Treatment outcomes with extra-fine beclomethasone-formoterol in patients with uncontrolled asthma

Study Synopsis

Title: Treatment outcomes of extra-fine beclomethasone-formoterol (Niveoli) in patients with asthma

A.Background: Very recently SAD (Small Airways Dysfunction) phenotype of Asthma has emerged, affecting 50-60% of asthmatics, which is characterized as difficult to treat asthma, more severe form of the disease, more uncontrolled asthma, night-time awakenings, obesity induced asthma, exercise induced asthma, seen in smokers and higher proportion in females as compared to males (2). Small airways contribute to approximately 10% of the total airways resistance and is known as the “silent zone”, i.e., until a significant portion of the airways are affected, there will be no clinical or spirometric manifestation of the disease. The medications that are currently available are of a diameter of 2-5m which do not easily reach upto the small airways. Therefore, there is a need for extra fine formulations for the treatment of SAD Asthma.

B.Research Question: What are the treatment outcomes with extra-fine beclomethasone-formoterol (Niveoli) in asthma patients who are uncontrolled on ICS/LABA combinations

C.Aim of the Study: To study the treatment outcomes with extra-fine beclomethasone-formoterol (Niveoli) in patients uncontrolled on existing ICS/LABA combination

D.Study Design: Real world, observational, follow-up study

E.Study Duration: 1 year (Complete study)

F.Sample Size: 150 Asthma patients

G.Study Population:

•Male and female patients ≥ 18 years uncontrolled on existing ICS/LABA combination

•Prescribed Niveoli for the very first time.

Inclusion Criteria

1.Male and female participants ≥18 years of age

2.Asthma patients uncontrolled on existing ICS/LABA combination

3.Have been prescribed Niveoli for the very first time

Exclusion criteria

1.Participants below the age of 18 years

2.Participants unable to perform spirometry or/and lung oscillometry.

3.Participants not willing to provide consent to participate.

H.Study location: Centres across the country who are part of the ARISE Network and who have consented to contribute to the study objectives and have access to the lung oscillometer and are prescribing Niveoli.

I.Data Collection variables/tools:

1.Lung Oscillometry (Antlia): Pre and Post (Preferable)

2.Spirometry (Pre and Post): Mandatory

3.Questionnairre – ACQ (Asthma Control Questionnairre) and AQOLQ (Asthma Quality of Life questionnairre)

4.PEFR – Peak Flow meter

5.Questions on exacerbations

6.Questions on medications

7.Questions on symptoms

8.SAD indicators

9.Adherence questionnairre

J.Study Outcomes

•Symptoms

•Quality of life

• Asthma control

•Lung function test (Spirometry/ PEFR/Lung Oscillometer)

•Exacerbations

K.Statistical Analysis Plan:

The primary objective of this study is to report the efficacy and safety of extra-fine beclomethasone-formoterol (Niveoli) in asthma patients uncontrolled on ICS/LABA combination. Analysis will be performed using simple descriptive statistics which mainly includes frequency and percentages for all categorical variables, and mean and standard deviation for continuous variables. Correlation analysis will be used to explore associations between lung oscillometry and spirometric parameters. Repeated measured of ANOVA will be used to analyse change in lung function parameters from baseline to 3 months and 6 months. All statistical analysis will be performed using SPSS V247.0 and p-value of 0.05 will be considered as statistically significant for all comparative analysis.