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Sodium Pyruvate Nasal Spray for Idiopathic Pulmonary Fibrosis

Phase 3
Recruiting
Led By Manuel M Lam, MD
Research Sponsored by Cellular Sciences, inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Condition-related cough
Individuals with a clinical diagnosis of idiopathic pulmonary fibrosis in accordance with the most recent collaborative guidelines from the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society, and the Latin American Thoracic Association including HRCT scan and/or lung biopsy consistent with unusual interstitial pneumonia (UIP), especially honeycombing, without identifiable cause related to other ILD such as drug toxicity, occupational or environmental exposure or connective tissue disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights

Study Summary

This trial will test a nasal spray to reduce coughing and improve lung function in patients with idiopathic pulmonary fibrosis. Results will be measured over 21 days in a double-blind, placebo-controlled trial.

Who is the study for?
This trial is for adults with idiopathic pulmonary fibrosis who have a mild to moderate lung function (FEV1 and FVC at 50% or greater), are not pregnant, do not have other significant health issues like heart disease or metabolic diseases, haven't been hospitalized recently for airway disease, and aren't using certain medications. Participants must use contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial tests whether a nasal spray containing sodium pyruvate can reduce coughing and improve lung function in patients with idiopathic pulmonary fibrosis over 21 days. It's a double-blind study where half the participants will receive the actual drug and the other half will get a saline placebo without knowing which one they received.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include irritation or discomfort in the nose from the nasal spray application. Since it's a test for efficacy on coughing and lung function, monitoring for any respiratory changes is also expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a cough related to my health condition.
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I have been diagnosed with a specific lung condition without a known cause, confirmed by special lung scans or biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Coughing
Secondary outcome measures
FEV1/FVC ratios

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 20mM sodium pyruvate nasal spray treatmentExperimental Treatment1 Intervention
Group II: Saline placebo controlPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Family First Medical Research CenterUNKNOWN
2 Previous Clinical Trials
52 Total Patients Enrolled
Cellular Sciences, inc.Lead Sponsor
5 Previous Clinical Trials
197 Total Patients Enrolled
Manuel M Lam, MDPrincipal InvestigatorFamily First Medical Research Center
~8 spots leftby Aug 2024
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