| CTRI Number |
CTRI/2025/08/092454 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An open label, parallel group Trial to compare effectiveness of Pressurized Metered-Dose Inhaler vs Dry Powder Inhaler for Budesonide/Formoterol Combination Delivery in Asthma Control. |
|
Scientific Title of Study
|
Pressurized Metered-Dose Inhaler vs Dry Powder Inhaler for Budesonide/Formoterol Combination Delivery in Asthma Control: A Randomized Parallel Group Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Diksha Attri |
| Designation |
MBBS, MD (Pulmonology) |
| Affiliation |
Indus International Hospital |
| Address |
Department of Pulmonology
Indus International Hospital, Chandigarh Ambala Highway, Derabassi, Punjab, India 140507
Rupnagar
PUNJAB
140507
India |
| Phone |
9814053459 |
| Fax |
|
| Email |
attridiksha29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diksha Attri |
| Designation |
MBBS, MD (Pulmonology) |
| Affiliation |
Indus International Hospital |
| Address |
Department of Pulmonology
Indus International Hospital, Chandigarh Ambala Highway, Derabassi, Punjab, India 140507
Rupnagar
PUNJAB
140507
India |
| Phone |
9814053459 |
| Fax |
|
| Email |
attridiksha29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Dharmender Singh Lather |
| Designation |
Sr. Manager Clinical Trial |
| Affiliation |
Indus International Hospital |
| Address |
Indus International Hospital, Chandigarh Ambala Highway, Derabassi, Punjab, India 140507
Rupnagar
PUNJAB
140507
India |
| Phone |
9215810327 |
| Fax |
|
| Email |
Clinicalmanager@indushospitals.com |
|
|
Source of Monetary or Material Support
|
| Indus International Hospital, Chandigarh Ambala Highway, Derabassi, Punjab 140507 |
|
|
Primary Sponsor
|
| Name |
Indus International Hospital |
| Address |
Department of Pulmonology
Chandigarh-Ambala Highway,
Derabassi, Mohali, Punjab 140507 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Diksha Attri |
Indus International Hospital |
Lower Ground floor
Department Of Pulmonology, Chandigarh Ambala Highway, Derabassi, Punjab 140507
Rupnagar
PUNJAB |
9814053459
attridiksha29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indus International Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Budesonide/Formoterol DPI |
Medication: Budesonide 200 microgm + Formoterol 6 microgm per inhalation
Device: Dry powder inhaler (Turbuhaler or equivalent)
Dosage: 1 inhalation twice daily
Total Daily Dose: Budesonide 400 microgm + Formoterol 12 microgm
Administration: Morning and evening with 12-hour interval |
| Intervention |
Budesonide/Formoterol pMDI |
Medication: Budesonide 200 microgm + Formoterol 6 microgm per inhalation
Device: Pressurized metered-dose inhaler (pMDI)
Total Daily Dose: Budesonide 400 microgm + Formoterol 12 microgm
Administration: Morning and evening with 12-hour interval |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Asthma Diagnosis Confirmed moderate persistent asthma as per GINA guidelines
Treatment Indication Prescribed inhaled corticosteroid or LABA combination for asthma control
Device Competency Demonstrated ability to use both pMDI and DPI correctly during screening
Stability: Clinically stable asthma therapy for at least 4 weeks
Consent Written informed consent (parental consent for minors)
Compliance Ability to attend regular follow-up visits
Residence Local resident for follow-up feasibility
Treatment Response Inadequate control on ICS monotherapy or established need for combination therapy
Reversibility Demonstrated bronchodilator reversibility
|
|
| ExclusionCriteria |
| Details |
Severe Asthma Requiring high-dose ICS/LABA combination or oral corticosteroids
Mild Intermittent Asthma Not requiring regular controller therapy
COPD Overlap: Significant smoking history (more than 10 pack-years) with fixed airflow obstruction
Recent Exacerbation: Within 4 weeks of screening
Other Respiratory Diseases: Active pneumonia, tuberculosis, or other significant lung disease
Pregnancy/Lactation: For female patients of childbearing age
Cardiovascular Contraindications Severe cardiac arrhythmias, recent myocardial infarction
Beta-agonist Sensitivity Known hypersensitivity to formoterol or other LABA
Cognitive Impairment Unable to understand or comply with study procedures
Drug Allergy: Known hypersensitivity to budesonide, formoterol, or device components
Participating Studies Current participation in other clinical trials
Device Preference Strong preference for one device type that would affect compliance
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of budesonide/formoterol combination delivered via pMDI versus DPI on asthma control as measured by change in Asthma Control Test (ACT) scores from baseline to 12 weeks in patients with moderate persistent asthma. |
Screening day -14 to -1
baseline at Day 0
Week 2, 4,8 ,12
Follow up visit at Week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess differences in spirometry parameters between device groups
2.To compare rescue medication usage patterns between groups
3.To evaluate patient satisfaction and device preference scores
4.To assess inhaler technique competency development over time
5.To compare treatment adherence between pMDI and DPI groups
6.To evaluate device-related adverse events and tolerability
7.To assess quality of life changes between treatment groups
8.To analyze baseline factors predicting successful outcomes with each device
9.To evaluate the bronchodilator response with combination therapy
10.To assess time to onset of symptom improvement with each device
|
Screening day -14 to -1
baseline at Day 0
Week 2, 4,8 ,12
Follow up visit at Week 16 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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
|
 BACKGROUND AND RATIONALE
Disease BackgroundAsthma affects approximately 30 million people in India, with prevalence rates of 2-15% across different regions. Punjab shows higher prevalence due to environmental factors including air pollution from agricultural burning and industrial activities. Optimal asthma control in moderate persistent asthma often requires combination therapy with inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). The effectiveness of combination therapy depends significantly on inhaler device selection and patient technique. Combination Therapy RationaleBudesonide/formoterol combination therapy provides:  Synergistic Effect: Enhanced anti-inflammatory action with bronchodilation
 Improved Compliance: Single device for dual therapy
 Better Control: Superior efficacy compared to ICS monotherapy in moderate persistent asthma
 Convenience: Simplified treatment regimen
Study Rationale for Parallel Group DesignUnlike crossover trials, a parallel group design offers several advantages for this inhaler comparison study:  Eliminates Carryover Effects: No risk of treatment effects from the first period influencing the second period, which is particularly important when comparing delivery devices that may have different learning curves.
 Real-World Applicability: Patients in clinical practice use one device consistently, making parallel group results more generalizable to routine care.
 Simplified Protocol: Eliminates washout period considerations and complex crossover statistical analyses.
 Device Familiarity: Allows patients to develop familiarity and technique mastery with their assigned device, reflecting real-world usage patterns.
 Reduced Study Duration: Shorter per-patient participation time improves recruitment and reduces dropout rates.
 12-Week Rationale: Clinical improvement in asthma control with inhaled corticosteroids and LABA combination typically occurs within 4-8 weeks, making 12 weeks sufficient to detect meaningful differences between devices while minimizing patient burden and study costs.
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