Singulair

Asthma, Hay Fever, Asthma, Exercise-Induced + 2 more

Treatment

9 FDA approvals

20 Active Studies for Singulair

What is Singulair

Montelukast

The Generic name of this drug

Treatment Summary

Montelukast was approved by the FDA in 1998 and is a type of drug used to treat asthma. It is typically prescribed in addition to, or along with, inhaled corticosteroids. In 2008-2009, investigations were conducted into the possibility of montelukast causing neuropsychiatric effects such as agitation, hallucinations, and suicidal behavior. Although these effects are listed in the official prescribing information for montelukast, the drug is still widely used and millions of prescriptions are issued each year. It is now available as a generic and brand name product.

Singulair

is the brand name

image of different drug pills on a surface

Singulair Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Singulair

Montelukast

1998

281

Approved as Treatment by the FDA

Montelukast, otherwise called Singulair, is approved by the FDA for 9 uses such as Rhinitis, Allergic and Hay Fever .

Rhinitis, Allergic

Helps manage Perennial Allergic Rhinitis (PAR)

Hay Fever

Helps manage Seasonal Allergic Rhinitis

Asthma

Exercise-Induced Bronchospasm

Seasonal Allergic Rhinitis

Helps manage Seasonal Allergic Rhinitis

Asthma

Perennial Allergic Rhinitis (PAR)

Helps manage Perennial Allergic Rhinitis (PAR)

Disease

Helps manage inadequate response to conventional therapy

Asthma, Exercise-Induced

Effectiveness

How Singulair Affects Patients

Montelukast is a drug that blocks the leukotriene receptor in the airways, reducing inflammation and narrowing of the airways to help with asthma and allergies. It takes effect within two hours of being taken, and can be taken with a beta agonist drug for added benefit. Clinical studies have shown that taking doses higher than 10mg per day do not provide any additional benefit. Montelukast has been shown to reduce eosinophils (a type of white blood cell) by 13-15% in people with asthma, and by 13% in those with seasonal allergies.

How Singulair works in the body

Cysteinyl leukotrienes are molecules released by cells like mast cells and eosinophils. When these molecules bind to specific receptors, they can cause symptoms of asthma and allergic rhinitis like bronchoconstriction, mucus production, and inflammation. Montelukast is a drug that binds to these receptors, blocking the molecules from causing these symptoms. This helps relieve asthma and allergic rhinitis.

When to interrupt dosage

The advised measure of Singulair is contingent upon the diagnosed condition, like Exercise-Induced Bronchospasm, inadequate response to conventional therapy and Hay Fever. The dose of dosage is subject to the administration form (e.g. Tablet, chewable or Granule - Oral) featured in the table below.

Condition

Dosage

Administration

Asthma, Exercise-Induced

10.0 mg, 5.0 mg, , 4.0 mg, 0.04 mg/mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, chewable, Tablet, chewable - Oral, Tablet, Tablet - Oral, Granule, Granule - Oral, Tablet, coated, Tablet, coated - Oral

Asthma

10.0 mg, 5.0 mg, , 4.0 mg, 0.04 mg/mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, chewable, Tablet, chewable - Oral, Tablet, Tablet - Oral, Granule, Granule - Oral, Tablet, coated, Tablet, coated - Oral

Hay Fever

10.0 mg, 5.0 mg, , 4.0 mg, 0.04 mg/mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, chewable, Tablet, chewable - Oral, Tablet, Tablet - Oral, Granule, Granule - Oral, Tablet, coated, Tablet, coated - Oral

Disease

10.0 mg, 5.0 mg, , 4.0 mg, 0.04 mg/mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, chewable, Tablet, chewable - Oral, Tablet, Tablet - Oral, Granule, Granule - Oral, Tablet, coated, Tablet, coated - Oral

Rhinitis, Allergic

10.0 mg, 5.0 mg, , 4.0 mg, 0.04 mg/mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, chewable, Tablet, chewable - Oral, Tablet, Tablet - Oral, Granule, Granule - Oral, Tablet, coated, Tablet, coated - Oral

Warnings

There are 20 known major drug interactions with Singulair.

Common Singulair Drug Interactions

Drug Name

Risk Level

Description

Brigatinib

Major

The metabolism of Brigatinib can be decreased when combined with Montelukast.

Cabazitaxel

Major

The metabolism of Cabazitaxel can be decreased when combined with Montelukast.

Cyclophosphamide

Major

The metabolism of Cyclophosphamide can be decreased when combined with Montelukast.

Enasidenib

Major

The metabolism of Enasidenib can be decreased when combined with Montelukast.

Erlotinib

Major

The metabolism of Erlotinib can be decreased when combined with Montelukast.

Singulair Toxicity & Overdose Risk

Overdosing on montelukast may cause abdominal pain, drowsiness, excessive thirst, headaches, vomiting, or hyperactivity. Tests have shown the lowest toxic dose in mice and rats is greater than 5000mg/kg. Montelukast should not be used during pregnancy or while breastfeeding, and elderly patients may have a longer half-life of the drug in their system.

Singulair Novel Uses: Which Conditions Have a Clinical Trial Featuring Singulair?

148 ongoing trials are investigating the potential of Singulair to provide an adequate response to conventional therapy, Asthma and Perennial Allergic Rhinitis (PAR) treatment.

Condition

Clinical Trials

Trial Phases

Asthma

97 Actively Recruiting

Phase 1, Phase 4, Not Applicable, Early Phase 1, Phase 2, Phase 3

Disease

0 Actively Recruiting

Asthma, Exercise-Induced

0 Actively Recruiting

Hay Fever

0 Actively Recruiting

Rhinitis, Allergic

0 Actively Recruiting

Singulair Reviews: What are patients saying about Singulair?

5

Patient Review

2/22/2020

Singulair for Allergic Asthma

I've tried everything on the market for my condition, and this is by far the best option. I don't have any issues with depression, but there has been some occasional dizziness.

5

Patient Review

6/1/2022

Singulair for Allergic Asthma

This pill has been a game-changer for me. I no longer have to rely on allergy medication, steroids, or shots.

4.7

Patient Review

5/29/2020

Singulair for Allergic Asthma

Zyrtec didn't do much for me in terms of my seasonal allergies, but Singulair really worked wonders. I noticed a difference within a few days of taking it, and now I don't need to use my rescue inhaler at all.

4

Patient Review

11/15/2020

Singulair for Exercise-Induced Bronchospasm Prevention

While it hasn't been perfect, this drug has helped me. I haven't experienced any of the negative side effects that I've read about in other reviews. (I actually wonder if they are using this drug as a scapegoat for their issues). After years of taking this, a mix up with the pharmacy and needing a call to Dr for refill, I ended up not taking it for a couple weeks. I had lousy allergy/sinus crud that makes people look weird at you during this Covid19 snafu.

4

Patient Review

6/22/2022

Singulair for Allergic Asthma

I began using Singulair yesterday and saw a significant difference in how clear my lungs felt. I was initially worried it was temporary, but after 24 hours I'm still feeling the same relief. This is really encouraging and has me excited for the future.

3.7

Patient Review

5/11/2022

Singulair for Controller Medication for Asthma

Singulair is effective for my allergies-induced asthma; however, it gives me terrible tooth pain. I've been to the dentist multiple times and they can't explain it. When I stopped taking Singulair, the pain went away after a few days; but as soon as I started again, the pain came back. So unfortunately, I have to say that I cannot take this medication.

3.3

Patient Review

4/27/2021

Singulair for Allergic Asthma

I had some serious mood swings while taking this, to the point where I had to stop and start a few times. If you're susceptible to that sort of thing, be warned.

3

Patient Review

11/26/2021

Singulair for Controller Medication for Asthma

I've been taking this medication for over a year now, and I honestly can't tell if it's doing anything.

2.7

Patient Review

2/7/2020

Singulair for Allergic Asthma

This provided excellent relief of my allergies and asthma, but the level of depression I experienced was really concerning. I felt like everything in my life was pointless, which is a shame because this otherwise would have been a great medication for me.

2.3

Patient Review

9/20/2022

Singulair for Controller Medication for Asthma

Singular worked for me while I was taking it, but I experienced some very intense and vivid nightmares. My physician just brushed it off when I told him, which wasn't particularly reassuring. Be warned that this medication can really mess with your head.

1

Patient Review

1/3/2020

Singulair for Inflammation of the Nose due to an Allergy

I had a really severe reaction to this drug in the form of hives. I even reported it to the FDA with pictures.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about singulair

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

What does Singulair do for you?

"This drug prevents leukotrienes, which are natural and can cause asthma and allergies, from making breathing difficult by reducing the inflammation in the airways."

Answered by AI

Is Singulair a steroid medication?

"Smith says

You can buy it under its brand name or as a generic. According to Dr. Smith, it blocks certainimmune pathways by preventing the body from making leukotrienes. These are chemicals that contribute to inflammation."

Answered by AI

Why was Singulair taken off the market?

"The U.S. Food and Drug Administration today announced that it is requiring a boxed warning – the agency's most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug. Montelukast is used to treat asthma and seasonal allergies.

The FDA is requiring a boxed warning – the agency's most prominent warning – for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug. Montelukast is used to treat asthma and seasonal allergies."

Answered by AI

Why do they recommend taking Singulair at night?

"Asthma symptoms are often worse at night, so Singulair is typically taken then. It usually starts working after the first dose, but some people don't notice a change for up to a week."

Answered by AI

Clinical Trials for Singulair

Image of University of California, Berkeley in Berkeley, United States.

Air Cleaners for Asthma and COPD

Any Age
All Sexes
Berkeley, CA

Fine particulate matter (PM2.5) is a type of air pollution made up of extremely tiny particles that can harm our health. Because PM2.5 particles are so small, they can travel deep into the lungs when inhaled. Exposure to PM2.5 can worsen asthma, cause breathing problems, increase the risk of heart attacks, and lead to early death, especially for people with existing heart or lung conditions. In California's Bayview Hunters Point (BVHP), a San Francisco community already facing high levels of air pollution and health impacts, sources of PM2.5 include industrial activity, commuter traffic, heavy-duty diesel trucks, freight trains, and port and maritime activities. The Reducing Exposure with Air Cleaners and Technology (REACT) Study is a partnership between University of California (UC) Berkeley, UC San Francisco, and Brightline Defense. The goal is to see if air cleaners (also called air purifiers) can help reduce indoor PM2.5 levels and improve respiratory health. For this study, the investigators will be recruiting 100 households in BVHP to participate. In each home, indoor PM2.5 levels and the health status of household members who are 13 years old or older and have asthma or chronic obstructive pulmonary disease (COPD) will be monitored. Each home will be part of the study for 90 to 120 days, depending on scheduling. Households must reside in BVHP for the duration of the study and not have used an air cleaner in their home within the last 6 months. On Day 1, each household will receive a PurpleAir indoor air quality monitor to measure PM2.5 levels in their home. * For the first 30 days, the investigators will measure the home's normal air quality (baseline). * After 30 days, each household will receive an air cleaner with information about how to best use it. * At that point, a PM2.5 indicator light will be turned on for half of the PurpleAir monitors. For the other half, indicator light will be kept turned off. This helps the investigators study whether seeing the air quality in real time changes how people use the air cleaner. * For the next 30 days, indoor PM2.5 levels will continue to be monitored. How often the air cleaner is used will also be tracked with smart plug data loggers. * After 60 days, more training and support will be offered to all participants and monitoring will continue over the final 30 days of the study.

Waitlist Available
Has No Placebo

University of California, Berkeley (+2 Sites)

Chelsea V Preble, PhD

Image of Allergy and Clinical Immunology Associates in Pittsburgh, United States.

Tilrekimig for Asthma

12 - 80
All Sexes
Pittsburgh, PA

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected. The study is seeking participants who: * Have a history of severe asthma for at least 12 months * Have had at least 2 asthma attacks (also known as exacerbations) within the last 12 months All participants will be given shots of study medicine or a placebo at the study clinic. Tilrekimig or the placebo will be given about every 4 weeks during the study. The study will compare the experiences of people receiving tilrekimig to those people who receive the placebo. This will help determine if tilrekimig is safe and effective.

Phase 3
Recruiting

Allergy and Clinical Immunology Associates (+10 Sites)

Pfizer CT.gov Call Center

Pfizer

Image of Ontario Tech University in Oshawa, Canada.

Temperature & Humidity Exposure for Asthma

11 - 18
All Sexes
Oshawa, Canada

The goal of this clinical study is to learn how different temperature and humidity conditions affect breathing, lung function, exercise capacity, symptoms, and other physical responses in children and youth aged 11 to 18 years with asthma, compared with age- and sex-matched children and youth without asthma. The main questions it aims to answer are: * How do different temperature and humidity conditions affect lung function, breathing symptoms, exercise capacity, and physiological responses in children and youth with asthma? * Do children and youth with asthma respond differently to these environmental conditions than children and youth without asthma? * Do sex and gender influence these responses? Researchers will compare children and youth with asthma to age- and sex-matched children and youth without asthma to see if temperature and humidity exposures have different effects on breathing, exercise performance, symptoms, and physiological responses. Participants will: * Attend two study visits in a climate-controlled chamber. * Be exposed to hot, cold, and varying humidity conditions for short periods of time. * Complete breathing tests and exercise testing before, during, and after each exposure. * Have symptoms, physical activity, and physiological responses monitored throughout the study.

Waitlist Available
Has No Placebo

Ontario Tech University

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Image of Children's Hospital Los Angeles in Los Angeles, United States.

Wearable Stethoscope for Childhood Asthma

4 - 17
All Sexes
Los Angeles, CA

The goal of this clinical trial is to evaluate a prototype wearable stethoscope designed to record lung sounds and assess asthma control in children and adolescents with asthma aged 4 to 17 years who are able to perform spirometry. The study aims to determine whether the prototype wearable stethoscope can accurately detect clinically meaningful changes in lung sounds associated with asthma control and response to bronchodilator treatment. The main questions it aims to answer are: * Does the prototype wearable stethoscope demonstrate agreement with recordings obtained from commercially available Thinklabs One Digital Stethoscopes in identifying normal and abnormal lung sounds? * Are lung sounds detected by the prototype wearable stethoscope associated with asthma symptom control as measured by the Childhood Asthma Control Test (cACT) or Asthma Control Test (ACT) Researchers will compare recordings obtained from the prototype wearable stethoscope with recordings obtained from FDA-cleared Thinklabs One Digital Stethoscopes to evaluate the prototype device's ability to detect abnormal lung sounds and changes in lung sounds following bronchodilator treatment.

Waitlist Available
Has No Placebo

Children's Hospital Los Angeles

Roberta Kato, MD

Image of SMS Clinical Research LLC in Garland, United States.

Tilrekimig for Severe Asthma

12 - 80
All Sexes
Garland, TX

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected. The study is seeking participants who: * Have a history of severe asthma for at least 12 months * Have had at least 2 asthma attacks (also known as exacerbations) within the last 12 months All participants will be given shots of study medicine or a placebo at the study clinic. The study will compare the experiences of people receiving tilrekimig to those people who receive the placebo. This will help determine if tilrekimig is safe and effective.

Phase 3
Recruiting

SMS Clinical Research LLC (+12 Sites)

Pfizer CT.gov Call Center

Pfizer

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We made a collection of clinical trials featuring Singulair, we think they might fit your search criteria.
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Image of University of Wisconsin in Madison, United States.

Mouthwash for Asthma

18+
All Sexes
Madison, WI

This study aims to determine whether an extra virgin olive oil-based water (EVOOW) mixture removes more fluticasone propionate (FP) from the mouth than water alone. More effective removal of residual FP deposits may help reduce the risk of complications associated with inhaled corticosteroid use, including obstructive sleep apnea (OSA), oral candidiasis (thrush), and speech and swallowing dysfunction. Participants will attend two separate testing visits, during which they will rinse and gargle with either EVOOW or water, after receiving 1 puff if fluticasone propionate. The visits will be scheduled 7-10 days apart. Total participation will last up to 3 weeks.

Phase 4
Waitlist Available

University of Wisconsin

Mihaela Teodorescu, MD, MS

Image of Pfizer Clinical Research Unit - New Haven in New Haven, United States.

PF-08103402 for Asthma

18 - 65
All Sexes
New Haven, CT

The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people. For Parts A, B, C, D and F, the study is seeking participants who: * Are healthy (do not have disease) males or females who can no longer have children, * Are 18 to 65 years old, * Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight For Part A (optional group or cohort 3: Japanese participants only): * A body weight of more than 45 kilograms (100 pounds). * Have 4 biological Japanese grandparents who were born in Japan. For Part E only: * Adults with a documented history of asthma (confirmed by a doctor) for at least 12 months before entering the study. * Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds). The study has six parts: Part A, Part B, Part C, Part D, Part E and Part F. The study medicine will be taken as a suspension or tablet by mouth 1 time a day (except in Parts B and E where it will be taken 1 time a day for 14 days) at the study clinic. The study will help understand: * how the body processes the study medicine in healthy participants (Parts A and B), * how much of the study medicine gets into the bloodstream and if food affects the amount of study medicine in the blood in healthy participants (Part C), * how the study medicine is broken down and leaves the body in healthy participants (Optional Part D), * how the study medicine is processed in adults with mild-to-moderate asthma (Optional Part E), * if taking the study medicine together with another medicine affects how each medicine is processed by the body in healthy participants (Optional Part F). Participants will take part in the study for about 10 weeks (Parts A and F), 12 weeks (Part B), 9 weeks (Parts C and D), and 16 weeks (Part E). During this time, they will have 2 study visits at the study clinic and up to 28 overnight stays (Part A), 18 overnight stays (Parts B and E), 10 overnight stays (Part C), 11 overnight stays (Part D), and 16 overnight stays (Part F). The study team will also call participants 1 time over the phone at the end of the study to assess how they are doing. Study measurements will be taken by body examination, monitoring side effects, blood and urine tests, heart tests (ECG), vital signs (blood pressure, pulse and respiratory rate), questionnaires (Parts C and E), stool samples (Part D only), and breathing tests (Part E only).

Phase 1
Recruiting

Pfizer Clinical Research Unit - New Haven

Pfizer CT.gov Call Center

Pfizer

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