Water Spray for Elderly with COPD

Overseen By Taysom Wallace, MS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Heart disease, Cancer, Diabetes, others

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

Compensation: Varies

Number of Visits: 4

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people with chronic conditions that require regular medication.

Is water spray safe for elderly people with COPD?

The research articles reviewed do not provide specific safety data on water spray for elderly people with COPD. However, in a study involving placebo inhalers, adverse events were low, with the most common being headaches and coughs, suggesting that similar interventions might be generally safe. ^{1 2 3 4 5}

How does the water spray treatment for COPD differ from other treatments?

The water spray treatment for elderly patients with COPD is unique because it involves using a simple, non-drug method (water spray) as a placebo or standard care, which contrasts with typical COPD treatments that often involve medications like inhaled steroids or beta-agonists. ^{2 4 6 7 8}

What is the purpose of this trial?

The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD.

Eligibility Criteria

Inclusion Criteria

I am 65 years old or older.

I have been diagnosed with COPD.

Exclusion Criteria

My BMI is 31 or higher.

I have a known heart condition.

Current smokers

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Very hot and dry exposure

Subjects will be exposed to 3 hours in a climate chamber set to approximately 47 deg C and 15% relative humidity, with one visit including water spray for cooling

1 day

2 visits (in-person)

Hot and humid exposure

Subjects will be exposed to 3 hours in a climate chamber set to approximately 41 deg C and 40% relative humidity, with one visit including water spray for cooling

1 day

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Control
• Water Spray

Participant Groups

Group I: Experimental: Very hot and dry Experimental Treatment 2 Interventions

Subjects will be exposed to 3 hours in a climate chamber set to approximately 47 deg C and 15% relative humidity, which reflects a very hot and dry heat wave condition similar to the 2018 Los Angeles heat wave. Two visits will be required to complete this arm, with one visit including water spray for cooling.

Group II: Experimental: Hot and humid Experimental Treatment 2 Interventions

Subjects will be exposed to 3 hours in a climate chamber set to approximately 41 deg C and 40% relative humidity, which reflects hot and humid heat wave similar to the 1995 Chicago heat wave. Two visits will be required to complete this arm, with one visit including water spray for cooling.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

The Salford Lung Study (SLS) revealed that patients with COPD in real-world settings are older, have more comorbidities, and experience more frequent exacerbations compared to those in traditional efficacy trials, highlighting a gap in representativeness.

Only about 30% of SLS patients would qualify for inclusion in standard efficacy trials, suggesting that results from these trials may not fully apply to the broader COPD population seen in everyday clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness versus efficacy trials in COPD: how study design influences outcomes and applicability. Woodcock, A., Boucot, I., Leather, DA., et al.[2022]

In the UPLIFT trial, patients assigned to the placebo group had a significantly higher rate of premature discontinuation (45%) compared to those receiving tiotropium (37%), indicating that treatment assignment impacts trial completion rates.

Patients who discontinued were generally more severe in their COPD symptoms, had worse lung function (lower FEV1), and poorer health-related quality of life, suggesting that these factors contribute to higher dropout rates in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Premature discontinuation during the UPLIFT study. Decramer, M., Molenberghs, G., Liu, D., et al.[2015]

A multicenter single-blinded randomized controlled trial is being conducted to evaluate the effectiveness of a placebo-device training program for inhaler education in patients over 65 with asthma or COPD, aiming to reduce exacerbation rates over a 1-year follow-up period.

The study will involve 146 participants and assess not only exacerbation rates but also quality of life, adherence, clinical control, and respiratory function, providing a comprehensive look at the impact of inhaler training on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhaler technique education in elderly patients with asthma or COPD: impact on disease exacerbations-a protocol for a single-blinded randomised controlled trial. Maricoto, T., Correia-de-Sousa, J., Taborda-Barata, L.[2020]

In a study involving 53 patients with chronic obstructive pulmonary disease (COPD), regular use of short-acting inhaled beta-agonists like albuterol did not provide any significant physiological or clinical benefits compared to using them as needed.

Despite patients using twice as much albuterol during the regular treatment period, there were no meaningful differences in lung function or quality of life measures, indicating that regular beta-agonist therapy may not be beneficial for COPD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regular versus as-needed short-acting inhaled beta-agonist therapy for chronic obstructive pulmonary disease. Cook, D., Guyatt, G., Wong, E., et al.[2013]

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]

In a three-year study involving 290 patients with chronic obstructive pulmonary disease (COPD), inhaled budesonide did not significantly reduce the decline in lung function compared to placebo, with an insignificant difference of only 3.1 ml/year in FEV1 decline.

Budesonide also showed no effect on respiratory symptoms or the frequency of exacerbations, raising questions about the effectiveness of long-term inhaled corticosteroids for treating mild to moderate COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term effect of inhaled budesonide in patients with mild to moderate chronic obstructive lung disease. The Osterbro Study]. Vestbo, J., Sørensen, T., Lange, P., et al.[2006]

In elderly patients with severe irreversible airway obstruction, stopping inhaled corticosteroid therapy led to a decline in lung function, as indicated by a significant decrease in FEV1 during the placebo period compared to baseline.

The study suggests that inhaled corticosteroids like beclomethasone dipropionate (BDP) are important for maintaining respiratory function and reducing exercise-induced breathlessness in this patient population, as evidenced by improved dyspnea scores during BDP treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of withdrawal of inhaled steroids in men with severe irreversible airflow obstruction. O'Brien, A., Russo-Magno, P., Karki, A., et al.[2013]

In a study involving 281 COPD patients, fluticasone propionate significantly reduced the severity of exacerbations compared to placebo, with 60% of patients experiencing moderate or severe exacerbations versus 86% in the placebo group (p<0.001).

Patients treated with fluticasone propionate showed significant improvements in lung function and symptoms, including increased peak expiratory flow and a greater 6-minute walking distance, while the treatment was well-tolerated with minimal adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. Paggiaro, PL., Dahle, R., Bakran, I., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness versus efficacy trials in COPD: how study design influences outcomes and applicability. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Premature discontinuation during the UPLIFT study. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Inhaler technique education in elderly patients with asthma or COPD: impact on disease exacerbations-a protocol for a single-blinded randomised controlled trial. [2020]

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

Regular versus as-needed short-acting inhaled beta-agonist therapy for chronic obstructive pulmonary disease. [2013]

5. 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]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Long-term effect of inhaled budesonide in patients with mild to moderate chronic obstructive lung disease. The Osterbro Study]. [2006]

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

Effects of withdrawal of inhaled steroids in men with severe irreversible airflow obstruction. [2013]

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

Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. [2022]