MERIT Centralized Spirometry Services Case Studies
Whether you’re looking for a centralized spirometry services partner to support an entire multi-phase innovator drug program, or for one Phase III bioequivalence study, MERIT provides the expertise, operational experience, and dedication to help you achieve your development goals. MERIT’s quality overreads, fast turnaround times, and easy-to-reach respiratory therapists will help you move your trial forward. To learn more about MERIT’s respiratory services, read our case studies below.
CASE STUDY 1: PHASE II AND III MULTI-STUDY COPD DRUG DEVELOPMENT PROGRAM
A leading biopharmaceutical company developed a once-daily, nebulized long-acting muscarinic antagonist (LAMA) innovator treatment for moderate to severe chronic obstructive pulmonary disease (COPD). The drug development program included:
- 2 Phase II dose-ranging studies
- 3 Phase III pivotal safety and efficacy trials
RESULTS AND HIGHLIGHTS
- Volume of Spirometry Timepoints: MERIT graded over 338,000 individual timepoints for spirometry over the five studies
- Fast Turn Around Time: There were over 21,000 spirometry sessions for the program with an average turn-around time for overreads of less than 6 hours
- Study Start Up Efficiencies: Over 2,500 subjects were randomized at 295 sites over the course of the four-year program. Efficiencies were gained by MERIT’s strong relationships with trusted sites, accelerating study start up times due to the sites’ familiarity with software and equipment
- FDA Approval: With MERIT as the sponsor’s centralized spirometry partner, the FDA approved the LAMA innovator treatment
CASE STUDY 2: PHASE III BIOEQUIVALENCE STUDY FOR GENERIC ASTHMA TREATMENT
A large generic pharmaceutical company conducted a Phase III clinical trial to demonstrate the bioequivalence (BE) of its generic albuterol sulfate metered dose inhaler using methacholine bronchoprovocation challenges (MBPCs) in adult subjects with asthma.
RESULTS AND HIGHLIGHTS
- SPEED: MERIT supported rapid enrollment and study startup as well as swift study closeout.
- VOLUME OF CHALLENGES: There were 885 total MBPC sessions conducted, a complex and lengthy process, which relied on skilled and effective training provided by MERIT.
- NUMBER OF SPIROMETRY STAGES: MERIT graded 7,295 MBPC spirometry stages throughout the study, ensuring that spirometry was properly performed.
- FDA APPROVAL: With MERIT as the sponsor’s MBPC/centralized spirometry partner, the FDA approved the generic albuterol treatment.
“MERIT was a very valuable partner in our phase 2/3 program as the central spirometry vendor. The oversight they provided to this important component of the program was a key factor in its success. To not use a vendor such as MERIT in a large respiratory program would make executing the studies much more difficult and greatly limit our confidence in the spirometry data.”
-SPONSOR, LEADING BIOPHARMACEUTICAL COMPANY
With MERIT, you benefit from the following:
- Agile team – gain fast and flexible responses from our tenured team
- Collaborative, swift solutions – our qualified respiratory therapists can be contacted with one simple phone call or email
- Easily configurable software – highly customizable workflows that help facilitate rapid study startup and enrollment
- Continuous data access – all study stakeholders have access to the current study data on an ongoing basis
If you’re looking for a spirometry services provider that will value your partnership and make your study a priority, consider MERIT.