CTRI/2024/02/062844 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On:
16/02/2024
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Follow Up Study
Study Design
Other
Public Title of Study
To study the improvement in symptoms and quality of life in patients with severe form of asthma after prescribing them a medication called extra-fine beclomethasone which reached right to the small airways
Scientific Title of Study
Treatment outcomes with extra-fine beclomethasone-formoterol in patients with uncontrolled asthma
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sundeep Salvi
Designation
Director
Affiliation
Chest Research and Training Pvt Ltd
Address
Sakore Nagar, Faith Centre. Viman nagar. Pune Sakore Nagar, Faith Centre. Viman nagar. Pune Pune MAHARASHTRA 411060 India
Phone
09604643295
Fax
Email
deesha.ghorpade@yahoo.in
Details of Contact Person Scientific Query
Name
Dr Sundeep Salvi
Designation
Director
Affiliation
Chest Research and Training Pvt Ltd
Address
Sakore Nagar, Faith Centre. Viman nagar. Pune Sakore Nagar, Faith Centre. Viman nagar. Pune Pune MAHARASHTRA 411060 India
Phone
09604643295
Fax
Email
deesha.ghorpade@yahoo.in
Details of Contact Person Public Query
Name
Deesha Ghorpade
Designation
Head, Academic Research
Affiliation
Pulmocare Research and Education Foundation
Address
Sakore Nagar, Faith Centre. Viman nagar. Pune Sakore Nagar, Faith Centre. Viman nagar. Pune Pune MAHARASHTRA 411060 India
Phone
09604643295
Fax
Email
deesha.ghorpade@yahoo.in
Source of Monetary or Material Support
Cipla Pvt Ltd. Peninsula Business Park, Ganapatrao Kadam Marg, Lower Parel West, Mumbai, Maharashtra 400013
Primary Sponsor
Name
Cipla Pvt Ltd
Address
Peninsula Business Park, Ganapatrao Kadam Marg, Lower Parel West, Mumbai, Maharashtra 400013
Inclusion Criteria
1.Male and female participants more than equal to 18 years of age
2.Asthma patients uncontrolled on ICS LABA combination
3.Have been prescribed Niveoli for the very first time.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
•Symptoms
•Quality of life
•Asthma control
•Lung function test (Spirometry,Lung Oscillometer and PEFR if available)
•Exacerbations and current medications
Baseline, 3month, 6month
Secondary Outcome
Outcome
TimePoints
•Symptoms
•Quality of life
•Asthma control
•Lung function test (Spirometry,Lung Oscillometer and PEFR if available)
•Exacerbations and current medications
Baseline, 3month, 6month
Target Sample Size
Total Sample Size="150" Sample Size from India="150" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
29/02/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
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 zoneâ€, 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 2-5ïm 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.