Trial Outcomes & Findings for Telehealth-Filter Ventilation ( COMET2P1 ) (NCT NCT04969783)
NCT ID: NCT04969783
Last Updated: 2025-05-08
Results Overview
Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit (ng/g creatinine) measured in urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
6 weeks randomized intervention
Results posted on
2025-05-08
Participant Flow
Participant milestones
| Measure |
Ventilated Cigarette Filter
Filters with approximately 24-32% filter ventilation
Ventilated Cigarette Filter: Ventilated Cigarette Filter
|
Unventilated Cigarette Filter
Filters with approximately 0-5.0% filter ventilation
Unventilated Cigarette Filter: Unventilated Cigarette Filter
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
84
|
|
Overall Study
COMPLETED
|
68
|
84
|
|
Overall Study
NOT COMPLETED
|
12
|
0
|
Reasons for withdrawal
| Measure |
Ventilated Cigarette Filter
Filters with approximately 24-32% filter ventilation
Ventilated Cigarette Filter: Ventilated Cigarette Filter
|
Unventilated Cigarette Filter
Filters with approximately 0-5.0% filter ventilation
Unventilated Cigarette Filter: Unventilated Cigarette Filter
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Physician Decision
|
6
|
0
|
Baseline Characteristics
Telehealth-Filter Ventilation ( COMET2P1 )
Baseline characteristics by cohort
| Measure |
Ventilated Cigarette Filter
n=80 Participants
Filters with approximately 24-32% filter ventilation
Ventilated Cigarette Filter: Ventilated Cigarette Filter
|
Unventilated Cigarette Filter
n=84 Participants
Filters with approximately 0-5.0% filter ventilation
Unventilated Cigarette Filter: Unventilated Cigarette Filter
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
78 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
84 participants
n=7 Participants
|
164 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks randomized interventionAbsolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit (ng/g creatinine) measured in urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Outcome measures
| Measure |
Ventilated Cigarette Filter
n=67 Participants
Filters with approximately 24-32% filter ventilation
Ventilated Cigarette Filter: Ventilated Cigarette Filter
|
Unventilated Cigarette Filter
n=82 Participants
Filters with approximately 0-5.0% filter ventilation
Unventilated Cigarette Filter: Unventilated Cigarette Filter
|
|---|---|---|
|
Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]
|
0.97 ng/g creatinine
Interval 0.82 to 1.24
|
1.05 ng/g creatinine
Interval 0.84 to 1.35
|
PRIMARY outcome
Timeframe: 7 days prior to week 0 visit and 7 days prior to week 6 visitChange in cigarettes per day, daily diary reviewed data.
Outcome measures
| Measure |
Ventilated Cigarette Filter
n=68 Participants
Filters with approximately 24-32% filter ventilation
Ventilated Cigarette Filter: Ventilated Cigarette Filter
|
Unventilated Cigarette Filter
n=84 Participants
Filters with approximately 0-5.0% filter ventilation
Unventilated Cigarette Filter: Unventilated Cigarette Filter
|
|---|---|---|
|
Change in Cigarettes Per Day (CPD)
|
-0.39 Cigarettes per day
Standard Deviation 2.73
|
-0.17 Cigarettes per day
Standard Deviation 3.41
|
Adverse Events
Ventilated Cigarette Filter
Serious events: 1 serious events
Other events: 73 other events
Deaths: 0 deaths
Unventilated Cigarette Filter
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ventilated Cigarette Filter
n=80 participants at risk
Filters with approximately 24-32% filter ventilation
Ventilated Cigarette Filter: Ventilated Cigarette Filter
|
Unventilated Cigarette Filter
n=84 participants at risk
Filters with approximately 0-5.0% filter ventilation
Unventilated Cigarette Filter: Unventilated Cigarette Filter
|
|---|---|---|
|
Vascular disorders
Superficial blood clot in lower leg
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
Other adverse events
| Measure |
Ventilated Cigarette Filter
n=80 participants at risk
Filters with approximately 24-32% filter ventilation
Ventilated Cigarette Filter: Ventilated Cigarette Filter
|
Unventilated Cigarette Filter
n=84 participants at risk
Filters with approximately 0-5.0% filter ventilation
Unventilated Cigarette Filter: Unventilated Cigarette Filter
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion (incl. runny nose)
|
11.2%
9/80 • Number of events 10 • 6 months
|
9.5%
8/84 • Number of events 9 • 6 months
|
|
Nervous system disorders
Headache (incl. migraine)
|
8.8%
7/80 • Number of events 8 • 6 months
|
10.7%
9/84 • Number of events 9 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
4/80 • Number of events 4 • 6 months
|
10.7%
9/84 • Number of events 10 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore/itchy/irritated throat
|
5.0%
4/80 • Number of events 4 • 6 months
|
10.7%
9/84 • Number of events 10 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
6.2%
5/80 • Number of events 5 • 6 months
|
2.4%
2/84 • Number of events 2 • 6 months
|
|
Infections and infestations
COVID-19
|
3.8%
3/80 • Number of events 3 • 6 months
|
4.8%
4/84 • Number of events 4 • 6 months
|
|
General disorders
Fatigue
|
3.8%
3/80 • Number of events 3 • 6 months
|
4.8%
4/84 • Number of events 4 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia (muscle aches/pain/spasms)
|
5.0%
4/80 • Number of events 4 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough, Productive (lung 'fullness')
|
2.5%
2/80 • Number of events 2 • 6 months
|
3.6%
3/84 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
3/80 • Number of events 3 • 6 months
|
2.4%
2/84 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (incl. seasonal allergies)
|
0.00%
0/80 • 6 months
|
4.8%
4/84 • Number of events 4 • 6 months
|
|
Psychiatric disorders
Depressed (sad) mood
|
2.5%
2/80 • Number of events 2 • 6 months
|
2.4%
2/84 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/80 • Number of events 3 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypertension / Elevated BP
|
2.5%
2/80 • Number of events 2 • 6 months
|
2.4%
2/84 • Number of events 2 • 6 months
|
|
General disorders
Pain (other)
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
|
Psychiatric disorders
Anxious (nervous) mood
|
0.00%
0/80 • 6 months
|
3.6%
3/84 • Number of events 3 • 6 months
|
|
General disorders
Fever
|
2.5%
2/80 • Number of events 2 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Ear and labyrinth disorders
Ear Pain (ache/fullness)
|
3.8%
3/80 • Number of events 3 • 6 months
|
0.00%
0/84 • 6 months
|
|
General disorders
Chills
|
2.5%
2/80 • Number of events 2 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Infections and infestations
Infections and Infestations - Other, Specify
|
2.5%
2/80 • Number of events 2 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Cardiac disorders
Tachycardia / Fast heart rate
|
1.2%
1/80 • Number of events 1 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Oral dysesthesia (burning/tingling/numbness/pain)
|
1.2%
1/80 • Number of events 1 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Nervous system disorders
Sinus Pain
|
0.00%
0/80 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Surgical and medical procedures, Other, Specify
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
|
Nervous system disorders
Dysgeusia (change in taste/smell)
|
0.00%
0/80 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/80 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Infections and infestations
Influenza (PCP dx; cough/lung sx separately)
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
|
Injury, poisoning and procedural complications
Bruising
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
|
Infections and infestations
Sinusitis - sinus infection (incl. bacterial, fungal, viral)
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
|
Nervous system disorders
Neuralgia / Neuropathy (nerve pain)
|
0.00%
0/80 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Stomach Pain
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
|
Investigations
Investigations - Other abnormal lab, low blood oxygen
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux (GERD/heartburn/acid)
|
0.00%
0/80 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/80 • 6 months
|
1.2%
1/84 • Number of events 1 • 6 months
|
|
Vascular disorders
Hypotension / Low BP
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
|
Injury, poisoning and procedural complications
Sprained joint
|
2.5%
2/80 • Number of events 2 • 6 months
|
0.00%
0/84 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Phlegm, increase in
|
1.2%
1/80 • Number of events 1 • 6 months
|
0.00%
0/84 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place