Effects of levodopa oral inhalation: A Synthesis of Findings from 22 Studies

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Original Abstract of the Article

Key Findings

Several studies have investigated the efficacy and safety of inhaled levodopa (CVT-301) for treating Parkinson's disease (PD), particularly for managing "OFF" periods, which occur when the effects of oral levodopa wear off. 11 3 8 10 15 12 9 13 16 18 14 CVT-301 has demonstrated a faster onset of action and more sustained effects compared to oral levodopa. 10 6 Furthermore, long-term use of CVT-301 for up to 12 months has not shown significant adverse effects on pulmonary function. 16 5

Benefits and Risks

Benefits Summary

Inhaled levodopa (CVT-301) may help improve "OFF" periods in Parkinson's disease, leading to better symptom control and improved quality of life. 11 15 12 Compared to oral levodopa, it may provide faster symptom relief and longer-lasting effects. 10 6 Additionally, long-term use has not shown significant adverse effects on lung function. 16 5

Risks Summary

The most common side effect associated with inhaled levodopa (CVT-301) is cough. 10 9 Other reported side effects include upper respiratory tract infections, nausea, sputum discoloration, and dyskinesia. 7

Comparison Across Studies

Commonalities

Many studies have consistently found that inhaled levodopa (CVT-301) shows potential for improving "OFF" periods in Parkinson's disease, leading to better symptom control and improved quality of life. 11 3 8 10 15 12 9 13 16 18 14 Moreover, studies consistently indicate that CVT-301 exhibits a faster onset of action compared to oral levodopa. 10 6

Differences

Studies may differ in their specific findings regarding the details of CVT-301's effectiveness and safety. For instance, some studies report cough as a side effect, while others describe it as mild, occurring only during inhalation, and resolving quickly. 10 7 9 Similarly, variations may exist in the methods and dosages of CVT-301 administration across studies. 11 15 12

Consistency and Contradictions in Results

While several studies support the potential benefits of inhaled levodopa (CVT-301) for managing "OFF" periods in Parkinson's disease, some studies also report side effects such as cough. 11 3 8 10 15 12 9 13 16 18 14 10 7 9

Real-World Application Considerations

While inhaled levodopa (CVT-301) shows promise in treating "OFF" periods in Parkinson's disease, individual responses to the medication may vary. 11 3 8 10 15 12 9 13 16 18 14 Therefore, it's crucial to work closely with your doctor to determine the appropriate dosage and administration method. 10 7 9

Limitations of Current Research

The number of studies on inhaled levodopa (CVT-301) is relatively limited. 11 3 8 10 15 12 9 13 16 18 14 Further research is needed to better understand CVT-301's long-term effects and safety profile. 10 7 9

Future Research Directions

Future research should focus on long-term efficacy and safety studies of inhaled levodopa (CVT-301), comparative studies with other treatment options, and investigations into its effectiveness across different patient populations with Parkinson's disease. 11 3 8 10 15 12 9 13 16 18 14

Conclusion

Inhaled levodopa (CVT-301) holds promise as a new treatment option for managing "OFF" periods in Parkinson's disease. 11 3 8 10 15 12 9 13 16 18 14 However, further research is crucial to establish its long-term effectiveness and safety profile. 10 7 9 It is important to stay informed about ongoing research and discuss treatment options with your healthcare provider to determine the most suitable approach for managing Parkinson's disease. 11 3 8 10 15 12 9 13 16 18 14

Literature analysis of 22 papers
Positive Content
22
Neutral Content
0
Negative Content
0
Article Type
7
1
1
11
22
1.

Comparison of the sedating effects of levocetirizine and cetirizine: a randomized, double-blind, placebo-controlled trial.

Author: TzanetosDouglas B, FahrenholzJohn M, ScottTheresa, BuchholzKristina

Tolerable for patients with sedation history
No significant difference in sedation compared to cetirizine

Levocetirizine was not found to be significantly less sedating than its parent drug cetirizine in patients who had previously reported sedation with cetirizine. The study suggests that many patients who perceive sedation with cetirizine might tolerate it if given in a masked manner.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

2.

Sedative Effects of Levocetirizine: A Systematic Review and Meta-Analysis of Randomized Controlled Studies.

Author: SnidvongsKornkiat, SeresirikachornKachorn, KhattiyawittayakunLikhit, ChitsuthipakornWirach

Allergy treatment
Sedative effects

This study investigated the sedative effects of levocetirizine. The study found that levocetirizine has modest sedative effects with a risk ratio of 1.67 when compared with placebo. The sedative effects observed for levocetirizine are not different from other second-generation antihistamines.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

3.

Levodopa: A new look at an old friend.

Author: OlanowC Warren, StocchiFabrizio

Continuous l-dopa levels
Reduced motor complications
Dyskinesia
Motor fluctuations

Levodopa is the most effective antiparkinsonian agent, but chronic treatment can lead to motor complications in Parkinson's disease (PD) patients. This article discusses recent advances in managing these complications, including dose optimization, rescue therapies, and continuous l-dopa delivery approaches.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

Pulmonary Safety and Tolerability of Inhaled Levodopa (CVT-301) Administered to Patients with Parkinson's Disease.

Author: LeWittPeter A, PahwaRajesh, SedkovAlexander, CorbinAnn, BatyckyRichard, MurckHarald

Improved OFF symptoms

CVT-301, an inhaled levodopa (LD) formulation, is under development for relief of OFF periods in Parkinson's disease (PD). This study evaluated pulmonary function in patients treated with a single dose of CVT-301 or placebo for 3 hours, or received multiple doses/day for 4 weeks.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

A 12-month, dose-level blinded safety and efficacy study of levodopa inhalation powder (CVT-301, Inbrija) in patients with Parkinson's disease.

Author: FarbmanEric S, WatersCheryl H, LeWittPeter A, RudzińskaMonika, KlinglerMichael, LeeAngela, QianJenny, OhCharles, HauserRobert A

Improved ON states
Reduced OFF time
Pulmonary function decline

CVT-301 (Inbrija®), a levodopa inhalation powder, was well-tolerated for 12 months in patients with Parkinson's disease. The drug maintained improvement in achieving ON states and reducing daily OFF time.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

Pharmacokinetics of Inhaled Levodopa Administered With Oral Carbidopa in the Fed State in Patients With Parkinson's Disease.

Author: SafirsteinBeth E, EllenbogenAaron, ZhaoPing, HenneyHerbert R, Kegler-EboDeena M, OhCharles

Parkinson's disease treatment
OFF periods

CVT-301, a levodopa inhalation powder, is safe and effective for treating OFF period symptoms in patients with Parkinson’s disease.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Profile of inhaled levodopa and its potential in the treatment of Parkinson's disease: evidence to date.

Author: PatelAmi B, Jimenez-ShahedJoohi

PD treatment
Cough
Dyskinesia
Nausea
Upper respiratory infection

This article reviews the clinical development of inhaled levodopa, a newly emerging therapeutic option for the treatment of "off" symptoms associated with Parkinson's disease (PD).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

A pulmonary formulation of L-dopa enhances its effectiveness in a rat model of Parkinson's disease.

Author: BartusRaymond T, EmerichDwaine, Snodgrass-BeltPam, FuKaren, Salzberg-BrenhouseHeather, LafreniereDenise, NovakLeah, LoEe-Sing, CooperThomas, BasileAnthony S

Faster L-dopa delivery
Improved motor function

This study compared the pharmacokinetics and pharmacodynamics of pulmonary and oral L-dopa administration in rats with Parkinson's disease. The study found that pulmonary administration of L-dopa produced more rapid and robust effects on striatal dopamine levels and motor function compared to oral administration, suggesting potential advantages for pulmonary delivery in Parkinson's disease.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

The Clinical Development of Levodopa Inhalation Powder.

Author: HauserRobert A, LeWittPeter A, WatersCheryl H, GrossetDonald G, BlankBurkhard

Parkinson's disease treatment
Cough

Inhaled levodopa powder (Inbrija) is approved for on-demand treatment of OFF periods in patients with Parkinson's disease. The 84-mg dose is administered via a breath-actuated inhaler and provides pulmonary delivery of levodopa to the systemic circulation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

10.

Preclinical and clinical assessment of inhaled levodopa for OFF episodes in Parkinson's disease.

Author: LippMichael M, BatyckyRichard, MooreJerome, LeinonenMika, FreedMartin I

Improved motor function
Rapid onset of action
Cough

CVT-301, an inhaled levodopa powder formulation, shows promise for treating OFF episodes in Parkinson's disease. It delivers levodopa rapidly, improving motor function compared to oral levodopa, with cough being the most common adverse event.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

11.

A randomized trial of inhaled levodopa (CVT-301) for motor fluctuations in Parkinson's disease.

Author: LeWittPeter A, HauserRobert A, GrossetDonald G, StocchiFabrizio, Saint-HilaireMarie-Helene, EllenbogenAaron, LeinonenMika, HampsonNeil B, DeFeo-FrauliniTia, FreedMartin I, KieburtzKarl D

Rapid onset of action
Relieve OFF episodes

CVT-301, a levodopa inhalation powder, is being studied as a potential treatment for Parkinson's disease (PD) patients experiencing motor fluctuations.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

12.

Old Drugs, New Delivery Systems in Parkinson's Disease.

Author: GuptaHarsh V, LyonsKelly E, PahwaRajesh

Improved Delivery
Parkinson's Treatment

This review explores newer delivery options for drugs used in Parkinson's disease (PD) to address motor fluctuations caused by variations in plasma levodopa levels. It covers infusion therapy with apomorphine, modified dopamine agonists, various oral carbidopa/levodopa formulations, inhaled levodopa, intrajejunal levodopa infusion, and sublingual apomorphine, highlighting their advantages, doses, and adverse effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

Safety and efficacy of CVT-301 (levodopa inhalation powder) on motor function during off periods in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 trial.

Author: LeWittPeter A, HauserRobert A, PahwaRajesh, IsaacsonStuart H, FernandezHubert H, LewMark, Saint-HilaireMarie, PourcherEmmanuelle, Lopez-ManzanaresLydia, WatersCheryl, RudzínskaMonika, SedkovAlexander, BatyckyRichard, OhCharles,

Treats Parkinson's disease

This study evaluated the safety and efficacy of CVT-301, an inhaled levodopa powder, for treating Parkinson's disease during "off periods" when oral levodopa is less effective.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Inhaled levodopa in Parkinson's disease patients with OFF periods: A randomized 12-month pulmonary safety study.

Author: GrossetDonald G, DhallRohit, GurevichTanya, KassubekJan, PoeweWerner H, RascolOlivier, RudzinskaMonika, CormierJennifer, SedkovAlexander, OhCharles

Pulmonary Safety

This study evaluated the safety, including pulmonary safety, of CVT-301, an inhaled levodopa therapy for Parkinson's disease, over 12 months. The study found that CVT-301 was generally safe and well-tolerated, with no significant adverse events related to pulmonary function.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

CVT-301 for the treatment of Parkinson's disease.

Author: ShpinerDanielle S, BetteSagari, Di LucaDaniel G, MargoleskyJason

Parkinson's treatment

This study reviews the available treatments for motor and nonmotor fluctuations in Parkinson's disease (PD), including medications and surgical procedures. The review focuses on CVT-301 (Inbrija), an inhaled formulation of levodopa (LD), which provides a safe and effective delivery mechanism for rescue therapy in PD patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

18.

Inhaled levodopa for intermittent treatment of OFF episodes in patients with Parkinson's disease.

Author: SimõesRita Moiron, Castro CaldasAna, FerreiraJoaquim J

Parkinson's disease treatment
Rapid symptom reversal
Pulmonary adverse events

Inhaled levodopa is a promising treatment for Parkinson's disease OFF periods, offering rapid symptom relief and potentially overcoming the limitations of oral administration.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

19.

Novel Levodopa Formulations for Parkinson's Disease.

Author: FreitasMaria Eliza, Ruiz-LopezMarta, FoxSusan H

Improved levodopa bioavailability
Improved motor function
Reduced motor fluctuations
Cough
Gastrointestinal side effects

This review summarizes the pharmacokinetic aspects, clinical efficacy, and potential adverse events of novel levodopa formulations currently available or under development for Parkinson's disease.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

21.

Pharmacological Treatment of Tremor in Parkinson's Disease Revisited.

Author: PirkerWalter, KatzenschlagerRegina, HallettMark, PoeweWerner

Tremor control
Adverse effects

Levodopa is the most effective drug for Parkinson's disease tremor, but other medications, such as dopamine agonists and anticholinergics, can be used as well. However, anticholinergics have limited benefits due to their side effects. For patients with drug-refractory tremor, deep brain stimulation and focused ultrasound are potential treatments. Surgery can also be highly effective in selected patients without motor fluctuations.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

22.

Regional cerebral blood flow in parkinsonism. Measurement before and after levodopa.

Author: MelamedE, LavyS, CooperG, BentinS

Levodopa treatment in Parkinson’s disease patients did not induce significant alterations in cerebral blood flow.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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