At Worldwide Clinical Trials, our medical experts understand that the commercial viability of therapeutics for chronic respiratory disorders is influenced by a range of factors, including perceived value and therapeutic novelty. This has particular relevance to illnesses with established pharmacotherapy such as asthma and COPD. Worldwide Clinical Trails’ philosophy of employing expert clinical trial methodology, combined with our commitment to innovation, helps us deliver data relevant to multiple stakeholder perspectives and appropriate to each phase of your drug or device development.

Relationships and Experience

Our close relationships with opinion leaders and practitioners in respiratory medicine ensure that complex study objectives and eligibility criteria evolve into a plan that delivers reliable metrics, consistently met timelines, and impeccable data. Our team has success in overcoming the unique challenges in conducting trials in respiratory disorders, including for example, determining the allergic status of patients with asthma and managing co-morbidity often associated with COPD.

Worldwide has completed more than 100 studies related to respiratory disorders since 2008. For these studies, Worldwide Clinical Trials provided multiple services, including clinical monitoring or project management services across all phases. We have completed trials with a wide range of therapeutic interventions, such as corticosteroids, bronchodilators, and antibiotics, as well as kinase inhibitors. Our respiratory disorder experience includes:

  • Acute and chronic sinusitis
  • Allergic rhinitis (seasonal and perennial)
  • Asthma (mild to severe)
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Cystic Fibrosis
  • Emphysema
  • IPF (Idiopathic Pulmonary Fibrosis)
  • Influenza
  • Malignant neoplasm of trachea, bronchus and lung
  • Perennial and seasonal rhinitis
  • Pneumonia
    • Community-Acquired Bacterial Pneumonia* (CAP)
    • Hospital-Acquired Bacterial Pneumonia (HAP) or Nosocomial Pneumonia
  • Upper/Lower Respiratory Tract Infections

Respiratory Study Design, Execution, and Analysis

Worldwide has participated in the design, execution, or analysis for more than 100 trials in respiratory diseases and disorders since 2008. For these studies, we provided a wide range of services, such as clinical monitoring or project management services. Of these, the majority were in Chronic Obstructive Pulmonary Disease (16 studies), Asthma (14 studies), and Cystic Fibrosis (10 studies). Our experts have managed studies with a variety of therapeutic interventions, such as corticosteroids, bronchodilators, antibiotics, and kinase inhibitors.

Capabilities of the Worldwide clinical operations staff specific to respiratory diseases and disorders include:

  • Extensive training on both medical and operational aspects of respiratory disorders.
  • Experience in various scales and measures commonly used in respiratory diseases, including measures of pulmonary function (e.g., FEV1 and forced vital capacity (FVC) evaluated via spirometry), and Patient Reported Outcome instruments (e.g., St George’s Respiratory Questionnaire (SGRQ) and Quality of Life Short Form 36 (SF-36)).
  • Success in overcoming unique challenges in conducting trials in respiratory diseases, for example, understanding the importance of the use of centralized spirometry and operational implications.
  • Extensive practical knowledge of the impact of local clinical management practices and EC/IRB conventions on study design and implementation (e.g., access to principal investigators, knowledge regarding standard of care, and local reimbursement conventions).
  • Completion of numerous phase I clinical trials for steroid inhalation compounds, as well as both short-acting and long acting bronchodilators
  • Expertise in the area of bioequivalence, requiring very accurate and consistent dose administration and multiple time-point blood sample collection for pharmacokinetic (PK) assessments.

Unique Assessments

  • Spirometry
  • Inflammatory Mediators in Sputum
  • Methacholine/AMP Hyper-responsiveness
  • Six Minute Walk Test (6MWT)
  • St. George’s Respiratory Questionnaire
  • Cough Visual Analogue Scale (VAS)