Albuterol for LAM
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
No Placebo Group
Trial Summary
What is the purpose of this trial?Background:
- Lymphangioleiomyomatosis (LAM) is a rare type of lung disease that occurs almost exclusively in women. In LAM, muscle tissue grows in the lungs and starts to block the flow of air. It is a progressive disease, and in severe cases may require a lung transplant. One possible treatment to improve breathing in people with LAM is inhaled albuterol. Albuterol can be given in a metered dose inhaler (MDI) or with a nebulizer. Researchers want to compare these methods to see which method best improves lung function in women with LAM.
Objectives:
- To see whether a nebulizer or MDI can better improve lung function in women with LAM.
Eligibility:
- Women at least 18 years of age who have impaired lung function because of LAM.
Design:
* Participants will be screened with a physical exam and medical history. No lab tests will be needed for this study.
* Participants will have a 3-day overnight stay at the National Institutes of Health. Those who are using long-acting inhalers will have to stop taking these drugs 1 week before the study.
* Participants will receive either the nebulizer or two or four puffs of the inhaler. Four puffs of albuterol is a higher dose than is normally prescribed, and is being tested on this study.
* Participants will have each treatment around the same time of day on each of the 3 days. Before and after taking the albuterol, participants will have lung function tests.
What data supports the idea that Albuterol for LAM is an effective drug?
The available research shows that Albuterol, known by various brand names like Proventil HFA and Ventolin, is effective in providing bronchodilation, which means it helps open up the airways in the lungs. This is demonstrated in studies where Albuterol was compared to other treatments for asthma, showing similar effectiveness in improving breathing over 12 weeks. Although the studies focus on asthma, they suggest that Albuterol can effectively improve lung function, which may be beneficial for conditions like LAM. However, there is no specific data provided for LAM in the available research.
23568What safety data exists for Albuterol treatments?
The safety of Albuterol treatments, including Proventil HFA and Ventolin, has been evaluated in several studies. One study found that Proventil HFA and Ventolin have similar safety profiles during regular use over 12 weeks. Another study compared HFA 134a salbutamol sulfate with CFC salbutamol and found no significant differences in safety, including pulse rate, blood pressure, and ECG intervals. Patients switched from CFC to HFA albuterol showed comparable safety and efficacy, with similar adverse event profiles, except for increased asthma symptoms and rhinitis in the CFC group. Overall, HFA albuterol formulations are considered safe and effective alternatives to CFC formulations.
13457Do I need to stop my current medications for the trial?
If you are using long-acting inhalers, you must stop taking them 1 week before the study. Also, if you are on monoamine oxidase inhibitors, tricyclic antidepressants, beta-adrenergic receptor antagonists, or long-acting anticholinergic bronchodilators, you need to discontinue them at least 7 days before enrollment.
Eligibility Criteria
This trial is for women over 18 with Lymphangioleiomyomatosis (LAM), a rare lung disease. They must have specific lung function impairments and may have a diagnosis based on tissue biopsy, organ involvement, or high VGEF-D levels. Excluded are those post-transplant, allergic to albuterol, with certain health conditions like seizures or major systemic diseases, pregnant/breastfeeding women, and those unable to stop certain medications before the study.Inclusion Criteria
I am 18 years old or older.
Exclusion Criteria
I do not have severe thyroid issues, uncontrolled GERD, or major diseases like cancer or severe diabetes.
I have difficulty with memory or thinking clearly.
I have had seizures, but not only when I was a baby.
I am male.
I am under 18 years old.
I have had a lung or kidney transplant.
I have a moderate or large amount of fluid in my chest.
Participant Groups
The trial aims to compare two methods of delivering albuterol—a medication that helps open airways—to see which improves lung function in LAM patients better: an inhaler (MDI) or a nebulizer. Participants will stay overnight for three days at NIH and receive either treatment while their lung function is tested before and after administration.
2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment2 Interventions
Nebullizer
Group II: 2Active Control2 Interventions
Inhaler
Albuterol Inhaler is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Albuterol for:
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Exercise-induced bronchospasm
🇪🇺 Approved in European Union as Salbutamol for:
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Exercise-induced bronchospasm
🇨🇦 Approved in Canada as Albuterol for:
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Exercise-induced bronchospasm
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, MD
National Institutes of Health Clinical CenterBethesda, MD
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
References
Cumulative dose-response study of non-CFC propellant HFA 134a salbutamol sulfate metered-dose inhaler in patients with asthma. [2019]This study compares the safety and efficacy of HFA 134a salbutamol sulfate (Airomir in the 3M CFC-free system [3M Pharmaceuticals]) and CFC 11/12 salbutamol (Ventolin [Allen & Hanburys]) in a cumulative dose-response (1, 1, 2, 4, 8 inhalations at 30-min intervals) study in asthmatic patients.
Proventil HFA provides bronchodilation comparable to ventolin over 12 weeks of regular use in asthmatics. [2021]To compare the bronchodilator effectiveness of albuterol reformulated in the chlorofluorocarbon-free propellant hydrofluoroalkane (HFA)134a (Proventil HFA) to that of Ventolin and HFA placebo over 12 weeks of regular dosing.
Proventil HFA and ventolin have similar safety profiles during regular use. [2019]As a secondary objective to a long-term study evaluating the bronchodilator effectiveness of Proventil HFA (albuterol), to assess the safety of Proventil HFA, Ventolin, and hydrofluoroalkane 134a (HFA-134a) placebo over 12 weeks of regular dosing.
Switching patients with asthma from chlorofluorocarbon (CFC) albuterol to hydrofluoroalkane-134a (HFA) albuterol. [2016]Chlorofluorocarbon (CFC) propellants deplete stratospheric ozone. Production and use of CFCs, except for certain critical exemptions, has been prohibited by the Montreal Protocol. Use of CFCs as propellants in metered-dose inhalers (MDIs) is still allowed, but the U.S. Food and Drug Administration is planning the transition to alternative propellants for use in MDIs. Hydrofluoroalkane-134a (HFA), a non-ozone-depleting propellant, has been used to reformulate albuterol (HFA albuterol). This study evaluates whether comparable safety and efficacy continues for 12 weeks after patients with asthma are switched from CFC albuterol to HFA albuterol. Patients with asthma stabilized on CFC albuterol during a 12-week safety and efficacy trial were randomized to either continue receiving CFC albuterol or to be switched to receive HFA albuterol in a yearlong safety and efficacy trial. Safety and efficacy were compared over the first 12 weeks of the yearlong trial between patients who had remained on CFC albuterol and those who had been switched to HFA albuterol. Bronchodilator efficacy was evaluated by serial spirometry for 6 hr after the patients self-administered the study drug in the clinic. Safety was assessed by measuring changes in pulse rate, blood pressure, and electrocardiogram (ECG) intervals after dosing with study drug, monitoring adverse events, and performing prestudy and poststudy laboratory testing and physical examinations. No significant differences in bronchodilator efficacy between the patients continuing to receive CFC albuterol and those switched to HFA albuterol were found in the 12 weeks after the switch. No differences between the two products were found for changes in pulse rate, blood pressure, and ECG intervals. Adverse event profiles were similar for the two products, except the patients remaining on CFC albuterol reported increased asthma symptoms and rhinitis significantly more often than the patients switched to HFA albuterol. No clinically meaningful changes in laboratory tests or physical examinations were found in either treatment group. Patients with asthma switched from CFC albuterol to HFA albuterol receive comparable bronchodilation with a similar safety profile as those continuing to receive CFC albuterol.
Comparison of the bronchodilating effects of formoterol and albuterol delivered by hydrofluoroalkane pressurized metered-dose inhaler. [2019]To compare the onset of bronchodilation with a new formoterol hydrofluoroalkane (HFA) pressurized metered-dose inhaler (pMDI) with albuterol (salbutamol) HFA pMDI.
Bronchoprotective and bronchodilator effects of an HFA pMDI vs. a CFC pMDI and a DPI containing formoterol in asthma patients. [2015]In this double-blind, placebo-controlled, crossover study we compared the bronchoprotective effects of formoterol 12 microg inhaled via an HFA-134a inhaler (Modulite HFA) versus a CFC and a DPI device in 38 patients with mild-to-moderate persistent asthma. All three formoterol preparations significantly increased methacholine PD20 and FEV1 and improved small airway function parameters compared with placebo (p
Plume Characteristics of Two HFA-Driven Inhaled Corticosteroid/Long-Acting Beta2-Agonist Combination Pressurized Metered-Dose Inhalers. [2022]New inhalers propelled by hydrofluoroalkanes (HFAs) have improved plume characteristics: higher fine particle fraction, and warmer plumes with reduced force and velocity. Together, this may avoid reflex interruption of inhalation and improve lung deposition of the inhaled drugs. However, even with HFA-propelled pressurized metered-dose inhalers (pMDIs), there are notable differences in device properties. Here we compared the duration, velocity, force, and temperature of two inhaled corticosteroid/long-acting β2-agonist combination therapies, administered via HFA pMDIs: fluticasone propionate/formoterol 125/5 µg (FP/FORM; flutiform(®)) and fluticasone propionate/salmeterol 125/25 µg (FP/SAL; Seretide(®) Evohaler(®)).
The effect of a holding chamber on albuterol metered-dose inhaler product differences. [2017]Three albuterol sulfate metered-dose inhaled (MDI) products (Ventolin HFA, Proventil HFA, and ProAir HFA) are marketed in the United States to provide the same total dose of albuterol sulfate. However, it is widely known that the fine particle dose (