Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: Aerobika OPEP BID 10 min for 1 year plus Standard of Care
: This device creates positive pressure with oscillation
thus secretion gets dislodged.Hence it would be easier for Bronchiectasis patient to cough out.
The device is used for enrolled bronchiectasis patients along with standard of care.
Control Interventio
Sponsors
Trudell Medical International
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosis of bronchiectasis by HRCT of the chest 2.Documented Gram-negative bacterial infection of the respiratory tract 3.At least one documented bronchiectasis exacerbation requiring systemic antibiotics or systemic corticosteroids within the 12 months prior to screening 4.Clinically stable for at least 4 weeks prior to randomization 5.Able to perform and reproducibly complete spirometry according to ATS ERS criteria 6.Provision of written informed consent prior to any study specific procedure 7.Patients have never used any kind of OPEP device in the past.
Exclusion criteria
Exclusion criteria: 1.History of pneumothorax within the preceding 3 months or known bullous emphysema constituting a contraindication to positive pressure techniques 2.Massive hemoptysis within the preceding 3 months 3.Significant neuromuscular or cognitive impairment precluding safe and effective device use as judged by the investigator 4.Current enrolment in another interventional randomized control trial 5.Pregnancy or planned pregnancy during the study period or breastfeeding 6.Any other medical condition that in the opinion of the investigator would prevent safe participation or confound study interpretation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bronchiectasis Health QuestionnaireTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Exacerbation Outcomes 2.Physiological Outcomes 3.Patient Reported Symptom Outcomes 4.Safety OutcomesTimepoint: 6 months and 12 months | — |
Countries
India
Contacts
Public ContactDr Raja Dhar
The Calcutta Medical Research Institute
Outcome results
None listed