Comparison of oral montelukast and inhaled cromolyn with respect to preference, satisfaction, and adherence: a multicenter, randomized, open-label, crossover study in children with mild to moderate persistent asthma

Volovitz, Benjamin; Duenas-Meza, E.M.; Chmielewska-Szewczyk, D.; Kosa, Lajos; Astafieva, N.; Villarán, César; Pinacho-Daza, Carlos; Laurenzi, Martino; Jasan, Jay; Menten, Joris; Leff, Jonathan A.

doi:10.1016/s0011-393x(00)80032-6

Cited by 19 publications

(9 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Researcher observational analysis discovered that children under 2 years with neuroblastoma found it easier to chew tablets as they were unable to swallow the tablets whole . Chewable tablets of Montelukast were preferred to inhale cromolyn in a study of 266 children aged 6–11 years, although there were no details on the formulation to report whether this was just a preference for oral therapy compared to inhale or whether the chewable tablet was particularly preferred …”

Section: Discussionmentioning

confidence: 99%

“…[70] Chewable tablets of Montelukast were preferred to inhale cromolyn in a study of 266 children aged 6-11 years, although there were no details on the formulation to report whether this was just a preference for oral therapy compared to inhale or whether the chewable tablet was particularly preferred. [71] Solid dosage forms to be dispersed/ solubilised/eroded in the mouth (tablets, films, wafers, lozenges)…”

Section: Sizementioning

confidence: 99%

See 1 more Smart Citation

Evidence of acceptability of oral paediatric medicines: a review

Mistry

Batchelor

2017

Journal of Pharmacy and Pharmacology

125

109

View full text Add to dashboard Cite

Objectives The aim of this review was to map the currently available evidence on acceptability of oral paediatric medicines to aid in the selection of suitable platform formulations for the development of new acceptable paediatric products. Methods This process used a defined search strategy of indexed publications and included methods to assess the quality of the evidence retrieved. Key findings Taste/palatability was the most extensively studied area of paediatric medicine acceptability yet standard methods or criteria that define what is classed as acceptable to children is still to be defined. There have been many reports on the acceptability of medicines to paediatric populations yet major gaps in the acceptability knowledge base exist including the shape and dimensions of tablets, minitablets and capsules swallowed whole in infants and children; size and overall volume of multiparticulates; volume of liquids completely swallowed in infants and children; duration of retention within the oral cavity, size and taste of orodispersible tablets, lozenges and chewable tablets and the number of solid units dosed at each time point. Conclusions The review highlights where further information is required to support knowledge around acceptability of age-appropriate medicines. An algorithm to aid in selection of a formulation that is likely to be acceptable based on the age range to be treated by the medicine is presented as a result of this review. IntroductionThere is much evidence to support the need for age-appropriate medicines to treat paediatric patients. Pharmaceutical products for the paediatric population have a number of considerations that may not apply to adult products. In particular, the acceptability of a product needs to be clearly defined for paediatric populations and this is currently an area of great interest.The importance and incentive to study the acceptability, including palatability, of paediatric formulations was discussed in the reflection paper [1] and endorsed in the latest European Paediatric guideline on pharmaceutical development of formulations for paediatric use.[2] Before this regulatory change, there was no requirement for medicines to be demonstrated to be acceptable to children. Guidance issued by the European Medicines Agency (EMA) in 2013 states that patient acceptability must be an integral part of paediatric formulation development and described in the paediatric investigation plan (PIP).[3] Acceptability has previously been defined as 'an overall ability of the patient and caregiver (defined as "user") to use a medicinal product as intended (or authorised)'.[4] The palatability of paediatric medicines is one of the most important formulation factors in the acceptability of liquid medicines with potential to influence adherence to therapeutic regimens and outcomes.[5] Palatability has been defined as, 'the overall appreciation of a (often oral) medicine by organoleptic properties such as vision (appearance), smell, taste, aftertaste and mouth feel (e.g. texture, cooli...

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Sizementioning

confidence: 99%

Evidence of acceptability of oral paediatric medicines: a review

Mistry

Batchelor

2017

Journal of Pharmacy and Pharmacology

125

109

View full text Add to dashboard Cite

show abstract

“…[71] Moreover, satisfaction, as expressed by both children and parents, was significantly higher for montelukast than for sodium cromo-glycate (p < 0.001). After two 4-week treatment periods with a 2-week washout, 88% of parents preferred montelukast 5 mg/day compared with only 12% for sodium cromoglycate 2mg four times daily (p < 0.001) [primary endpoint, n = 249].…”

Section: Preference Satisfaction and Compliancementioning

confidence: 91%

Montelukast

Muijsers¹,

Noble²

2002

Pediatric Drugs

View full text Add to dashboard Cite

Oral montelukast has shown efficacy as a preventive treatment for asthma during clinical trials in children aged 2 to 14 years. The drug offers benefits over more standard therapies such as inhaled sodium cromoglycate and nedocromil in terms of compliance and convenience. In addition, the drug offers significant benefits when added to inhaled corticosteroids (according to secondary endpoints). Montelukast offers an effective, well tolerated and convenient treatment option for children with asthma.

show abstract

“…Although inhaled therapies have demonstrated acceptable efficacy and safety/tolerability in COPD, numerous studies have demonstrated improved patient satisfaction and compliance with oral versus inhaled medications [19]. Mechanism-based side-effects, such as dry mouth, tachycardia and visual disturbances, have limited the effectiveness of anticholinergic agents, and as a result, these drugs are currently delivered predominantly by the inhalational route to reduce systemic exposure.…”

Section: Discussionmentioning

confidence: 99%

An oral selective M3 cholinergic receptor antagonist in COPD

Lu¹

2006

Eur Respir J

View full text Add to dashboard Cite

Cholinergic antagonists have been used since the early 1900s as bronchodilators for chronic obstructive pulmonary disease (COPD). The present study investigated whether an oral muscarinic M3-selective anticholinergic agent (OrM3) would provide an improved therapeutic advantage compared with an inhaled anticholinergic agent in patients with COPD.A 6-week, multicentre, randomised, placebo-and active-controlled, parallel-group study was performed at 56 sites in the USA. In total, 412 male and female patients (aged 35-86 yrs) with a clinical history consistent with COPD were randomised to receive OrM3 0.5, 2, 3 or 4 mg orally once daily, ipratropium bromide 36 mg by inhalation four times daily or placebo.OrM3 demonstrated a significant dose-related improvement in serial forced expiratory volume in one second and a trend for dose-related improvement in patient-reported symptoms compared with placebo. However, at a dose that provided efficacy less than that of ipratropium, the incidence of dose-related, mechanism-based side-effects for OrM3 exceeded those observed for ipratropium.In patients with chronic obstructive pulmonary disease, the oral M3-selective agent did not offer a therapeutic advantage over inhaled ipratropium. These results do not support the hypothesis that high selectivity for muscarinic M3 receptors over airway neuronal M2 receptors will represent a more effective therapy than current inhaled anticholinergics in obstructive airway disease.

show abstract

Comparison of oral montelukast and inhaled cromolyn with respect to preference, satisfaction, and adherence: a multicenter, randomized, open-label, crossover study in children with mild to moderate persistent asthma

Cited by 19 publications

References 29 publications

Evidence of acceptability of oral paediatric medicines: a review

Evidence of acceptability of oral paediatric medicines: a review

Montelukast

An oral selective M3 cholinergic receptor antagonist in COPD

Contact Info

Product

Resources

About