nasal Nerve Neurolysis
Allergic Rhinitis, Chronic Rhinitis
Not yet recruiting
Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion
Atopic Rhinitis, Atopic Asthma

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.

Dmitry Lioznov, MD principal investigator

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

Tatiana E Morozova, MD principal investigator

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

Vladimir Popov, MD principal investigator

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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing xylo+dex nasal spray (0.1 mg+5 mg/dose) and Nasic in people with Nasal Congestion, run by McNeil AB at 5 sites in Russia.

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 9 inclusion and 18 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 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Change from baseline in self-assessment of nasal congestion after 72 hours of treatment. (time frame: After 72 hours of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03439436.

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 18 Oct 2018.