CLINICAL TRIAL

Ipratropium Bromide for Dyspnea

Waitlist Available · < 18 · All Sexes · Columbus, OH

This study is evaluating whether a specific breathing technique may help reduce the frequency of asthma attacks in obese children.

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About the trial for Dyspnea

Eligible Conditions
Obesity · Dyspnea; Asthmatic · Obesity, Childhood · Dyspnea · Asthma · Asthma in Children · Pediatric Obesity

Treatment Groups

This trial involves 2 different treatments. Ipratropium Bromide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Albuterol
DRUG
Ipratropium Bromide
DRUG
Control
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Salbutamol
FDA approved
Ipratropium
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have a minimum age of 9 years.\n show original
Participants with physician diagnosed asthma and on regular asthma controller therapy for at least 8 weeks prior to enrollment will be recruited for this study.
Objectively Confirmed Asthma Diagnosis: Asthma diagnosis will be confirmed objectively using spirometry (FEV1 < 80% predicted or FEV1/FVC < lower limit of normal), bronchodilator reversibility testing (post-bronchodilator improvement of ≥ 12% and 200mL in FEV1 or FVC; or a decrease in lung hyperinflation of at least 150 mL; ATS guidelines on lung function test interpretation), or a methacholine challenge test. Patients in whom asthma cannot be confirmed objectively will be excluded from the study.
Experience dyspnea on exertion as assessed by answering "yes" to one of the following two questions on the screening questionnaire: 1) Do you get short of breath with exertion? 2) Do you feel that your asthma is limiting you from participating in exercise?
Ability to communicate in English
Nonobese: BMI 5th-84th percentile based on norms from the Centers for Disease Control (CDC)
Obese: BMI ≥95th percentile and less than 170% of the 95th BMI percentile based on norms from the CDC
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: During the intervention (exercise)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: During the intervention (exercise).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ipratropium Bromide will improve 4 primary outcomes and 1 secondary outcome in patients with Dyspnea. Measurement will happen over the course of During the intervention (exercise).

Expiratory flow limitation
DURING THE INTERVENTION (EXERCISE)
Units: % of tidal volume, measured as overlap between exercise tidal flow volume loop and maximal expiratory flow volume loop
Forced expiratory volume in 1 s
DURING THE INTERVENTION (EXERCISE)
Units: Litres, measured with spirometry
Closing capacity
DURING THE INTERVENTION (EXERCISE)
Units: % of total lung capacity, measured using single breath nitrogen washout
Dynamic hyperinflation
DURING THE INTERVENTION (EXERCISE)
Units: % of total lung capacity, measured as change in end-expiratory lung volume from rest to exercise
Rating of perceived breathlessness
DURING THE INTERVENTION (EXERCISE)
Borg 0 - 10 scale

Who is running the study

Principal Investigator
D. B.
Prof. Dharini Bhammar, Assistant Professor
Ohio State University

Patient Q & A Section

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

What are the latest developments in ipratropium bromide for therapeutic use?

Ipratropium bromide is a well-tolerated anti-cholinergic agent used for the management of the symptoms of chronic airway obstruction. This agent may provide a valuable therapeutic alternative for treating chronic obstructive lung disease in patients who are intolerant or unwilling to take more dangerous antihistaminic medications. The combination of ipratropium bromide with salbutamol or budesonide has no additional benefit compared with salbutamol alone.

Anonymous Patient Answer

What are the signs of dyspnea?

Signs of dyspnea include shortness of breath, which is usually a result of increased work of breathing, reduced breath sounds in a part of the lungs usually involved in the disease, and increased jugular venous distension with elevated jugular venous pressure. These presentations are generally consistent with chronic inflammation, particularly in the most vigorous of patients because chronic inflammation in the lung involves the lung's parenchyma and bronchial tree. These signs are best evaluated with a detailed physical examination by a health care professional, including a careful examination of respiratory sounds by a physician trained in the field. A respiratory exam, even by an observer in training, is useful in assessing chronic respiratory problems.

Anonymous Patient Answer

How many people get dyspnea a year in the United States?

Approximately 1.9 million people in the United States have dyspnea every year. However, only 39% of the dyspnea cases are reported to a health professional. There are significant barriers to seeking treatment, including lack of understanding of symptoms, cost of treatment, and lack of provider experience in treating symptoms of dyspnea.

Anonymous Patient Answer

What causes dyspnea?

Dyspnea is a symptom of many pulmonary conditions such as pneumoconiosis, obstructive lung disease, cancer (most commonly NSCLC) or fibrosing alveolitis; and it is a common comorbidity in people with COPD. The underlying mechanism of airflow limitation is probably multifactorial but the most important mechanisms are dysregulated bronchoconstriction, hyperinflation, impaired elastic recoil, and changes in elastic properties in the lungs. While many diseases cause dyspnea, some causes are not addressed by the current diagnostic and treatment guidelines; such as in patients with an abnormal radiology or CT and a benign lung disease.

Anonymous Patient Answer

Can dyspnea be cured?

Dyspnea is difficult to treat but can be improved by regular physical activity, breathing techniques, and use of bronchodilators. Patients who have persistent dyspnea may benefit from nonpharmacological treatment. Future studies should address whether these conclusions are applicable to other patient populations.

Anonymous Patient Answer

What are common treatments for dyspnea?

There are a few common treatments for dyspnea (bronchodilators, diuretics, and oxygen). More comprehensive treatment may improve quality of life and quality of life-related patient-reported outcomes.

Anonymous Patient Answer

What is dyspnea?

Dyspnea can be described as unpleasant breathing. People with dyspnea have breathlessness that is accompanied by unpleasant sensations in respiration as well as with sensations of the chest. Dyspnea affects about 200 million persons worldwide every year, while the number of actual deaths due to it is between 1.2 and 21.7 times higher at 1.5 million per year each. Subjective and objective assessment of dyspnea can be useful in understanding the prognosis and treating the disease.

Anonymous Patient Answer

Does ipratropium bromide improve quality of life for those with dyspnea?

Ipratropium bromide improves subjective, physical, and mental component scores of HRQL. HRQL improvement is a substantial burden on patients with significant chronic dyspnea whose function is significantly impaired.

Anonymous Patient Answer

Is ipratropium bromide typically used in combination with any other treatments?

IP-16 is typically used used in combination with bronchodilators and inhaled corticosteroids. It is more commonly used in conjunction with inhaled corticosteroids than with bronchodilators in recent clinical trials.

Anonymous Patient Answer

What is the primary cause of dyspnea?

Primary causes of dyspnea may be grouped into [1] pulmonary conditions, [2] pulmonary complaints, or [3] nonpulmonary complaints. These conditions can affect [4] any organ system, [5] more than another, and [6] vary from patient to patient. The most common causes of dyspnea are not necessarily the primary causes of dyspnea. Pulmonary disorders and nonpulmonary complaints are more common causes of dyspnea than pulmonary complaints in older adults.

Anonymous Patient Answer

What is the average age someone gets dyspnea?

Dyspnea is one of the common symptoms of COPD. It is more common in the elderly. The exact causes are still unknown. However, there is no clear evidence to prove whether the dyspnea is a cause of the COPD or the COPD cause it. [The cause of dyspnea in the elderly is likely related to various other lung conditions, like cancer or interstitial lung disease. Dyspnea should not be used as an argument for not prescribing COPD therapies due to concern with possible toxicity (for instance, lung cancer or interstitial lung disease) in the elderly.

Anonymous Patient Answer

What is the latest research for dyspnea?

The lack of evidence in research literature indicates that the evidence is not only needed, but also it can provide guidance to clinicians to enhance their practice and ensure a high standard of care.

Anonymous Patient Answer
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