Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients

What Was Tested

This registered phase 2 trial tested Glutathione.

The release of oxidants during the inflammation process leads to a chronic imbalance of oxidants and antioxidants and may be a central component leading to irreversible lung damage in CF patients.

The antioxidant glutathione, which is a naturally occurring tripeptide, is depleted in the extracellular epithelial lining fluid of the CF lung.

The registry classes the interventions as drug.

Who Took Part

153 actual participants took part.

It was open to people of any sex aged from 8 years with no upper age limit.

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

Examples of who could join: Male or female patient, 8 years (pediatric 8 - 17 years inclusive; adult 18 years). Patient is able to perform acceptable spirometric maneuvers according to ATS standards. The patient is clinically stable fulfilling the following:. Concomitant or chronic medication is planned to be continued unchanged for the entire study duration. The patient or the patient's legally acceptable representative is able to give informed consent in accordance with ICH and GCP guidelines and local legislation.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: concomitant inhaled thiol-containing medications (e.g., inhaled n-acetylcysteine); new oral or inhaled thiol-containing medications (e.g., inhaled or oral n-acetylcysteine) throughout the study period; patient with a known relevant substance abuse, including alcohol or drug abuse.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Glutathione and who got the comparison, which limits bias.

The Glutathione group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Glutathione, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2007-07 with completion listed for 2010-05.

It ran at 14 sites in Germany (14).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glutathione in 153 people.

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

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