Clinical trial NCT00395304
Conditions: Asthma
Sponsor: Milton S. Hershey Medical Center
Start date: 2007-03-01; Completion date: 2011-12-01
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Asthma is a common, serious illness among children in the United States. While a low dose of inhaled corticosteroids (ICS) may effectively control symptoms, some children may require additional medications to maintain adequate asthma control. This study compares the effectiveness of a higher dose of ICS, ICS combined with a long-acting beta-agonist (LABA) medication, and ICS combined with a leukotriene receptor antagonist (LTRA) medication at reducing the impact and severity of asthma exacerbations that occur in children with mild to moderate persistent asthma.

Detailed description:
Almost 9 million children in the United States have asthma, and it is a leading cause of hospitalizations and school absenteeism. Common asthma symptoms include wheezing, shortness of breath, chest tightness, and coughing. While there is no cure for asthma, most children who receive proper treatment are able to control symptoms and lead a normal life. Low doses of ICS are commonly prescribed to prevent symptoms and keep asthma under control. While this is usually sufficient to prevent asthma attacks, some children do not respond well to low dose ICS alone. For these children, their asthma symptoms may be more effectively controlled by either receiving a higher dose of ICS or receiving LABA or LTRA medications in combination with a low dose of ICS. Both LABA and LTRA medications are used to help control moderate to severe asthma. The purpose of this study is to compare the effectiveness of a high dose of ICS versus a low dose of ICS plus either LABA or LTRA medication at improving asthma control and reducing the severity of symptoms that occur in children with mild to moderate persistent asthma.

This study began with an 8-week screening period during which participants were monitored while they used an inhaler with a low dose of ICS medication. During this time, participants also attended one or two study visits. At each visit, participants underwent a physical examination, exhaled nitric oxide analysis, and lung function and airway pressure testing. After enrollment criteria were met, participants underwent these same evaluations again, and they completed questionnaires to assess asthma control, quality of life, and home environmental factors. Blood was collected and a methacholine challenge test was completed, which artificially triggers an asthma attack to determine the severity of an individual's asthma. Participants then were randomly assigned to one of six treatment sequences, each of which includes the following three regimens in a different order:

* Low dose of ICS and salmeterol, a LABA medication
* Low dose of ICS and montelukast, a LTRA medication
* Double dose of ICS

Each treatment period lasted 16 weeks, with study visits occurring weekly. A physical examination, blood collection, lung function and airway pressure testing, a methacholine challenge test, and questionnaires occurred at selected visits. Throughout the study, participants recorded asthma symptoms, peak expiratory flow rates, and rescue medication usage in a daily diary. The entire length of the study did not exceed 56 weeks.

Arms: arm 1: fluticasone propionate + montelukast, followed by fluticasone propionate, followed by fluticasone propionate + salmeterol arm 2: fluticasone propionate + montelukast, followed by fluticasone propionate + salmeterol, followed by followed by fluticasone propionate arm 3: fluticasone propionate + salmeterol, followed by fluticasone propionate, followed by fluticasone propionate + montelukast arm 4: fluticasone propionate + salmeterol, followed by fluticasone propionate + montelukast, followed by fluticasone propionate arm 5: fluticasone propionate, followed by fluticasone propionate + salmeterol, followed by fluticasone propionate + montelukast arm 6: fluticasone propionate, followed by fluticasone propionate + montelukast, followed by fluticasone propionate + salmeterol
Interventions: intervention 1: fluticasone propionate + montelukast intervention 2: fluticasone propionate intervention 3: fluticasone propionate + salmeterol
Intervention descriptions: intervention 1: Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck) intervention 2: Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline) intervention 3: Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)

Protocol documents: