Respiratory Clinical Trials and Development
Advancing therapies that help the world breathe easier
Respiratory diseases remain among the leading causes of disability and mortality worldwide. At Syneos Health®, we partner with sponsors to accelerate respiratory clinical trials from early development through launch, combining global scale, scientific rigor and a patient first mindset.
Since 2019, our respiratory teams have supported 340+ projects, 5,000+ sites and 58,000+ patients, helping biopharma move with confidence from clinic to market.
Since 2019:
340+
projects
5K+
sites
58K+
patients
Every respiratory program benefits from our integrated insights, global scale and collaborative mindset. Let’s advance respiratory clinical trials, helping patients breathe easier and live fuller lives.
A Full Service Respiratory CRO with End to End Capabilities
As a respiratory CRO, we integrate clinical operations, medical affairs, regulatory strategy and commercialization to deliver end to end respiratory development across Phase I–IV. Our cross functional experts collaborate across pediatrics, rare disease, infectious diseases & vaccines, cell & gene therapy and oncology to solve the real world challenges unique to global respiratory trials.
Comprehensive Expertise Across Respiratory Indications
Common Respiratory Trials
- Asthma clinical trials
- Chronic obstructive pulmonary disease (COPD) clinical trials
- Chronic sinusitis trials (including secondary indication research for monoclonal antibody assets)
- Allergic rhinitis trials
- RSV clinical trials / RSV infection research
- Pneumonia clinical trials (bacterial/viral)
Rare and Complex Respiratory Trials
- alpha‑1 antitrypsin deficiency (AATD) clinical trials
- Bronchiectasis / non‑cystic fibrosis bronchiectasis (NCFB) clinical trials
- Cystic fibrosis clinical trials
- Idiopathic pulmonary fibrosis (IPF) clinical trials
- Interstitial lung disease (ILD) clinical trials
- Obstructive sleep apnea (OSA) clinical trials
- Pulmonary arterial hypertension (PAH) clinical trials
- Sarcoidosis clinical trials
- Lung cancer clinical trials
Scientific and Operational Excellence in Respiratory Research
Pulmonary Function, Spirometry and Drug-Device Evaluation
We implement spirometry / lung function testingwith standardized workflows, plus inhalation & drug device testing aligned to regulatory expectations and patient safety.
- Biomarkers, Imaging and Advanced Endpoints: Our teams design programs with respiratory biomarkers and imaging endpoints (e.g., CT, MRI, HRCT) to increase sensitivity and decision readiness across obstructive, inflammatory‑ and fibrotic lung diseases.
- Patient-Reported Outcomes and Clinical Outcome Assessments (PRO/COA): We routinely use PRO/COA instruments, including COPD Assessment Test (CAT) and St. George's Respiratory Questionnaire (SGRQ), within ePRO to measure symptom burden and quality of life while improving compliance.
- Digital, Decentralized and Hybrid Respiratory Trials: To reduce burden and expand access, we deliver decentralized respiratory trials and hybrid models with wearables, remote spirometry, eCOA/telehealth and home health logistics.
Integrated Global Infrastructure & Regulatory Expertise
We connect clinical operations with integrated central labs, bioanalysis, imaging core labs and ECG oversight to deliver high quality, decision ready data.
Our platforms provide centralized oversight, enrollment forecasting and trial analytics to improve predictability across global respiratory portfolios.
Dedicated specialists support regulatory strategy and global submissions, aligning endpoint justifications and safety frameworks with evolving agency expectations.
We design studies around the needs of people living with respiratory disease, addressing mobility, symptom variability and caregiver dependencies, because lowering burden improves retention and outcomes.
Focus areas
- Global respiratory site networks and Catalyst sites
- Inclusive enrollment strategies
- Safety‑forward design with eConsent and remote options
- Hybrid/home‑based participation that meets patients where they are
FAQs
Respiratory programs must align device validation, variable endpoints and symptom fluctuations with real‑world feasibility. Our integrated model unifies scientific design, operational execution and patient‑centric methods to de‑risk delivery.
We combine decentralized respiratory trials with telehealth, home visits, eCOA and wearables, plus remote spirometry—reducing travel, broadening access and maintaining data integrity.
We frequently implement CAT and SGRQ in COPD clinical trials to capture symptom burden and quality of life measures valued by investigators and regulators.
Yes. Our teams plan and execute inhalation & drug‑device testing with lab partners and site training to ensure consistent use, quality checks and regulatory alignment.
