Adult Asthma Clinical Trial

1. Adult Asthma Clinical Trial A comprehensive framework for conducting rigorous asthma research in adult populations, emphasizing patient safety, data integrity, and regulatory compliance.

2. Study Overview & Primary Objectives Trial Design Phase III, randomized, double-blind, placebo-controlled multicenter study evaluating novel bronchodilator therapy in adults with moderate-to-severe persistent asthma. Primary Endpoint Change from baseline in forced expiratory volume (FEV1) at 12 weeks, with secondary endpoints including exacerbation rate, quality of life scores, and safety parameters.

3. Patient Eligibility Criteria 1 2 3 Age & Diagnosis Disease Severity Exclusion Factors Adults 18-65 years with physician-diagnosed asthma for ≥12 months and documented reversibility on spirometry (≥12% and 200mL FEV1 improvement). ACQ score ≥1.5, pre-bronchodilator FEV1 40-80% predicted, and requiring medium-to-high dose ICS with or without LABA for ≥3 months. Current smokers, smoking history >10 pack-years, COPD diagnosis, severe uncontrolled comorbidities, or exacerbation requiring systemic corticosteroids within 4 weeks.

4. Trial Timeline & Study Visits 1 Screening Period Week -2: Informed consent, eligibility assessment, baseline spirometry, medical history, and washout of prohibited medications. 2 Randomization Day 1: Baseline assessments, questionnaires, randomization to treatment or placebo arms in 1:1 ratio using IVRS system. 3 Treatment Phase Weeks 4, 8, 12: Regular monitoring visits with spirometry, symptom assessment, adverse event recording, and medication compliance checks. 4 Study Completion Week 12: Final assessments including complete pulmonary function tests, safety labs, and quality of life questionnaires.

5. Treatment Protocol & Dosing Investigational Product Novel long-acting muscarinic antagonist (LAMA) delivered via dry powder inhaler, administered twice daily at standardized times (±2 hours). Background Therapy Patients continue stable doses of inhaled corticosteroids. Rescue albuterol permitted as needed, with usage tracked via electronic diary. Active Arm Investigational LAMA 5mcg BID + standard ICS therapy Placebo Arm Matching placebo inhaler BID + standard ICS therapy

6. Key Assessment Measures 01 Pulmonary Function Pre- and post-bronchodilator spirometry at each visit, measuring FEV1, FVC, and FEV1/FVC ratio per ATS/ERS guidelines. 02 Symptom Control Asthma Control Questionnaire (ACQ-6), daily symptom scores, nocturnal awakening frequency, and rescue medication usage. 03 Quality of Life Asthma Quality of Life Questionnaire (AQLQ) administered at baseline, week 6, and week 12 to assess functional impact. 04 Safety Monitoring Vital signs, laboratory parameters (CBC, chemistry panel), ECG, adverse event documentation, and serious adverse event reporting.

7. Data Collection & Management Electronic Data Capture Source Documentation Data Security All data entered into validated EDC system with real-time edit checks, audit trails, and query management to ensure data quality and regulatory compliance. Complete source data verification for critical variables, with 100% SDV for primary endpoint and informed consent, plus 25% SDV for secondary endpoints. HIPAA-compliant data management with encrypted transmission, role-based access controls, and regular database backups to secure servers.

8. Safety Monitoring Framework Adverse Event Reporting All AEs documented from informed consent through 30 days post-treatment. Severity graded per CTCAE v5.0, with relationship to study drug assessed by investigators. Data Safety Monitoring Independent DSMB reviews unblinded safety data quarterly. Pre-specified stopping rules for excess SAEs, with interim efficacy analysis at 50% enrollment. Critical Safety Parameters: Cardiovascular events, respiratory infections, paradoxical bronchospasm, and hypersensitivity reactions require immediate reporting to medical monitor within 24 hours.

9. Statistical Analysis Plan 220 12 15 Target Enrollment Study Duration Clinical Sites Sample size provides 90% power to detect 150mL FEV1 difference (α=0.05, two-sided) Weeks of active treatment with comprehensive endpoint assessment Multicenter trial across academic and community pulmonology practices Analysis Populations • Intent-to-Treat (ITT): All randomized patients, primary efficacy analysis • Per-Protocol (PP): Patients completing study with no major protocol deviations • Safety: All patients receiving ≥1 dose of study medication Primary analysis uses MMRM for repeated measures with baseline FEV1, treatment, visit, and treatment-by-visit interaction as fixed effects.

10. Regulatory & Ethical Compliance IRB/EC Approval GCP Standards Protocol, informed consent, and recruitment materials approved by institutional review boards prior to enrollment. Annual continuing reviews and prompt reporting of protocol amendments. Trial conducted per ICH-GCP guidelines, with comprehensive investigator training, regular monitoring visits, and site qualification assessments ensuring quality standards. Regulatory Oversight FDA IND application with annual reports. Trial registered on ClinicalTrials.gov. Results disseminated via peer-reviewed publication and regulatory submission within 12 months of completion.

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