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Evaluation of Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 for 26 Weeks
NA trial testing THS 2.2 in Smoking in 1,039 participants. Completed in 1 August 2017.
| Lead sponsor | Philip Morris Products S.A. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 1,039 |
| Start date | 12 March 2015 |
| Primary completion | 13 September 2016 |
| Estimated completion | 1 August 2017 |
| Sites | 19 locations across United States |
Philip Morris Products S.A. — full company profile →
30 and older, any sex, with Smoking. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.
| Group | Value | 95% CI |
|---|---|---|
| THS 2.2 Use | 54.1 | 51.4 – 56.7 |
| CC Use | 50.9 | 49.4 – 52.4 |
| Dual Use | 56.3 | 52.7 – 59.9 |
| Other Use | 52.8 | 47.4 – 58.1 |
Concentrations measured in blood. Geometric Least Squares means are provided as descriptive statistics.
| Group | Value | 95% CI |
|---|---|---|
| THS 2.2 Use | 6.98 | 6.70 – 7.25 |
| CC Use | 7.48 | 7.28 – 7.69 |
| Dual Use | 7.41 | 7.00 – 7.82 |
| Other Use | 8.71 | 7.80 – 9.62 |
FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Geometric Least Squares means are provided as descriptive statistics.
| Group | Value | 95% CI |
|---|---|---|
| THS 2.2 Use | 95.4 | 93.7 – 97.1 |
| CC Use | 93.4 | 92.0 – 94.8 |
| Dual Use | 93.7 | 91.3 – 96.0 |
| Other Use | 94.3 | 89.3 – 99.4 |
Concentrations measured in serum. Geometric Least Squares means are provided as descriptive statistics.
| Group | Value | 95% CI |
|---|---|---|
| THS 2.2 Use | 252 | 239 – 266 |
| CC Use | 266 | 253 – 279 |
| Dual Use | 270 | 253 – 288 |
| Other Use | 273 | 234 – 317 |
Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
| Group | Value | 95% CI |
|---|---|---|
| THS 2.2 Use | 496 | 446 – 551 |
| CC Use | 523 | 482 – 568 |
| Dual Use | 532 | 464 – 610 |
| Other Use | 626 | 504 – 777 |
Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
| Group | Value | 95% CI |
|---|---|---|
| THS 2.2 Use | 321 | 299 – 344 |
| CC Use | 351 | 334 – 369 |
| Dual Use | 347 | 318 – 377 |
| Other Use | 335 | 281 – 400 |
Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
| Group | Value | 95% CI |
|---|---|---|
| THS 2.2 Use | 144 | 118 – 175 |
| CC Use | 282 | 254 – 314 |
| Dual Use | 286 | 244 – 334 |
| Other Use | 342 | 254 – 460 |
Carboxyhemoglobin (COHb) is assayed from whole blood. Geometric Least Squares means are provided as descriptive statistics. Expressed as % of saturation of hemoglobin.
| Group | Value | 95% CI |
|---|---|---|
| THS 2.2 Use | 2.84 | 2.51 – 3.20 |
| CC Use | 4.38 | 4.16 – 4.61 |
| Dual Use | 4.23 | 3.80 – 4.70 |
| Other Use | 5.59 | 4.87 – 6.41 |
Time frame: The entire study duration per subject was between 32 to 38 weeks, including a Screening period of up to 42 days prior to enrollment, a 6 to 10-day run-in period prior to randomization, followed by a 26 week randomized exposure period. The end of study for a subject was defined as the check-out or the date of early termination of the subject plus the 28 day Safety Follow-up period, unless the subject was lost to follow-up.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | THS 2.2 Group | CC Group | Product Test |
|---|---|---|---|---|
| Pneumonia mycoplasmal | Infections and infestations | — | — | — |
| Cellulitis | Infections and infestations | — | — | — |
| Pyelonephritis acute, with Urosepsis and Nephrolithiasis | Infections and infestations | — | — | — |
| Tooth Infection | Infections and infestations | — | — | — |
| Head injury with seizure | Injury, poisoning and procedural complications | — | — | — |
| Laceration | Injury, poisoning and procedural complications | — | — | — |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Completed suicide | Psychiatric disorders | — | — | — |
| Suicidal ideation | Psychiatric disorders | — | — | — |
| Alcohol abuse | Psychiatric disorders | — | — | — |
| Adjustment disorder with depressed mood and bereavement | Psychiatric disorders | — | — | — |
| Metastases to small intestine with anaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Vertebral osteophyte with Cervical myelopathy | Musculoskeletal and connective tissue disorders | — | — | — |
| Reaction | System | THS 2.2 Group | CC Group | Product Test |
|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | — | — | — |
Most-reported serious reactions: Pneumonia mycoplasmal, Cellulitis, Pyelonephritis acute, with Urosepsis and Nephrolithiasis, Tooth Infection, Head injury with seizure, Laceration, Papillary thyroid cancer, Completed suicide.
Data from ClinicalTrials.gov NCT02396381 adverse events section.
The aim of the study is to demonstrate clinical, biological and functional health changes in smokers switching to the candidate modified risk tobacco product: Tobacco Heating System 2.2 (THS 2.2) as compared to smokers continuing smoking their conventional cigarettes (CC) over a 26-week period. To characterize the study as successful, at least 5 clinical risk endpoints should move in the direction of smoking cessation and these results would be statistically significant. The main analysis will be defined a priori (using the Hailperin-Ruger approach) and will be made between THS 2.2 use and CC use as "per actual product used" and product use categories.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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