A Multi-Disciplinary Approach to Respiratory Diseases
In 2017, Chronic respiratory Diseases were still the leading causes of morbidity worldwide. A large proportion of the disease burden was attributed to asthma and COPD1. The number of interstitial lung disease and pulmonary sarcoidosis cases nearly doubled from 1990 to 20171.
At least 1.2 – 2.5 million American patients and 1.3 – 3 million European patients are affected by rare lung diseases2. The past decade has seen both a growing interest from the medical community in conducting related respiratory clinical trials and major advances in the specialty of rare diseases2.
Our experts will develop innovative, customized solutions to support your development programs and ensure a timely and quality delivery.
Our Dedicated Respiratory Disease Expert Group
Our dedicated Respiratory Disease expert group and clinical operations team have years of experience working on respiratory studies with global coverage (Europe, the Americas and Asia Pacific). Our teams have extensive therapeutic and regulatory experience across the broad spectrum of indications:
- Acute Bronchiolitis (RSV)
- Allergic Rhinitis
- Alpha-1 Antitrypsin Deficiency (AATD)
- Chronic Obstructive Pulmonary Disease (COPD)
- Chronic Rhinosinusitis (CRS)
- Cystic Fibrosis (CF)
- Interstitial Lung Diseases (ILDs), including Idiopathic Pulmonary Fibrosis (IPF)
- Non-Tuberculous Mycobacterial Pulmonary Diseases (NTM-PD)
- Primary Ciliary Dyskinesia (PCD)
- Pulmonary Arterial Hypertension (PAH)
- Upper and Lower Respiratory Tract Infections
Thanks to our broad expertise in all of these respiratory indications, we have experience with most of the study drug formulations targeting the lungs (metered dose inhalers [MDI], dry powder inhalers [DPI], Nebulization), and in most specific investigations for lung disorders:
- Bronchoscopy and Bronchoalveolar Lavage (BAL)
- Cough Monitoring
- Exercise tests
- Fractional exhaled nitric oxide (FeNo)
- High-resolution computed tomography (HRCT)
- Nasal and Bronchial Provocation tests
- Nasal endoscopy
- Pulmonary Function Tests (PFTs)
- Provocation tests
- Pulmonary Function Tests (PFTs), including standard spirometry, reversibility test, plethysmography and Lung Clearance Index (LCI)
- Specific Health-Related Quality of Life measures (HrQoLs)
- Sputum Induction
Many indications in respiratory disorders involve neonatal and pediatric indications (asthma, allergic rhinitis, PAH, CF, PCD, acute bronchiolitis), and we have set up an expert network consortium in Pediatrics supporting these indications.
We have also set up a consortium for Rare Diseases and provide support in developing specific training to support customers, sites and teams.
1. Respiratory Research 2020 - Min Xie - Trends in prevalence and incidence of chronic respiratory diseases from 1990 to 2017
2. Lancet 2013 – Spagnolo - Rare lung disease and orphan drug development