A descriptive study on usage of inhaled steroids in children

Objective To determine the use of inhaled corticosteroids in a cohort of children at Lady Ridgeway Hospital (LRH), Colombo. Method A cross-sectional descriptive study was carried out on all clinic and in-ward patients of ward 4 LRH receiving inhaled corticosteroids for more than 6 months. A pre-tested, structured interviewer administered questionnaire was used to collect data on the demography, type of drug and device, adherence and response to therapy. Results The study population comprised 185 children, 55% of whom were males and 35% in the 25 year age group. In 90% the inhaled steroid was beclomethasone. Metered dose inhaler was used by 64% and dry powder inhaler by 36% for steroid delivery. Ninety six percent of the study population used the correct inhaler device for their age group. The commonest indication for inhaled steroid was moderate persistent bronchial asthma. The technique was demonstrated at initiation to 99.5% of the users by the prescriber. Eighty four percent of the study population practised a ‘good’ technique. Nearly 80% of the patients adhered to the therapy daily and attended the clinic regularly. Around 15% needed hospitalisation. About 96% showed restricted lifestyles, mainly consumption of iced food. Inhaler technique of the patient had a significant effect on the clinical response to therapy (p<0.05). Conclusions Beclomethasone was the most commonly used inhaled corticosteroid in the study. Ninety six percent used the correct inhaler device for their age group. Inhaler technique had a significant effect on the clinical response. About 96% had restricted lifestyle despite optimal control. ___________________________________________ 1 Senior Registrar in Paediatrics, 2 Consultant Paediatrician, Lady Ridgeway Hospital, Colombo (Received on 10 September 2009. Accepted on 19 December 2009) Introduction Bronchial asthma is a common respiratory illness with long term morbidity among children. According to the International Study of Asthma and Allergies in Childhood (ISAAC), prevalence rates of childhood asthma in Sri Lanka can be as high as 30-40% 1 . It is also a common cause of school absenteeism 1,2,3 . Denial of the disease, reluctance to use inhalers, myths regarding inhalers and poor compliance 1,3,4,5 further aggravate the issue. Despite many clinical trials, introduction of newer potent treatment modalities and management guidelines 1,6,7 , doctors and parents encounter many practical difficulties and asthma retains a considerable respiratory morbidity among children. It is accepted worldwide that inhaled steroids have become the cornerstone of long-term prophylaxis imparting better control of the disease 3,8 . It is evident that in recommended dosages steroids are safe and effective in infants and younger children with asthma 3,8,9,10 . Childhood asthma directly and indirectly leads to many complications including growth failure, chest deformities, restricted physical activity, recurrent hospitalizations and school absenteeism. Prophylactic inhaled corticosteroids have been shown to reduce mortality 8 , morbidity, improve lung function, reduce acute exacerbations and ensure near normal life in children 6,8 . However, availability, accessibility and affordability have become limitations in gaining maximum benefit. Inhaled corticosteroids are currently available in some Sri Lankan Public Health Sector hospitals free of charge. It is widely accepted and proven that proper technique and good adherence are essential for it to be most cost effective 9,10 .


Introduction
Bronchial asthma is a common respiratory illness with long term morbidity among children. According to the International Study of Asthma and Allergies in Childhood (ISAAC), prevalence rates of childhood asthma in Sri Lanka can be as high as 30-40% 1 . It is also a common cause of school absenteeism 1,2,3 . Denial of the disease, reluctance to use inhalers, myths regarding inhalers and poor compliance 1,3,4,5 further aggravate the issue. Despite many clinical trials, introduction of newer potent treatment modalities and management guidelines 1,6,7 , doctors and parents encounter many practical difficulties and asthma retains a considerable respiratory morbidity among children. It is accepted worldwide that inhaled steroids have become the cornerstone of long-term prophylaxis imparting better control of the disease 3,8 . It is evident that in recommended dosages steroids are safe and effective in infants and younger children with asthma 3,8,9,10 .
Childhood asthma directly and indirectly leads to many complications including growth failure, chest deformities, restricted physical activity, recurrent hospitalizations and school absenteeism. Prophylactic inhaled corticosteroids have been shown to reduce mortality 8 , morbidity, improve lung function, reduce acute exacerbations and ensure near normal life in children 6,8 . However, availability, accessibility and affordability have become limitations in gaining maximum benefit. Inhaled corticosteroids are currently available in some Sri Lankan Public Health Sector hospitals free of charge. It is widely accepted and proven that proper technique and good adherence are essential for it to be most cost effective 9,10 .

Objective
To determine the usage of inhaled corticosteroids in a cohort of children managed at Lady Ridgeway Hospital for Children, Colombo. During the study period the principal investigator personally reviewed the patients. Child and parents / caregivers were given explanations about the study, informed consent was obtained and patients were serially enrolled. At the end of interview, child and parent were requested to demonstrate the inhaler technique, and any wrong technique was rectified by demonstrating the correct method.
Beclomethasone was the inhaled corticosteroid used in 167 (90%) children and 18 (10%) children were on combined preparations.
Corticosteroids were delivered via a dry powder inhaler (DPI) in 36% of cases (DP haler 35%, Cyclohaler 1%). The metered dose inhaler (MDI) was used for steroid delivery in 64% cases, 25% using the volumatic spacer without a mask, 23% the babyhaler spacer device and 16% the volumatic spacer with a mask. Ninety six percent of the study population used the appropriate device for their age group (Table 2). The most overlooked steps in MDI use were holding the breath after inhaling the drug (48%) and slowly releasing the breath after the inhalation of the drug (47%). DPI users overlooked tilting the head slightly while inhaling the drug (42%) and holding the breath after inhaling the drug (25%).
Compliance of patients towards inhaled steroids was assessed by noting the adherence to therapy and clinic attendance. This is shown in Table 3.

Changing of therapy
Of the study population 19 (10%) changed therapy at least once for the past 6 months. Among them, 11 (58%) changed during past 3 months, 05 (26%) changed during past 1 month and 03 (16%) during past 6 months. Among those who needed to change therapy 09 (47%) changed their drugs, 07 (37%) changed the dosage, 02 (10.5%) had the device changed and 02 (10.5%) had the frequency adjusted. Most common (97%) reason to change the therapy was poor response while 02 (10.5%) changed therapy due to improvement of the condition.

Response to therapy
Response to the therapy was measured using multiple parameters such as school absence, use of rescue medication, duration and treatment received during hospital stay and life style restriction.
Overall control of the disease without considering hospitalization was very good in 101 (55%), good in 23 (12%), moderate in 03 (2%) and poor in 58 (31%) among the population. Here the school absenteeism and the need for rescue medication were considered.
• Very good: No school absenteeism and no rescue medication used.
• Good: <5 days of school absence during last 3 months or needed bronchodilator inhaler therapy.
• Moderate: 5 -10 days of school absence for the last 3 months or needed home nebulisation.
• Poor: >10 days of school absence during last 3 months or nebulisation at OPD/ private sector.
Of the study population 30 (16%) needed hospitalization during the past 6 months. Of those admitted to hospital 14 (45%) stayed for 3-4 days, 12 (43%) stayed less than 3 days, 02 (6%) stayed 5-6 days and another 02 (6%) stayed for more than 1 week in the hospital. All patients needed nebulisation during their hospital stay, while 27 (91%) received oral steroids. Only 03 (11%) needed IV steroids and none needed IV aminophylline, IV magnesium sulphate or ICU care during the study period.
Response to therapy in patients who needed hospitalization was very good in 25 (83%), good in 04 (14%), and moderate in 01 (3%). This was assessed by the following criteria: • Very good: No hospitalizations.
• Good: 1-2 hospitalizations for the last 6 months and duration of hospital stay <4 days and needed only nebulisation and oral steroids as treatment.
• Moderate: 3-5 hospitalisations for the last 6 months or duration of stay 5-7 days or needed IV Steroids as treatment.
• Poor: >5 hospitalisations for the past 6 months or duration of stay >7 days or needed IV aminophylline or IV magnesium sulphate as treatment.
• Very poor: >5 hospitalisations for the past 6 months duration of stay >7 days and needed ICU care.
Of the study population 178 (96%) had lifestyle restrictions where 74 of 97 (76%) had restricted participation of sports at school, 78 of 97 (80%) had restriction of sports outside the school, 147 (80%) were deprived of iced food and 44 (24%) had sleep disturbances.

Discussion
In this study moderately persistent asthma was the commonest indication for prophylaxis and a significant proportion only had nocturnal cough as their presentation prior to starting prophylaxis. Majority of patients were on an appropriate device for their respective age groups. Both these fall in line with the Sri Lanka Medical Association guidelines 1 . Although change of therapy was observed in a minority, it was predominantly due to unsatisfactory response. The inhaled steroid therapy was prescribed mainly by the paediatricians attached to the government sector. Almost all recipients (99.5%) were demonstrated the correct technique by the prescriber and in the majority it was reinforced in between the follow up care and our results showed better values than other studies 4 . Most of the users' compliance and clinic attendance were satisfactory.
In contrast to the common belief of near normal activity following inhaled steroids, in our study it was revealed that the majority of parents denied their children iced food (in spite of optimal asthma control) and restricted physical activities. Although acute severe asthma management may require intravenous (IV) aminophylline, IV magnesium sulphate or even intensive care unit admission, none of our patients needed them probably due to better long-term control achieved by inhaled steroids. This fact was proven by many studies 3,6 . All admitted patients required nebulisation and most of them also required oral steroids. It was clearly observed that the clinical response and reduction of hospitalization directly depended upon the proper technique.

Conclusions
• Beclomethasone was the most commonly used inhaled corticosteroid in the study.
• Ninety six percent used the correct inhaler device for their age group.
• Inhaler technique had a significant effect on the clinical response.
• About 96% had restricted lifestyle despite optimal control.

Recommendations
It is vital to educate the parents and children that asthmatic children can lead a normal life by adhering to optimal asthma therapy. Restriction of food especially iced products is not necessary in most patients. We should not ignore the fact that repeat reenforcement of inhaler technique during clinic visits is of immense benefit to the patient for a better life style and long-term outcome.