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Several clinical studies have confirmed the effectiveness of montelukast 10mg orally in adults with both asthma and allergic rhinitis. The objective of this phase IV study was to investigate the efficacy and safety of montelukast 10mg in adults with both asthma and allergic rhinitis in a real-life setting. Data from 5855 patients (mean age: 42.8±15.4 years) were collected and analyzed following treatment for 4−6 weeks. Efficacy was analyzed by comparing baseline values of: general, day- and night-time improvement in asthma symptoms, need for rescue medication or inhaled corticosteroids (ICSs), general and specific improvement in allergic rhinitis symptoms, reduction in rhinitis medication use, and general and specific quality of life (QoL) improvement with values collected at the end of the observation period of 4–6 weeks. Following treatment with 10mg montelukast 86.5% of patients reported a strong or marked improvement in day-time asthma symptoms and 88.5% reported improvement in night-time symptoms. A similarly high proportion of patients had a strong or marked improvement in all symptoms of allergic rhinitis (i.e. sneezing/itching (84%), rhinorrhea (81.7%), nasal congestion (79.3%), watery eyes (78.4%) and red or burning eyes (77.7%). The use of asthma and rhinitis medication was also reduced. 92.3% of all patients intended to continue montelukast therapy. Overall QoL was “very good” or “good” in 85.2% of patients and a “strong” or “marked” improvement in each of the four domains of sleep, work, everyday life and physical activity. Montelukast was well tolerated. Adverse drug reactions occurred in 14 out of 6158 patients. None of the adverse events was serious. Accordingly, montelukast 10mg is a safe and effective treatment for patients with both asthma and allergic rhinitis.
Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, atopic eczema: ISACC The international study of asthma and allergies in childhood (ISAAC) steering committee.
Asthma is estimated to affect ∼4–11% of the general population, while allergic rhinitis is estimated to affect between 10% and 30% of the general population.
Comorbidity of asthma and rhinitis has been well documented, suggesting a link between upper and lower airway disease and the hypothesis that asthma and rhinitis represent a systemic disease (i.e. one airway one disease).
The majority of patients with asthma also suffers from allergic rhinitis. It has been reported that up to 80% of patients with asthma also have rhinitis,
The Allergic Rhinitis and its Impact on Asthma (ARIA) Guidelines categorize patients’ allergic rhinitis as either “intermittent” or “persistent” with regards to duration.
These guidelines suggest to use combined strategies for the treatment of upper and lower airways. They propose a stepwise approach according to symptom severity and treatment response. Leukotriene antagonists, such as montelukast, were included in these guidelines as a treatment option for allergic rhinitis
The aim of the present article was to evaluate the efficacy and safety of add-on montelukast (10mg orally) to existing controller medication in the treatment of patients with asthma and allergic rhinitis.
Patients and methods
Study design
This multicentre, phase IV study with 3018 physicians was designed to investigate the efficacy of 10mg montelukast in adults with asthma and allergic rhinitis. Current therapy for each patient was recorded for ∼4–6 weeks of treatment between February 1st, 2004 and July 31st, 2004.
Patients
Patients were required to suffer from physician diagnosed asthma and allergic rhinitis. The minimum age of inclusion was 16 years. Montelukast was either used as a monotherapy or in addition to another anti-asthmatic therapy which was judged to be inadequate prior to the administration of the leukotriene receptor antagonist.
Baseline parameters
At visit 1 patients demographic data (gender and age), disease diagnosis and severity were recorded. Asthma severity was categorized according to recent guidelines as “intermittent”, “mild” or “moderate” and rhinitis was subdivided into “intermittent” or “persistent”. Asthma daytime symptoms (cough, wheezing, chest tightness and shortness of breath) and night-time symptoms (cough, shortness of breath and nocturnal awakenings), the need for rescue medication and inhaled corticosteroids (ICSs) were recorded together with symptoms of allergic rhinitis (sneezing/itching, runny nose, nasal congestion, watery eyes and red/burning eyes). Any recent medication and its perceived effectiveness to treat symptoms of rhinitis were also recorded. In addition, patients’ overall QoL was assessed as “good”, “satisfactory” or “reduced” and also more specifically according to the four domains of “difficulty sleeping”, “difficulty with work”, “difficulty with everyday life” and “limitation to daily activities”.
Efficacy parameters
At the end of the observation period (4–6 weeks) the following efficacy parameters were collected: general improvement in asthma symptoms, improvement of day- and night-time asthma symptoms, need for rescue medication, need for ICSs, general and specific improvement in allergic rhinitis symptoms, reduction in medication to treat the symptoms of allergic rhinitis, and general and specific QoL improvement. General improvements were categorized as “very good”, “good”, “satisfactory”, “sufficient” or “not sufficient”. Specific improvements in symptoms or QoL domains were categorized as “strong”, “marked”, “moderate” or “none”.
Safety parameters
Undesirable effects (UE) and adverse drug effects (ADE) were recorded during the treatment period with montelukast 10mg.
Statistical analysis
The methods of descriptive statistics were employed to analyze results from this post-marketing surveillance study and all analyses were performed using SAS (Statistical Analysis System version 8.2 for Windows). Case reports were considered evaluable for efficacy (efficacy group) if the following criteria were met: documented therapy with montelukast (case report form filled out); data recorded for visit 2; patient aged at least 16 years; beginning of monitored study medication not earlier than February 1st, 2004. Case reports were considered evaluable for drug safety (drug safety group) when the following criteria were met: documented therapy with montelukast 10mg. Undesirable effects were calculated on the “preferred term” level.
Results
Study population
In total, 6158 patients were identified by 3018 physicians. In all, 303 of these patients were not included into the study due to prior treatment with montelukast , age<16 years or missing data at visit 2 . Patients (5855) ( male; female) with a mean age of 42.8±15.4 years met all inclusion criteria and were included in this post-marketing surveillance study (Table 1). The average duration of observation was 5.5 weeks.
The majority of patients (40.5%) had moderate asthma with both day- and night-time symptoms in the last weeks prior to enrolment (Table 1). Cough was the most frequently reported day- and night-time symptom; more than half of the patients (58%) had nocturnal awakenings due to asthma (Table 2). There was a fairly even spread of patients with intermittent and persistent allergic rhinitis (51.8% and 47.0%, respectively); almost all patients reported symptoms of allergic rhinitis in the weeks prior to enrolment (Table 1), namely sneezing/itching, rhinorrhea, nasal congestion, watery eyes and/or red/burning eyes. In 70% of all patients overall QoL was reduced due to symptoms of asthma and rhinitis; most patients reported difficulty sleeping, work-related problems, impairments during everyday life and a limitation in daily activities due to asthma and/or rhinitis (Table 2 and Fig. 1). Well over half (58%) of the patients reported a moderate limitation in each of the four QoL domains while 16.8% of patients reported severe impairment in sleeping, 10.9% had severe work-related difficulties and 10.8% and 22.1% of patients reported severe limitations in their every day lives and physical activity, respectively (Fig. 1).
Table 2Pre-study symptoms and quality of life (QoL).
Following treatment with 10mg montelukast there was an overall improvement in asthma symptoms in the majority of patients, where 36.6% rated this improvement as “very good”, and 45.2% as “good” (Fig. 2). Day-time symptoms improved “strongly” or “markedly” in 86.5% of patients and 88.5% reported an improvement in night-time symptoms (Fig. 2). This was accompanied by a reduction in the requirement for other asthma medications such as ß2-agonists and ICSs. The number of patients who needed additional asthma medication decreased by 19.9% for ß2-agonist use and by 14.8% for ICS use; in addition, the mean number of puffs per day of ß2-agonists was reduced from 4.0 to 1.9 and from 2.5 to 1.6 for ICSs.
Figure 2Improvement in asthma. Sat: satisfactory; Suff: sufficient.
Adding montelukast 10mg to current asthma medication led to an overall improvement in allergic rhinitis symptoms in 86.5% of patients; 37.7% rated this improvement as “very good” and 45.8% as “good” (Fig. 3). Most patients reported a “strong” or “marked” improvement in all symptoms of allergic rhinitis; 77.7% reported a “strong” or “marked” improvement in red/burning eyes, 78.4% had a “strong” or “marked” improvement in watery eyes, and 79.3% reported similar improvement in nasal congestion, while 81.7% had a “strongly” or “markedly” improved rhinorrhea and 84% similarly improved sneezing/itching (Fig. 3). This was accompanied by a reduction in rhinitis medication in 88.1% of all patients . The strongest decrease was observed for nasal steroids with 77.1% ( of a total of 2031 patients). The use of α-sympaticomimetics was reduced in 75.9% of patients ( of a total of 759 patients), the use of eye drops in 69% of patients ( of a total of 2311 patients), anti-histamines in 69% of patients ( of a total of 3621 patients) and other rhinitis medications in 67.1% of patients ( of a total of 501 patients).
Figure 3Improvement in rhinitis. Sat: satisfactory; Suff: sufficient.
There was a “very good” or “good” improvement in 85.2% of patients in overall QoL and a “strong”/“marked” improvement in each of the four domains of sleep, work, everyday life and physical activity in 86.3% , 81.6% , 84.4% and 82.1% of patients, respectively (Fig. 4).
Figure 4Improvement in quality of life (QoL). Sat: satisfactory; Suff: sufficient.
Almost all patients (92.3%, ) planned to continue montelukast therapy after the end of the observation period, while only 7.2% of patients discontinued montelukast. In 2.6% further treatment was not required due to either almost completely resolved symptoms or due to the fact that the hay fever season had ended. A similarly large percentage (2.3%, ) discontinued therapy due to insufficient efficacy and 0.2% due to adverse events. 2.1% reported other or no reason for discontinuation.
Safety results
Montelukast was well tolerated in this large phase IV study. In 14 of 6158 patients (0.23%) 21 drug-related adverse events were reported. Most frequently headache, gastrointestinal infections and sleepiness were observed as single symptoms. None of the adverse events was serious.
Discussion
Asthma and allergic rhinitis have been linked clinically for many years. This has recently been acknowledged in the “one airway one disease” concept which underlines the hypothesis that both diseases share a common pathophysiology, characterized by inflammation of the respiratory mucosa by the same pro-inflammatory cells (e.g. eosinophils, Th2 lymphocytes and mast cells) and mediators (e.g. cytokines, histamine and leukotrienes).
Patients with asthma and rhinitis are twice as likely to require emergency care for asthma, and need more asthma-related hospitalizations and GP visits leading to higher asthma drug costs. In addition, patients with allergic asthma and rhinitis are significantly more likely to experience asthma attacks compared to patients with asthma alone.
Increased risk of asthma attacks and emergency visits among asthma patients with allergic rhinitis: a subgroup analysis of the improving asthma control trial.
In this phase IV study treatment with montelukast 10mg for 4–6 weeks (added to existing controller medication) was effective and well tolerated in patients with mild-to-moderate asthma and allergic rhinitis. There was a “strong” or “marked” improvement in both day- and night-time asthma symptoms as well as the symptoms of allergic rhinitis. These improvements were associated with a reduction in both asthma and rhinitis medication. Similar results have been previously reported from studies in which montelukast was added to existing therapies.
suggested that the mean increase in pulmonary function in patients with persistent asthma and a physician-based diagnosis of allergic rhinitis was greater when montelukast was added to a previous regimen of 800μg of budesonide/day versus doubling the dose of budesonide to 1600μg/day.
Adding montelukast to existing maintenance therapy also significantly improved the symptoms of seasonal allergic rhinitis in patients with concomitant active asthma.
Furthermore, the addition of montelukast significantly reduced daily rhinitis symptom scores, day-time nasal symptoms, nasal congestion, rhinorrhea and sneezing, night-time symptoms, especially nasal congesting upon awakening and day-time eye symptoms.
Both patients and physicians also reported significant improvements in the global evaluation of allergic rhinitis and asthma . Similar to our findings patients who took montelukast needed significantly less rescue medication which is likely to impact on healthcare resource use
as has been suggested by a study from Italy in children under 14 years of age where montelukast decreased the total use and costs of asthma rescues/acute and allergy medication over a 2-year period.
Sturkenboom MC, Picelli G, Scarmarcia B, et al. Change in use of asthma and allergy drugs after start of montelukast or other controllers in Italian children with asthma and allergic rhinitis. The World Allergy Congress, Munich, Germany 26 June–1 July, 2005.
The results of these studies which are now expanded with our post-marketing surveillance study, add further proof to the effectiveness of montelukast not only in a clinical setting, but also in a real-life setting.
Both asthma and allergic rhinitis can impair QoL which is further reduced in patients with both diseases.
Patients treated in an open label setting with montelukast 10mg orally reported a “strong”/“marked” improvement in their QoL most notably in the domains of sleep, work, everyday life and physical activity. Similar results have been obtained from controlled trials
which also showed that montelukast treatment improved rhinoconjunctivitis QoL overall score in patients with both asthma and allergic rhinitis. Significant ( each) improvements were noted in the QoL domains of nasal symptoms, eye symptoms, activity, sleep, emotions and practical problems.
In conclusion, based on previous findings asthma and allergic rhinitis often occur together and common treatment strategies have been recently suggested for both diseases. Our findings from a very large number of patients suggest that previous results from smaller, randomized controlled trials can be translated into a real-life setting, where montelukast is a safe and effective systemic treatment of both upper and lower airways in patients with both asthma and allergic rhinitis.
References
Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, atopic eczema: ISACC
The international study of asthma and allergies in childhood (ISAAC) steering committee.
Increased risk of asthma attacks and emergency visits among asthma patients with allergic rhinitis: a subgroup analysis of the improving asthma control trial.
Sturkenboom MC, Picelli G, Scarmarcia B, et al. Change in use of asthma and allergy drugs after start of montelukast or other controllers in Italian children with asthma and allergic rhinitis. The World Allergy Congress, Munich, Germany 26 June–1 July, 2005.
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