Inhaled Glutathione (GSH) Versus Placebo in Cystic Fibrosis

What Was Tested

In this phase 3 trial, researchers set out to test Glutathione.

Excessive oxidants released by activated inflammatory cells and persisting infections are considered the main mechanism of damage of respiratory epithelium in CF.Glutathione (GSH) represents the first-line defence of the lung against oxidative stress-induced cell injury; however, a depletion of its levels has been observed in the airways of patients affected by CF.

It had two arms (groups): Physiological solution (placebo comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

150 eligible patients will be enrolled on the basis of inclusion criteria.

Patients will be divided in two groups: 1) Group 1 age between 6 and 18 years; 2) Group 2 older than 18 years.

Clinical visits will take place at the beginning (visit 0, enrolment visit) and after one month (visit 1), three months (visit 2), six months (visit 3) nine months (visit 4), and twelve months (visit 5, end of treatments).

Follow-up clinical visits will take place one month (visit 6), three months (visit 7), six months (visit 8) after the end of treatments.

Who Took Part

The registry lists 150 planned participants were the target.

It was open to people of any sex aged from 6 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female aged older than 6 years;. Stable clinical condition;. Written informed consent.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: pregnancy and fertile women taking oral contraceptives;; cigarette smoking;; positive culture for burkholderia cepacia;.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Glutathione study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Glutathione was given.

Those kept unaware of assignments: participant.

It started in 2010-06 with completion listed for 2012-05.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Forced expiratory volume in one second (FEV1) percent (time frame: 12 months).

It also tracked 9 secondary outcomes, for example Small airway function, Exercise Capacity, BMI, Dyspnoea, Cough and Quality of life.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Glutathione in 150 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.