Health Condition 1: null- mild to moderate persistent asthma patients
Conditions
Interventions
Intervention1: Group 2: Budesonide (800µg) + Montelukast (10mg)
Group 3: Budesonide (800µg) + Doxiphylline (400mg)
Group 4: Budesonide (800µg) + Roflumilast (500µg)
: Above three combinations are
Montelukast (10mg).
Route: Inhalation and oral.
Duration: 6 months
Intervention6: Budesonide plus Doxofylline: Dose: Budesonide (400mcg)
Doxofylline (400mg). Route: Inhalation and oral. Duration: 6 months.
Intervention7: Budesonide plus Tiotropium: Dose: Budesonide (400mcg)
Tiotropium (18mcg). Route: Inhalation. Duration: 6 months
Control Intervention1: Group 1: Budesonide (800µg) + Salmeterol (100mcg): This will serve as control i.e standard to compare with remaining t
Formoterol (12mcg).
Route: Inhalation.
Duration: 6 months
Sponsors
Dr K Ilango
Eligibility
Inclusion criteria
Inclusion criteria: Patients with mild to moderate persistent asthma and Patients who give their informed consent for the study will be included
Exclusion criteria
Exclusion criteria: ï?? Patients with clinically significant renal, respiratory (other than asthma) cardiac, gastrointestinal, hepatic, endocrine disorders, hematological disorders, cancer or any other concurrent illness or patients who had undergone major surgery ï?? Patients who had unresolved upper respiratory tract infection within past three weeks of the pre study visit ï?? Participants who have received steroid during the month prior to the study ï?? Patients who were known or suspected hypersensitivity to study therapy or excipients ï?? Patients unwilling to give informed consent ï?? Pregnancy and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the long term efficacy of Inhaled Corticosteroid with four different categories of drugs in improvements of pulmonary functions and health related quality of life (HRQoL) in mild to moderate persistent asthmatic patients Timepoint: Two and half years | — |
Secondary
| Measure | Time frame |
|---|---|
| To develop and validate Knowledge, Attitude, Practice (KAP) questionnaire for asthma, To assess the impact of a patient education program in the improvements of pulmonary functions and HRQoL through KAP assessment of patients, To evaluate patient adherence assessment, To assess the safety profile of the study drug combinationsTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr AD Nageswari
Outcome results
None listed