Metformin for Chronic Obstructive Pulmonary Disease

(INSPIRE-COPD-E Trial)

Overseen By Jessica Shier

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: Duke University

Must not be taking: Metformin, Carbonic Anhydrase Inhibitors

Disqualifiers: Diabetes, Hepatic impairment, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety of using Metformin, a common diabetes medication, for individuals with chronic obstructive pulmonary disease (COPD). The researchers aim to determine if Metformin can alter blood markers related to aging in these patients. Suitable candidates for this trial have a long-standing history of COPD, heavy smoking, and frequent flare-ups requiring medical attention. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants an opportunity to contribute to groundbreaking research.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be actively treated with metformin or Carbonic Anhydrase Inhibitors like topiramate or acetazolamide.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that Metformin, a common diabetes drug, is generally safe. Studies indicate it can reduce hospital visits and deaths in people with both diabetes and COPD. For COPD patients without diabetes, its safety remains under study, but it is usually well-tolerated. Metformin is known to be safe and affordable, though there is a rare risk of lactic acidosis, a buildup of acid in the blood. This risk introduces some uncertainty regarding its safety in COPD, but past use in similar patients is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Metformin for Chronic Obstructive Pulmonary Disease (COPD) because it represents a novel approach beyond the traditional treatments like bronchodilators and steroids. Metformin, commonly used for diabetes, is being explored for its potential anti-inflammatory effects in the lungs of COPD patients without diabetes. This unique mechanism could offer a new pathway to manage inflammation in COPD, which is a key factor in the disease's progression. If successful, Metformin could provide a dual benefit by reducing inflammation and potentially improving overall lung function, offering hope for better management of COPD symptoms.

What evidence suggests that Metformin might be an effective treatment for COPD?

Research has shown that metformin may benefit people with chronic obstructive pulmonary disease (COPD). Studies suggest that metformin can reduce the risk of hospital visits related to COPD and lower the chance of dying from any cause. One study found that metformin increased breathing muscle strength by 11% in patients with moderate to severe COPD, indicating it might help improve breathing. Although most studies involved people with both COPD and diabetes, they offer hope that metformin could also benefit those with only COPD. In this trial, participants will receive metformin to evaluate its effects specifically in COPD patients without diabetes. ^{5 6 7 8 9}

Who Is on the Research Team?

Christopher Mosher, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older with COPD, defined by specific breathing test results and a history of smoking. Participants must have had frequent lung flare-ups but cannot have diabetes, metformin allergy, severe liver issues, cognitive impairments like dementia, recent unstable medical conditions, certain heart failures, or be on drugs that affect body acids.

Inclusion Criteria

History of COPD defined by spirometry demonstrating FEV1/FVC < 70%

10 or more tobacco pack year history

I've had at least one severe or two moderate COPD flare-ups in the last year.

Exclusion Criteria

Metformin allergy

I have diabetes or am currently being treated with metformin.

I have a disability that prevents me from visiting the clinic in person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Metformin to assess safety, tolerability, and changes in blood markers associated with aging

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Metformin

Trial Overview

The study tests the safety and effects of Metformin on aging-related blood markers in non-diabetic COPD patients. It aims to see if this common diabetes drug can help with lung health by reducing signs of aging in the blood.

How Is the Trial Designed?

Group I: Metformin Experimental Treatment 1 Intervention

Metformin in COPD patients without diabetes

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9441545/

Cardiovascular outcomes of metformin use in patients with ...

Conclusion: In patients with coexisting T2DM and COPD, metformin use was associated with significantly lower risks of CVD; moreover, longer ...

2.

nature.com

nature.com/articles/s41598-020-67338-2

Respiratory outcomes of metformin use in patients with ...

This nationwide cohort study demonstrated that in patients with T2DM and COPD, metformin use was associated with higher risks of pneumonia, hospitalization for ...

3.

ec.bioscientifica.com

ec.bioscientifica.com/view/journals/ec/11/9/EC-22-0289.xml

Effects and safety of metformin in patients with concurrent ...

Metformin use is associated with lower risk of COPD-related hospitalizations and risk of all-cause mortality without increasing the risk of hyperlactatemia.

4.

ajmc.com

ajmc.com/view/metformin-may-lower-risk-of-hospitalization-mortality-in-concurrent-copd-diabetes

Metformin May Lower Risk of Hospitalization, Mortality in ...

A previous prospective study found that metformin increased inspiratory muscle strength by 11% in patients with moderate to severe COPD after 6 ...

5.

jtd.amegroups.org

jtd.amegroups.org/article/view/32449/html

Role of metformin in treatment of patients with chronic ...

We included a total of six articles (involving 3,467 participants) and found that metformin may benefit patients with COPD and T2DM by improving ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9422254/

Effects and safety of metformin in patients with concurrent ...

Metformin was associated with lower risk of COPD-related hospitalizations (RR: 0.72, 95% CI: 0.53–0.98; I2= 89%) and all-cause mortality (RR: 0.60, 95% CI: 0.36 ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03651895

Metformin to Reduce Airway Glucose in COPD Patients

Metformin is safe and cheap, and has been extensively used in COPD patients with diabetes with an excellent safety record. The primary aim of this study will ...

8.

tandfonline.com

tandfonline.com/doi/full/10.3109/15412555.2014.898052

Safety of Metformin in Patients with Chronic Obstructive ...

However, due to its rare association with lactic acidosis, its safety in COPD is uncertain.

9.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0204859

Effects of metformin use on total mortality in patients with type ...

Metformin users had significantly lower risk of noncardiovascular death (aHR = 0.86, p = 0.0008). A total of 7721 metformin users were matched ...