Health Condition 1: J459- Other and unspecified asthma
Conditions
Interventions
None listed
Sponsors
Maheshwari Pharmaceuticals (I) Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age and Gender: Adults aged between eighteen and sixty years, of either gender. 2. Asthma Diagnosis: A documented clinical diagnosis of bronchial asthma for at least six months prior to enrollment. 3. Disease Severity: a. Mild to moderate asthma as defined by spirometry: i. Mild asthma: Post-bronchodilator FEV1 greater than or equal to eighty percent of the predicted value. ii. Moderate asthma: Post-bronchodilator FEV1 between sixty percent and eighty percent of the predicted value. b. An Asthma Control Questionnaire (ACQ) score in the range of one point zero to two point five, indicating partially controlled symptoms that require intervention. 4. Stability on Standard Care: Subjects must be on a stable regimen of standard of care for asthma management prior to enrollment. 5. Informed Consent: Ability and willingness to provide written informed consent before any study-related procedures. 6. Compliance: Willingness to comply with all the study procedures including scheduled visits and treatment administration.
Exclusion criteria
Exclusion criteria: 1. Severe Respiratory Conditions: Subjects with severe bronchiectasis, chronic obstructive pulmonary disease (COPD), or other significant respiratory disorders that might confound study results, (e.g., FEV1 less than 60 percent predicted). 2. Infectious Diseases: Presence of known chronic, contagious infectious diseases such as active tuberculosis, hepatitis B or C, or HIV. 3. Nasal or Airway Structural Abnormalities: Subjects with significant anatomical abnormalities (e.g., large nasal polyps or marked septal deviation) that could interfere with respiratory assessments. 4. Recent Participation in Other Trials: Participation in another clinical trial or use of any investigational product within a specified washout period prior to screening. 5. Psychiatric Conditions: A history of psychiatric illness that may compromise compliance or interfere with the interpretation of study outcomes. 6. Pregnancy and Lactation: Pregnant or lactating women, due to the unknown effects of the investigational product on fetal or neonatal development. 7. Other Medical Conditions: Any other condition deemed by the investigator to potentially interfere with study assessments or the safe participation of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Lung Function Improvement: Change in spirometry parameters, specifically Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC), from baseline to Day 90. A clinically meaningful improvement is defined as an increase of at least 12% and 200 mL in FEV1 from baseline. 2. Symptom Reduction: Change in the frequency and severity of asthma-related symptoms (e.g., cough, wheezing, chest tightness, and breathlessness) as recorded in subject diaries and assessed by clinician evaluations from baseline to Day 90. 3. Rescue Inhaler Usage: Reduction in the frequency of rescue inhaler use over the 90-day treatment period, indicating improved symptom management.Timepoint: Day 0, 30, 60, 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Asthma Control: Change in Asthma Control Questionnaire (ACQ) scores from baseline to Day 90. A decrease of 0.5 or more is considered the minimal clinically important difference. 2. Quality of Life: Improvement in quality of life as measured by the SF-36 health survey from baseline to Day 90.Timepoint: Day 0, 30, 60, 90 | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed