SmokersNCT03086707

Prefatory Study to Explore Changes in Nasal Mucociliary Clearance and to Standardize Nasal Scraping Procedure

A study testing Cigarette in people with Smokers and Never Smokers, run by Philip Morris Products S.A. at 2 sites in United States.

Completed

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

Official record

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Trial summary

This study intends to evaluate the nasal mucociliary clearance (NMC) by determining the value obtained for saccharin transit time (STT) test over the course of 12 hours following a single cigarette use in adult smokers, to compare it relative to never smokers, and to examine the relationship between plasma nicotine… Read more about this study

Who is it for?: Ages 25 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Smokers, Never Smokers
What is being tested?: Cigarette
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 2 sitesUnited States
Study dates: 21 Jan 2017to 29 Sep 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male smokers aged ≥25 to ≤45 years old.
Male never smokers aged ≥25 to ≤45 years old.
Subject's BMI is comprised between 18.0 kg/m2 to 32.0 kg/m2, inclusive.
Subject is healthy, as judged by the Investigator.
Additional Inclusion Criteria to allocate subjects in one of the two groups:
Non-menthol cigarette smokers:

Show all 14Show fewer

A positive urine cotinine test (≥200 ng/mL).
Smoked at least 20 cigarettes per day for at least the past 5 years.
eCO levels >10 parts per million (ppm).
No plans to quit smoking in the next 3 months.
Never smokers:
Subject who has smoked less than 100 cigarettes throughout their lifetime and no cigarettes in the past 3 years.
A negative urine cotinine test (<200 ng/mL).
eCO levels ≤ 5 ppm.

Who cannot join

As per the Investigator's judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
Inability to taste sweet within 60 minutes in the STT test.
Any condition the Principal Investigator or designee has cause to believe would interfere with the procedures for upper or lower airway function. This could include, but is not limited to, nasal/septum deviations, or nasal polyps or nasal allergies.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Inflamax Research - Neptune
Neptune City, New Jersey, 07753
Inflamax Research - Newark
Newark, New Jersey, 07105

Other trials in United States

About this study

Official title: A Two-arm, Open Label, Prefatory Study to Explore Changes in Nasal Mucociliary Clearance Between Smokers and Never Smokers and to Standardize Nasal Scraping Procedure

The planned maximum study duration for a single study participant from Screening through completion of study will be 33 days.

Conditions: Smokers, Never Smokers
Being tested: Cigarette
Keywords: nasal mucociliary clearance, saccharine transit time

What participants receive

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

CigaretteOther
After enrollment, and between Visit 2 and Visit 3, the subjects will abstain from smoking for a period of 8 hours. At Visit 3, after the 8-hour smoking abstinence period, the subjects will smoke 1 single cigarette.

Study groups in NCT03086707
Study group	Role	What they receive
Cigarette smokers	Active comparator	Subjects who have smoked at least 20 cigarettes per day for at least the past 5 years. Subjects will be allowed to use their own brand of non-menthol cigarettes. There will be no smoking restriction after the discharge at Visit 3 and during the 1 day follow-up period. Receives: Other: Cigarette
Never smokers	No intervention	Subjects who have smoked less than 100 cigarettes throughout their lifetime and no cigarettes in the past 3 years. Subjects will not be allowed to smoke until discharge at Visit 3.

What is being measured

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

Saccharin Transit Time at t0, Start of Product Use
Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment.
The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Measured: Baseline
Saccharin Transit Time 4 Hours After Product Use
Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment.
The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Measured: Measured at 4 hours after product use.
Saccharin Transit Time 8 Hours After Product Use
Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment.
The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Measured: Measured at 8 hours after product use.
Saccharin Transit Time 12 Hours After Product Use
Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment.
The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Measured: Measured at 12 hours after product use.
Concentration of Plasma Nicotine at t0, Start of Product Use
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Measured: Baseline
Concentration of Plasma Nicotine 4 Hours After Product Use
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Measured: Measured at 4 hours after product use.
Concentration of Plasma Nicotine 8 Hours After Product Use
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Measured: Measured at 8 hours after product use.
Concentration of Plasma Nicotine 12 Hours After Product Use
The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Measured: Measured at 12 hours after product use.

Secondary outcomes (4)

Ribonucleic Acid Quantity (Right Nostril)
Ribonucleic Acid quantity: concentration measured in the right nostril (RNA protect buffer) using two nasal scraping methods
Measured: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quantity (Left Nostril)
Ribonucleic Acid quantity: concentration measured in the left nostril (Qiazol buffer) using two nasal scraping methods
Measured: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quality (Right Nostril)
Ribonucleic Acid quality assessed using the RNA integrity number: measured in the right nostril (RNA protect buffer) using two nasal scraping methods. RNA integrity Number is an algorithm for assessing RNA integrity and based on a numbering system from 1 to 10, with 1 being the most degraded profile and 10 being the most intact.
Measured: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quality (Left Nostril)
Ribonucleic Acid quality assessed using the RNA integrity number: measured in the left nostril (Qiazol buffer) using two nasal scraping methods. RNA integrity Number is an algorithm for assessing RNA integrity and based on a numbering system from 1 to 10, with 1 being the most degraded profile and 10 being the most intact.
Measured: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.

Timeline

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

21 Jan 201729 Sep 2017

First posted22 Mar 2017
Study start21 Jan 2017
Primary completion14 Aug 2017
Study completion29 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokersStudies 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 N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03086707
Sponsor's protocol ID: P1-CMS-01-US
Status last verified: Oct 2020
First submitted: 16 Mar 2017
Last updated: 20 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No individual participant data will be made available.

Publications

Schroeder A, Mueller O, Stocker S, Salowsky R, Leiber M, Gassmann M, Lightfoot S, Menzel W, Granzow M, Ragg T. The RIN: an RNA integrity number for assigning integrity values to RNA measurements. BMC Mol Biol. 2006 Jan 31;7:3. doi: 10.1186/1471-2199-7-3.
PubMed 16448564

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

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All Smokers trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-arm, Open Label, Prefatory Study to Explore Changes in Nasal Mucociliary Clearance Between Smokers and Never Smokers and to Standardize Nasal Scraping Procedure
ClinicalTrials.gov ID: NCT03086707
Acronym / sponsor ID: P1-CMS-01-US
Conditions: Smokers, Never Smokers
Keywords: nasal mucociliary clearance, saccharine transit time
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Philip Morris Products S.A.Industry (pharma, biotech, devices)
Study start: 21 Jan 2017 (actual)
Primary completion: 14 Aug 2017 (actual)
Study completion: 29 Sep 2017 (actual)
First posted: 22 Mar 2017 (actual)
Results: Posted 23 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The planned maximum study duration for a single study participant from Screening through completion of study will be 33 days.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cigarette smokers	Active comparator	Other: CigaretteSubjects who have smoked at least 20 cigarettes per day for at least the past 5 years. Subjects will be allowed to use their own brand of non-menthol cigarettes. There will be no smoking restriction after the discharge at Visit 3 and during the 1 day follow-up period.
Never smokers	No intervention	–Subjects who have smoked less than 100 cigarettes throughout their lifetime and no cigarettes in the past 3 years. Subjects will not be allowed to smoke until discharge at Visit 3.

Who may qualify

Ages: 25 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Male smokers aged ≥25 to ≤45 years old.
Male never smokers aged ≥25 to ≤45 years old.
Subject's BMI is comprised between 18.0 kg/m2 to 32.0 kg/m2, inclusive.
Subject is healthy, as judged by the Investigator.
Non-menthol cigarette smokers:

Key exclusion criteria (3 listed)

As per the Investigator's judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
Inability to taste sweet within 60 minutes in the STT test.
Any condition the Principal Investigator or designee has cause to believe would interfere with the procedures for upper or lower airway function. This could include, but is not limited to, nasal/septum deviations, or nasal polyps or nasal allergies.

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
CigaretteAfter enrollment, and between Visit 2 and Visit 3, the subjects will abstain from smoking for a period of 8 hours. At Visit 3, after the 8-hour smoking abstinence period, the subjects will smoke 1 single cigarette.	Other	Cigarette smokers

Primary outcome

Saccharin Transit Time at t0, Start of Product Use
Time frame: Baseline
Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment. The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Saccharin Transit Time 4 Hours After Product Use
Time frame: Measured at 4 hours after product use.
Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment. The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Saccharin Transit Time 8 Hours After Product Use
Time frame: Measured at 8 hours after product use.
Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment. The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Saccharin Transit Time 12 Hours After Product Use
Time frame: Measured at 12 hours after product use.
Before performing the test, each subject will spend approximately 15 minutes acclimatizing to the environment of the clinic. A 1-2 mm particle of saccharin will be placed under direct vision, approximately 1 cm behind the anterior end of the inferior turbinate. The position of the subject's head should be flexed approximately 10° by visual assessment. The saccharin transit time will be determined as the elapsed time in minutes and seconds from placement of the saccharin until the time the subject perceives a sweet taste.
Concentration of Plasma Nicotine at t0, Start of Product Use
Time frame: Baseline
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Concentration of Plasma Nicotine 4 Hours After Product Use
Time frame: Measured at 4 hours after product use.
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Concentration of Plasma Nicotine 8 Hours After Product Use
Time frame: Measured at 8 hours after product use.
Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.
Concentration of Plasma Nicotine 12 Hours After Product Use
Time frame: Measured at 12 hours after product use.
The Nicotine plasma concentrations will be measured using validated LC/MS/MS bioanalytical method.

4 secondary outcomes

Ribonucleic Acid Quantity (Right Nostril)
Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quantity (Left Nostril)
Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quality (Right Nostril)
Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.
Ribonucleic Acid Quality (Left Nostril)
Time frame: Nasal scraping was performed at the final clinic visit, on Day 2, before checkout from the study.

Results and safety

Results posted to the registry on 23 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cigarette Smokers	7	7
Never Smokers	7	7

Primary outcome: Saccharin Transit Time at t0, Start of Product Use

Time frame: Baseline. Mean (95% Confidence Interval). Unit: minutes

Measure	Cigarette Smokers n = 7	Never Smokers n = 7
Value	8.4 (4.81 to 11.89)	10.1 (4.05 to 16.21)

Primary outcome: Saccharin Transit Time 4 Hours After Product Use

Time frame: Measured at 4 hours after product use.. Mean (95% Confidence Interval). Unit: minutes

Measure	Cigarette Smokers n = 7	Never Smokers n = 7
Value	8.0 (5.83 to 10.12)	7.1 (1.98 to 12.28)

Primary outcome: Saccharin Transit Time 8 Hours After Product Use

Time frame: Measured at 8 hours after product use.. Mean (95% Confidence Interval). Unit: minutes

Measure	Cigarette Smokers n = 7	Never Smokers n = 7
Value	9.9 (3.25 to 16.57)	10.1 (3.03 to 17.11)

Primary outcome: Saccharin Transit Time 12 Hours After Product Use

Time frame: Measured at 12 hours after product use.. Mean (95% Confidence Interval). Unit: minutes

Measure	Cigarette Smokers n = 7	Never Smokers n = 7
Value	8.6 (5.34 to 11.78)	9.0 (2.61 to 15.47)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over the entire study duration of up to 7 months, with individual subject participation of a maximum of 33 days from the signature of the Informed Consent Form (ICF) until the end of the safety follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cigarette Smokers	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
Never Smokers	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16448564Schroeder A, Mueller O, Stocker S, Salowsky R, Leiber M, Gassmann M, Lightfoot S, Menzel W, Granzow M, Ragg T. The RIN: an RNA integrity number for assigning integrity values to RNA measurements. BMC Mol Biol. 2006 Jan 31;7:3. doi: 10.1186/1471-2199-7-3.
Individual participant dataSharing planned: No. No individual participant data will be made available.

Related trials for Smokers

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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.

Christelle Haziza, PhD study chair

Philip Morris Products S.A.

Frank Lee, MD principal investigator

Inflamax Research - Neptune

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

Questions about this trial

What is this clinical trial studying?

A study testing Cigarette in people with Smokers and Never Smokers, run by Philip Morris Products S.A. at 2 sites in United States.

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 14 inclusion and 3 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 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Saccharin Transit Time at t0, Start of Product Use (time frame: Baseline). The study lists 8 primary outcomes in all. 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 NCT03086707, which also lists 1 linked publication.

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 20 Nov 2020.