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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

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

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would qualify for inclusion in this clinical experiment?

"Eligibility for this clinical trial demands one have idiopathic pulmonary fibrosis and be between the ages of 40 and 80. Approximately 50 participants are necessary to complete the research project."

Answered by AI

What is the overall patient participation rate in this medical experiment?

"That is accurate. According to clinicaltrials.gov, this particular medical trial was initially posted on August 15th 2023 and recently updated on September 16th 2023. The study requires 50 individuals from just one site in order for the research to be successful."

Answered by AI

Are there vacancies still available in this clinical exploration?

"This research study, which was first uploaded to clinicaltrials.gov on the 15th of August 2023, is currently looking for participants. The protocol was last revised on 16 September 2023."

Answered by AI

Is there an age restriction for enrolment in this research project?

"This clinical trial's enrollment specifications stipulate that participants must range between 40 and 80 years old."

Answered by AI

Is the inhalation of 20mM sodium pyruvate a hazardous procedure for individuals?

"Based on the Phase 3 trial data, our team assessed that 20mM sodium pyruvate nasal spray is safe and rated it a 3. There is solid evidence suggesting its efficacy as well as multiple rounds of safety studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of N115 on Coughing in IPF Patients

2023. "The Effect of N115 on Coughing in IPF Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06037408.

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