Study of Nicotine Patches in Patients With Sarcoidosis

What Was Tested

In this early phase 1 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The purpose of this study is to compare peoples with disease (sarcoidosis) to those without disease.

The researchers want to see if people with sarcoidosis have a different immune response to those people without disease.

The goal of this study is to see if the nicotine patch is an anti-inflammatory treatment for sarcoidosis.

It had three arms (groups): 2. (no intervention), 3 (no intervention) and 1. (experimental).

Control group-no intervention.

Healthy control group-blood and sputum samples.

The registry classes the interventions as drug.

More on the Plan

Sarcoidosis patients who volunteer to participate in this study will submit standardized questionnaires relating to their quality of life and the severity of their shortness of breath before and after treatment.

The researchers will also compare objective measures of lung function, radiographic parameters, and the severity of lung inflammation.

If their hypothesis is proven to be correct in this relatively small group of patients, the researchers will perform additional studies in a larger group of patients and will consider the features of sarcoidosis patients that predict a favorable response to nicotine and other nicotine-like drugs.

Who Took Part

64 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: • active smokers,; previous splenectomy,; we will also exclude patients with extensive pulmonary fibrosis based upon lung biopsy or high resolution ct scan criterion.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

It started in 2008-07 with completion listed for 2010-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 64 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.