Analysis of a phase III trial revealed that a combination of beta2-adrenergic agonist and an inhaled corticosteroid stopped the lung disfunction and lessened severe symptoms for mild-to-moderate asthma.
A combination of inhalers can help to slow the progression of asthma. The combination of albuterol and budesonide, an inhaled corticosteroid and a short-acting beta2-adrenergic agonist, slowed the deterioration of lung function. The patients in the Phase III study had mild-to-moderate asthma. Almost half of the 989 patients in the study had severe asthma exacerbations.
As per Bradley Chipps, MD, the albuterol-budesonide groups in the DENALI trial had mathematically less asthma damage. This waswhen compared to either the albuterol monotherapy or placebo groups after 12 weeks.
Furthermore, the percentage of patients who experienced at least one severe flare-up was lower in the groups that received high doses of albuterol and budesonide (2%). On the other hand, budesonide monotherapy had (2%), and medium doses of albuterol and budesonide (2.5%), respectively.
Research into combination of albuterol and budesonide to treat asthma:
At the American College of Allergy, Asthma, and Immunology (ACAAI) , Chipps stated that the combination of albuterol and budesonide is being developed as a needed treatment for asthma. Also, the clinical trial’s limitations required a four-times-a-day treatment protocol.
DENALI was developed to meet the FDA Combination Rule. It required confirmation that both components of the combination contributed to lung-function efficacy.
The goal of the current trial was to determine whether the combo product was effective in reducing deterioration and severe asthma exacerbations. Brian Kelly, MD, said that the results will make big a difference.
Patients may benefit from a combination of a short-acting beta agonist and an inhaled corticosteroid. More so than with albuterol, patients might be able to take this combination as needed. Although it is not yet accessible, the scientists are working for it.
The 989 patients had a mean age of 48 to 50 years old throughout the five trial arms. And around 60% of them were female. A little less than half had previously used inhaled corticosteroids. Between 2.5 and 2.9 inhalations of rescue medication were required on average each day across all research groups.
A combination inhaler does combat asthma well:
The high-dose (180/160) albuterol-budesonide combination was given to 197 asthmatics overall, four times each day. In contrast, 201 people were given a low-dose (180g/80g) albuterol-budesonide combination. 196 got albuterol (180), 199 got budesonide (160g), and 196 got placebo.
One or more episodes occurred in 34.5% of patients in the high-dose combination arm, 42.3% in the low-dose combination arm. Additionally, 58.7% on albuterol alone, 47.7% on budesonide alone, and 53.6% on placebo.
Asthma worsening was defined as one or more of the following conditions that persisted at least two consecutive days. The symptoms included:
- a 20% or greater decline in lung function tests,
- a need for four puffs of albuterol per day,
- with use at least two puffs higher than baseline,
- and increases in overnight and daytime symptom scores.
Severe asthma attack were defined as requiring a 2-3 day course of corticosteroids or steroids. An emergency room or urgent care visit for asthma that required systemic corticosteroids; or hospitalisation for asthma. Five patients experienced severe exacerbations with the high-dose combination compared to five individuals with the low-dose combination.
Severe symptoms occurred in 23 individuals on albuterol and five patients on budesonide in the monotherapy groups. On placebo, sixteen patients experienced serious exacerbations.
The albuterol-budesonide groups had numerically fewer asthma damage. This was over 12 weeks when compared to either the albuterol monotherapy or placebo groups. This was among the nearly 1,000 patients in the DENALI trial.
So, the mixture of inhalers did slowed the deterioration of lung function. Additionally, it reduced severe exacerbations in patients with mild-to-moderate asthma.