Chronic respiratory diseases contributed to 8.96 percent of NCD (noncommunicable diseases) deaths in 2016, with chronic obstructive pulmonary disease (COPD) leading to the most deaths from these conditions (2.93 million deaths).1
At least 1.2 – 2.5 million American patients and 1.3 – 3 million European patients are affected by rare lung diseases. 2 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 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
- Allergic Rhinitis
- Alpha-1 antitrypsin deficiency (AATD)
- Chronic Obstructive Pulmonary Disease (COPD)
- Cystic Fibrosis (CF)
- Interstitial Lung diseases (ILDs), including Idiopathic Pulmonary Fibrosis (IPF)
- Primary Ciliary Dyskinesia (PCD)
- Pulmonary Arterial Hypertension (PAH)
- Upper and Lower Respiratory tract infections (including Respiratory Syncytial Virus [RSV])
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:
- Exercise tests
- Fractional exhaled nitric oxide (FeNo)
- High-resolution computed tomography (HRCT)
- Pulmonary Function Tests (PFTs)
- Provocation tests
- 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. Lancet 2017 - Murray - Global burden of diseases
2. Lancet 2013 – Spagnolo - Rare lung disease and orphan drug development