Health Condition 1: J22- Unspecified acute lower respiratory infection
Conditions
Interventions
Intervention1: Inhaled Budesonide + Formoterol combination: Inhaled Budesonide 800 mcg + Formoterol 12 mcg combination twice daily until 2 days without significant cough, maximum for 14 consecutive da
Sponsors
Dr Arpit Kumar Saha
Eligibility
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| i) To compare the requirement for rescue therapy for acute cough in both groups Timepoint: 30 days;ii) To access the nature and severity of adverse events associated with add-on ICS-LABA therapy Timepoint: 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)Timepoint: 30 days | — |
Countries
India
Contacts
Public ContactDr Arnab Saha
Burdwan Medical College & Hospital
Outcome results
None listed