NCT03020719: GROW

The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis

Completed Phase 2 Results posted Last updated 9 January 2020

What this trial tests

Phase 2 trial testing Oral Glutathione in Cystic Fibrosis in 60 participants. Completed in 12 December 2018.

Timeline

14 June 2017

Primary endpoint
12 December 2018

12 December 2018

Quick facts

Lead sponsor	University of Minnesota
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	60
Start date	14 June 2017
Primary completion	12 December 2018
Estimated completion	12 December 2018
Sites	18 locations across United States

Drugs / interventions tested

• Oral Glutathione — full drug profile →
• Placebo

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

University of Minnesota

Who can join

Adults 2 to 11, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Weight-for-age Z-score Primary · Baseline to 24 weeks

Difference between the oral glutathione and placebo groups in the 24-week change from baseline in weight-for-age Z-score. Weight-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than

Group	Value	95% CI
Oral Glutathione	-0.018	-0.124 – 0.087
Placebo	0.045	-0.073 – 0.163

Change in Height-for-age Z-score Secondary · Baseline to 24 weeks

Difference between the oral glutathione and placebo groups in the 24-week change from baseline in height-for-age Z-score. Height-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than

Group	Value	95% CI
Oral Glutathione	-0.04	± 0.21
Placebo	0.03	± 0.16

Change in BMI-for-age Z-score Secondary · Baseline to 24 weeks

Difference between the oral glutathione and placebo groups in the 24-week change from baseline in BMI-for-age Z-score. BMI-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the m

Group	Value	95% CI
Oral Glutathione	-0.01	± 0.48
Placebo	0.04	± 0.44

Change in Fecal Calprotectin Secondary · Baseline to 24 weeks

Difference between the oral glutathione and placebo groups in the 24-week change from baseline in fecal calprotectin.

Group	Value	95% CI
Oral Glutathione	0.05	± 0.55
Placebo	-0.05	± 0.53

Change in High-sensitivity C-reactive Protein (Hs-CRP) Secondary · Baseline to 24 weeks

Difference between the oral glutathione and placebo groups in the 24-week change from baseline in hs-CRP.

Group	Value	95% CI
Oral Glutathione	-0.45	± 3.4
Placebo	-0.04	± 1.6

Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · Baseline to 24 weeks

The number and percentage of participants with at least one event over the 24 week follow-up period.

Adverse Events

Group	Value	95% CI
Oral Glutathione	29
Placebo	29

Serious Adverse Events

Group	Value	95% CI
Oral Glutathione	1
Placebo	5

Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · Baseline to 24 weeks

Rate is defined as the number of events per participant follow-up month.

Adverse Events

Group	Value	95% CI
Oral Glutathione	0.89
Placebo	0.74

Serious Adverse Events

Group	Value	95% CI
Oral Glutathione	0.01
Placebo	0.05

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oral Glutathione

Serious: 1/30 (3%)

Deaths: 0/30

Placebo

Serious: 5/30 (17%)

Deaths: 0/30

Serious adverse events (6 terms)

Reaction	System	Oral Glutathione	Placebo
Infective pulmonary exacerbation of cystic fibrosis	Respiratory, thoracic and mediastinal disorders	—	—
Distal intestinal obstruction syndrome	Gastrointestinal disorders	—	—
Cellulitis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Weight decreased	Investigations	—	—
Failure to thrive	Metabolism and nutrition disorders	—	—

Other adverse events (28 terms — click to expand)

Reaction	System	Oral Glutathione	Placebo
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Infective pulmonary exacerbation of cystic fibrosis	Respiratory, thoracic and mediastinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Otitis media	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Weight decreased	Investigations	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Steatorrhoea	Gastrointestinal disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Alanine aminotransferase increased	Investigations	—	—
Pulmonary function test decreased	Investigations	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Clubbing	Musculoskeletal and connective tissue disorders	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Infective pulmonary exacerbation of cystic fibrosis, Distal intestinal obstruction syndrome, Cellulitis, Pneumonia, Weight decreased, Failure to thrive.

Data from ClinicalTrials.gov NCT03020719 adverse events section.

Sponsor's own description

The purpose of this randomized, placebo-controlled (Phase II) study will be to further evaluate the effects of oral glutathione on growth in children with CF.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Insights on Localized and Systemic Delivery of Redox-Based Therapeutics.
   Buglak NE, Batrakova EV, Mota R, Bahnson ESM. · · 2018 · cited 9× · PMID 29636836 · DOI 10.1155/2018/2468457
2. Oral Glutathione and Growth in Cystic Fibrosis: A Multicenter, Randomized, Placebo-controlled, Double-blind Trial.
   Bozic M, Goss CH, Tirouvanziam RM, Baines A, et al · · 2020 · cited 7× · PMID 32960827 · DOI 10.1097/mpg.0000000000002948