N/A
Completed N=720
A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation
Cigarette Smoking
Source: ClinicalTrials.gov NCT02432729 ↗
Enrolled (actual)
720
Serious AEs
1.4%
Results posted
Aug 2019
Primary outcomePrimary: High Density Lipoprotein C (HDL-C). — 57.1; 58.9; 58.6 mg/dL
Summary
The purpose of this study was to understand the biological and functional changes after one year of smoking cessation and to collect data on a broad range of biomarkers of exposure (BoExp) and biomarkers of effect (BoE).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High Density Lipoprotein C (HDL-C). |
57.1; 58.9; 58.6 | — |
| PRIMARY Low-density Lipoprotein Cholesterol (LDL-C) |
131; 136; 138 | — |
| PRIMARY Apo A1 |
155; 158; 155 | — |
| PRIMARY Apo B |
94.3; 96.3; 97.5 | — |
| PRIMARY White Blood Cells (WBC). |
6.72; 5.94; 5.93 | — |
| PRIMARY Hs-CRP |
0.856; 0.841; 0.963 | — |
| PRIMARY Homocysteine |
12.6; 11.4; 11.7 | — |
| PRIMARY Fibrinogen |
326; 310; 312 | — |
| PRIMARY Platelets |
239; 240; 241 | — |
| PRIMARY 11-dehydrothromboxane B2 (11-DTXB2). |
572; 433; 436 | — |
| PRIMARY 8-epi-prostaglandin F2α (8-epi-PGF2α). |
242; 199; 189 | — |
| PRIMARY MPO |
133; 144; 202 | — |
| PRIMARY Soluble Intercellular Adhesion Molecule 1 (sICAM-1). |
229; 201; 194 | — |
| PRIMARY Albumin |
5.68; 5.69; 5.51 | — |
| PRIMARY Carboxyhemoglobin (COHb). |
2.78; 0.724; 0.758 | — |
| PRIMARY HbA1c |
5.42; 5.39; 5.45 | — |
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1), Pre-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred). |
94.5; 94.2; 93.9 | — |
| PRIMARY FEV1 Post-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred). |
97.1; 96.7; 96.5 | — |
| PRIMARY Forced Vital Capacity (FVC) Pre-bronchodilator, Expressed as Percentage Predicted (FVC %Pred). |
101; 100; 99.1 | — |
| PRIMARY FVC Post-bronchodilator, Expressed as Percentage Predicted (FVC %Pred). |
100; 99.5; 98.6 | — |
| PRIMARY FEV1/FVC Pre-bronchodilator Expressed as a Ratio |
0.771; 0.77; 0.778 | — |
| PRIMARY FEV1/FVC Post-bronchodilator Expressed as a Ratio |
0.796; 0.797; 0.803 | — |
| PRIMARY FEF 25-75 Forced Expiratory Flow, Pre-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred) |
84.8; 84.2; 86.6 | — |
| PRIMARY FEF 25-75 Forced Expiratory Flow, Post-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred) |
95.7; 95.8; 98.1 | — |
| PRIMARY Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL). |
125; 5.11; 4.37 | — |
Eligibility Criteria
Inclusion Criteria
- Current healthy smoker as judged by the Principal Investigator(s) or designee(s).
- Subject is aged from 30 to 65 years old (inclusive).
- Subject has smoked for at least the last 10 years.
- Subject smoked more than 10 cigarettes/day on average over the last year.
- Subject is willing to quit smoking within the next 30 days.
Exclusion Criteria
- Subject has clinically relevant medical conditions that in the opinion of the Investigators would jeopardize the safety of the participant or affect the validity of the study results.
- Subject has Forced Expiratory Volume in 1 second/Forced Vital Capacity(FEV1/FVC) 12% and > 200 ml from pre- to post-bronchodilator values.
- Subject who took or is taking concomitant medication which may have an impact on the biomarkers of effect.
- Female subject is pregnant or is a breast-feeding.
Data sourced from ClinicalTrials.gov (NCT02432729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.