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CTRI Number  CTRI/2024/09/073863 [Registered on: 12/09/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study on the Effectiveness of an Inhaled Budesonide-Formoterol Combination for Treating Acute Cough After Infections: A Double-Blind Trial with Placebo Comparison 
Scientific Title of Study   Efficacy of Inhaled Budesonide-Formoterol Combination in Post-Infectious Acute Cough A Multicentric Double Blind Randomized Placebo Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BREATHE PROTOCOL , VER -1 , DATE 24.04.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arpit Kumar Saha 
Designation  Assistant professor  
Affiliation  Shantiniketan Medical college  
Address  Department of Microbiology ,Asst. proff room , block 2 ,2nd floor Gobindapur, Muluk, Bolpur, West Bengal 731204

Birbhum
WEST BENGAL
731204
India 
Phone  7501166640  
Fax    
Email  arpitsaha21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arnab Saha 
Designation  Assistant professor 
Affiliation  Burdwan Medical College & Hospital 
Address  Derpartment Of Respiratory Medicine Burdwan Medical College and Hospital Shyamsayar(West), Rajbati Purba Bardhaman  Pin 713101

Barddhaman
WEST BENGAL
713101
India 
Phone  9477290413  
Fax    
Email  dr.arnab.saha@gmai.com  
 
Details of Contact Person
Public Query  
Name  Dr Arnab Saha 
Designation  Assistant professor 
Affiliation  Burdwan Medical College & Hospital 
Address  Derpartment Of Respiratory Medicine Burdwan Medical College and Hospital Shyamsayar(West), Rajbati Purba Bardhaman  Pin 713101

Barddhaman
WEST BENGAL
713101
India 
Phone  9477290413  
Fax    
Email  dr.arnab.saha@gmai.com  
 
Source of Monetary or Material Support  
Cipla Ltd, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel Mumbai 400 013,India Maharashtra. Cipla ltd will supply of both the placebo and active drug in form of the Breath Actuated Inhaler devices 
 
Primary Sponsor  
Name  Dr Arpit Kumar Saha 
Address  Block 2 , 2nd Floor , Gobindapur, Muluk, Bolpur, West Bengal 731204 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arpit Kumar Saha   Ma Medicine House   Rampurhat Hospital 2 no gate , Rampurhat ,west bengal , pin 731202
Birbhum
WEST BENGAL 		 7501166640

arpitsaha21@gmail.com 
Dr Arnab Saha  Ray Clinic   1, Chowdhury Para Ln , Baruipara,Ramrajatala, HOwrah , west Bengal ,Pin 711104
Haora
WEST BENGAL 		 9477290413

dr.arnab.saha@gmail.com 
Dr Soumyadeep Ghosh  shantiniketan Medical College   Gobindapur, Muluk, Bolpur, West Bengal 731204
Birbhum
WEST BENGAL 		 9593754343

soumya.joteram@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Indira IVF Hospital Ethics Committee   Approved 
Indira IVF Hospital Ethics Committee   Approved 
Indira IVF Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inhaled Budesonide + Formoterol combination   Inhaled Budesonide 800 mcg + Formoterol 12 mcg combination twice daily until 2 days without significant cough, maximum for 14 consecutive days + Standard of Care  
Comparator Agent  Inhaled Placebo therapy   Inhaled Placebo therapy twice daily until 2 days without significant cough, maximum for 14 consecutive days + Standard of Care  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  •Clinically diagnosed as post-infectious acute cough (duration of cough lasting less than 21 days)
•Minimum duration of cough / day of symptoms should be 7 days
•Having Acute Cough Symptom Score (CSS)10 more than ≥ 4 at inclusion
•Age between 18-65 years, all sexes
•Willing to give written informed consent
 
 
ExclusionCriteria 
Details  •Those having at least one documented episodes of asthma requiring systemic (i.e., oral, intravenous, or intramuscular) or inhalational corticosteroids in past
•Previous history suggestive of bronchial asthma (like history of previous wheezing or episodic shortness of breath)
•Present episode of Pneumonia: Culture positive or X ray Chest showing consolidation
•Other parenchymal lung disorders as depicted from history or seen in X ray Chest
•Past H/O atopy and prominent allergic rhinitis
•History or pre-existing evidence of any lung disease
•Any previous history of exertional shortness of breath with MMRC scale more than or equal to 1
•History taking and clinical examination revealing other chronic diseases presenting with cough e.g. congestive cardiac failure, kidney disease with volume overload, gastro-oesophageal reflux requiring treatment
•Evidence showing immunocompromised status
•Evidence of any significant organic dysfunction
•Patients already on inhalational steroid or systemic steroid for existing systemic disease
•Uncontrolled systemic disease or pregnancy based on initial history
•Those receiving peripheral acting cough suppressants, central acting cough suppressants, or bronchodilator cough syrup for more than last two days will be excluded
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
i) To compare the reduction in mean cough score from baseline evaluated at 4th day, 8th day and 14th day of therapy in the add-on inhaled ICS+ LABA group versus the add-on inhaled placebo group
ii) To compare the overall improvement in quality-of-life from baseline, at 14 days post-treatment initiation, in both groups
 		 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
i) To compare the requirement for rescue therapy for acute cough in both groups
 		 30 days  
ii) To access the nature and severity of adverse events associated with add-on ICS-LABA therapy
 		 30 days 
iii) To compare the requirement for hospital admissions for the ongoing episode of post-infectious acute cough, in both groups (when followed till 30 days of cough-related symptom onset)  30 days 
 
Target Sample Size   Total Sample Size="158"
Sample Size from India="158" 
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   Phase 4 
Date of First Enrollment (India)   23/09/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [arpitsaha21@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study is a multi-centric, double-blind, randomized controlled trial aiming to assess the efficacy of an inhaled LABA-ICS (Long-Acting Beta-Agonist and Inhaled Corticosteroid) combination in patients suffering from post-infectious acute cough. A total of 158 patients will be enrolled and randomly assigned in a parallel-arm design to receive either the inhaled LABA-ICS combination or a placebo, in addition to the standard of care. The trial’s primary outcomes are the reduction in mean cough score from baseline, evaluated on the 4th, 8th, and 14th days of therapy, and the overall improvement in quality of life at 14 days post-treatment initiation, comparing the LABA-ICS group to the placebo group. This investigator-initiated academic trial aims to determine whether the LABA-ICS combination offers greater symptomatic relief and enhanced quality of life for patients with post-infectious acute cough. 
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