Lung Master Device for Lung Conditions

Overseen By Jania Williams, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Respiratory, chronic conditions

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Investigators are studying how a device called The Lung Master device can help people breathe better. The investigational device increases the amount of air our lungs can hold, which is important for overall lung health. The Lung Master is not approved by the FDA. The study has two visits approximately one month apart. In the first visit participants will take a spirometry test, particularly forced vital capacity (FVC), to measure volume change in the lungs. Participants will take the investigational device home to use daily, either in the morning or evening. Use will be recorded in a diary. After one month, participants will return for another spirometry test. Each study visit will take about one to two hours to complete.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial excludes people with respiratory or chronic conditions, it's possible that medication use might be a factor. Please consult with the trial coordinators for more details.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial excludes people with respiratory or chronic conditions, it might imply that participants should not be on medications for such conditions.

What data supports the idea that Lung Master Device for Lung Conditions is an effective treatment?

The available research shows that pulmonary rehabilitation, which includes exercise training and other supportive measures, significantly improves symptoms like breathlessness, exercise ability, and quality of life for people with chronic lung diseases. Although the research does not specifically mention the Lung Master Device, it highlights the benefits of similar treatments in improving these outcomes. Compared to traditional rehabilitation methods, home-based programs are also effective, making it easier for more people to access these benefits. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Lung Master for lung conditions?

Pulmonary rehabilitation, which includes exercise training and education, has been shown to improve breathing difficulties, exercise capacity, and quality of life in patients with chronic lung diseases. These benefits suggest that treatments like the Lung Master, which may involve similar components, could be effective for lung conditions. ^{1 2 3 4 5}

What safety data is available for the Lung Master Device?

The safety data for the Lung Master Device, also known as the Pulmonary Exerciser, is not directly mentioned in the provided research. However, a similar device, the UL-OPEP, was evaluated for safety in a short-term pilot study with COPD patients, showing no adverse events or negative impacts on lung function, exercise tolerance, or quality of life over a one-month period. This suggests a potential safety profile for similar devices, but specific data for the Lung Master Device itself is not provided. ^{6 7 8 9 10}

Is the Lung Master Device safe for use in humans?

A study on a similar device, the UL-OPEP, found it to be safe for patients with chronic obstructive pulmonary disease (COPD) over a one-month period, with no negative effects on lung function, exercise tolerance, or quality of life. ^{6 7 8 9 10}

Is the Lung Master treatment a promising treatment for lung conditions?

The Lung Master treatment shows promise because it helps improve lung function, respiratory muscle strength, and quality of life for patients with lung conditions like COPD. It can also help patients stay active, which is important for living a longer and more productive life. ^{11 12 13 14 15}

How is the Lung Master treatment different from other treatments for lung conditions?

The Lung Master treatment is unique because it focuses on training respiratory muscles to improve lung function and quality of life, unlike other treatments that may rely on medication or oxygen supplementation. This approach is similar to using a respiratory muscle trainer, which aims to strengthen breathing muscles and reduce symptoms like breathlessness. ^{11 12 13 14 15}

Research Team

Farahnaz Fallah Tafti, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for individuals with breathing difficulties due to conditions like Asthma or COPD. Participants should be able to attend two study visits one month apart and use the Lung Master device daily, recording their usage in a diary.

Inclusion Criteria

I am either between 19-35 years old or older than 65.

I can do daily study tasks at home.

Exclusion Criteria

I have a history of lung or chronic diseases.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Lung Master device daily at home for one month, with use recorded in a diary. Spirometry tests are conducted at the beginning and end of the treatment period.

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lung Master

Trial Overview The trial is testing the Lung Master, an investigational device designed to increase lung capacity. It involves initial and follow-up spirometry tests one month apart to measure changes in lung volume after daily use of the device.

Participant Groups

Group I: Lung Function in Young and Older Adults Experimental Treatment 1 Intervention

Lung functions will be assess for two groups: young and older adults. The age range of 19 to 35 is categorized as young adulthood. This age range was selected because the lungs mature around 19-25 years old. The age range above 65 is designated as late adulthood, where lung function gradually declines.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Findings from Research

Pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD) significantly improves symptoms like shortness of breath (dyspnea), exercise capacity, and overall quality of life, as well as reducing healthcare resource use.

The effectiveness of exercise training during rehabilitation can be enhanced by using bronchodilators, supplemental oxygen, and noninvasive ventilatory support, allowing patients to train at higher intensities for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease. ZuWallack, RL.[2008]

Traditional outpatient pulmonary rehabilitation significantly improves symptoms like dyspnea, exercise capacity, and quality of life in stable COPD patients, and starting it during or after hospitalization can further enhance these outcomes and potentially reduce healthcare costs and mortality.

Home-based pulmonary rehabilitation is a safe and effective alternative that can increase access to care, but further research is needed to determine its impact on healthcare utilization and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There's no place like home: Integrating pulmonary rehabilitation into the home setting. Macrea, M., ZuWallack, R., Nici, L.[2019]

A 24-week pulmonary rehabilitation program significantly improved exercise capacity, muscle strength, and reduced dyspnea in patients with restrictive lung diseases, with 29 out of 31 patients completing the initial 12 weeks.

Patients showed clinically significant improvements in their 6-minute walk distance and quality of life measures after both 12 and 24 weeks, indicating that pulmonary rehabilitation is effective for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of pulmonary rehabilitation in patients with restrictive lung diseases. Salhi, B., Troosters, T., Behaegel, M., et al.[2018]

Pulmonary rehabilitation is an effective management strategy for patients with chronic obstructive pulmonary disease (COPD) and other chronic lung diseases, focusing on a multidisciplinary approach that addresses physical, emotional, and social health aspects.

Evidence shows that pulmonary rehabilitation improves symptoms, exercise tolerance, and quality of life while also reducing healthcare resource utilization, making it a valuable component of disease management plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation and COPD. Ries, AL.[2007]

Continued supervised maintenance exercise programs after pulmonary rehabilitation significantly reduce the risk of respiratory-cause hospital admissions in COPD patients, with a risk ratio of 0.62 based on data from 790 participants across eight trials.

While the evidence suggests a trend towards reduced exacerbations and mortality rates with supervised exercise, these outcomes did not reach statistical significance, indicating a need for further high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of supervised maintenance exercise following pulmonary rehabilitation on health care use: a systematic review and meta-analysis. Jenkins, AR., Gowler, H., Curtis, F., et al.[2018]

The prototype disposable OPEP device, UL-OPEP, was found to be safe for use in patients with COPD over a 1-month period, with no adverse events or negative impacts on lung function, exercise tolerance, or quality of life reported.

User feedback on the UL-OPEP device was generally positive, indicating a favorable user experience, although further research with larger and longer studies is needed to assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial evaluation of the safety of a disposable oscillating positive expiratory pressure device in patients with chronic obstructive pulmonary disease: a sort-term pilot study. O'Sullivan, KJ., Power, V., Linnane, B., et al.[2022]

In a 4-week study involving 66 adults with COPD, the new Jet spacer device for administering beclomethasone dipropionate showed better improvements in lung function and symptoms compared to a standard actuator, with significant differences in forced expiratory volume and bronchial noises.

The Jet spacer was also reported to be easier to use and resulted in fewer local adverse reactions, highlighting its potential as a more effective delivery method for inhaled corticosteroids in COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaled beclomethasone dipropionate administered through a new spacer device: a controlled clinical study. Vecchiet, L., Pieralisi, G., Ambrosi, L., et al.[2013]

In a study involving patients with COPD and asthma, those using the ELLIPTA inhaler made significantly fewer critical errors in inhaler technique compared to other devices like DISKUS, MDI, and Turbuhaler, indicating better usability.

A majority of patients (57-70%) using ELLIPTA did not require additional instruction for proper use, while higher percentages of patients using other inhalers needed guidance, suggesting that ELLIPTA may enhance medication delivery and patient adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices. van der Palen, J., Thomas, M., Chrystyn, H., et al.[2022]

Inhaler device errors are prevalent among patients with asthma and COPD, with overall error rates ranging from 50-100% and critical error rates between 14-92%, indicating a significant issue that can affect drug effectiveness.

The review highlights a lack of standardized checklists for assessing inhaler use, suggesting that developing these tools is essential for improving research consistency and understanding the clinical implications of inhaler misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device errors in asthma and COPD: systematic literature review and meta-analysis. Chrystyn, H., van der Palen, J., Sharma, R., et al.[2018]

In a study involving 259 adults with asthma and 278 with COPD, 96% of asthma patients and 93% of COPD patients found the placebo dry powder inhaler easy to use, demonstrating high usability and correct operation after 28 days of use.

Adverse events were relatively low, with only 12% of asthma and 15% of COPD subjects reporting any side effects, primarily headaches, indicating that the inhaler is safe for use in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correct use and ease of use of a placebo dry powder inhaler in subjects with asthma and chronic obstructive pulmonary disease. Feldman, GJ., Galkin, DV., Patel, P., et al.[2023]

A simple prototype device for training respiratory muscles showed significant improvements in lung function and quality of life in 30 COPD patients after 6 weeks of training, similar to standard training methods.

Both the prototype and standard training methods effectively reduced dyspnea scores over time, indicating that the device can be a viable clinical option for enhancing respiratory muscle strength and overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a simple prototype respiratory muscle trainer on respiratory muscle strength, quality of life and dyspnea, and oxidative stress in COPD patients: a preliminary study. Leelarungrayub, J., Pinkaew, D., Puntumetakul, R., et al.[2022]

In a study involving 19 patients with chronic obstructive pulmonary disease (COPD) and 6 healthy volunteers, patients experienced consistent underventilation and oxygen desaturation during a maximal ventilatory stress test, unlike healthy individuals.

After three weeks of training with an inspiratory resistive device, there was no significant improvement in test performance for patients, and those who showed some improvement still experienced further desaturation, indicating limited efficacy of the training method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in clinical practice. Physiologic conditioning or habituation to suffocation? Jederlinic, P., Muspratt, JA., Miller, MJ.[2019]

Patients with lung diseases like COPD can significantly improve their quality of life and longevity by staying active, especially when using portable oxygen systems.

Oxygen conserving devices have evolved to be much lighter and more portable, allowing patients to exercise more effectively, which enhances the physiological benefits of their activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen conserving devices and methodologies. Tiep, B., Carter, R.[2008]

In a study involving 59 subjects with COPD and interstitial lung disease, two oxygen-conserving devices (pulse demand oxygen delivery and pendant reservoir cannula) were found to be similarly effective as standard continuous flow nasal cannula in correcting exercise-induced hypoxemia, with 79% of COPD and 81% of ILD subjects achieving adequate oxygen saturation.

However, the pulse demand oxygen delivery system performed significantly worse in ILD patients, correcting hypoxemia in only 61% of cases, highlighting the need for personalized oxygen flow adjustments for optimal treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are oxygen-conserving devices effective for correcting exercise hypoxemia? Martí, S., Pajares, V., Morante, F., et al.[2016]

The treadmill exercise test effectively assesses exercise performance in patients with chronic lung diseases (CLD), particularly in those with chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD), by correlating maximal exercise stages with maximal oxygen uptake.

The test revealed that ventilatory limitations primarily affect COPD patients, while gas exchange and oxygen transport are more critical for ILD patients, highlighting the importance of tailored therapeutic approaches based on the specific limitations identified during exercise testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise performance and limiting factors in patients with chronic lung diseases. Kurihara, N., Fujimoto, S., Terakawa, K., et al.[2008]

References

1. United States pubmed.ncbi.nlm.nih.gov

The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease. [2008]

2. Italy pubmed.ncbi.nlm.nih.gov

There's no place like home: Integrating pulmonary rehabilitation into the home setting. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of pulmonary rehabilitation in patients with restrictive lung diseases. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation and COPD. [2007]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy of supervised maintenance exercise following pulmonary rehabilitation on health care use: a systematic review and meta-analysis. [2018]

6. England pubmed.ncbi.nlm.nih.gov

An initial evaluation of the safety of a disposable oscillating positive expiratory pressure device in patients with chronic obstructive pulmonary disease: a sort-term pilot study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Inhaled beclomethasone dipropionate administered through a new spacer device: a controlled clinical study. [2013]

8. England pubmed.ncbi.nlm.nih.gov

A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Device errors in asthma and COPD: systematic literature review and meta-analysis. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Correct use and ease of use of a placebo dry powder inhaler in subjects with asthma and chronic obstructive pulmonary disease. [2023]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of a simple prototype respiratory muscle trainer on respiratory muscle strength, quality of life and dyspnea, and oxidative stress in COPD patients: a preliminary study. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in clinical practice. Physiologic conditioning or habituation to suffocation? [2019]

13. England pubmed.ncbi.nlm.nih.gov

Oxygen conserving devices and methodologies. [2008]

14. United States pubmed.ncbi.nlm.nih.gov

Are oxygen-conserving devices effective for correcting exercise hypoxemia? [2016]

15. Japan pubmed.ncbi.nlm.nih.gov

Exercise performance and limiting factors in patients with chronic lung diseases. [2008]