Spotlight on Respiratory Trials: CROS NT Published in COPD Study Results

respiratory COPD inhaler trialsCROS NT recently co-authored a paper with CrossMark on the outcome of a trial studying the long-term effects of inhaled corticosteroids on sputum bacterial and viral loads in COPD.

CROS NT Chairman and biostatistician by background, Paolo Morelli, was a co-author on this paper. Statistician, Giulia Zardi, supported with statistical analysis elaboration and revision.

This was a proof-of-concept prospective, randomized, open-label, blinded endpoint study. Sixty patients with stable moderate COPD were randomized to receive one inhalation twice daily. The primary outcome was the change of sputum bacterial loads over the course of treatment.

Consecutive COPD patients were screened for eligibility according to the Global Initiative for Chronic Obstructive Lung Disease definition. These patients were chosen among those visiting the outpatient clinic of the Research Centre on Asthma and COPD at the University of Ferrara in Italy.

Long-term effects of inhaled corticosteroids on sputum bacterial and viral loads in COPD



Are inhaled corticosteroids increasing the “load” for some patients with COPD?




15% of the world’s population suffer from a respiratory disease.

Asthma and chronic pulmonary disease (COPD) are the two largest indications being researched in respiratory clinical trials.

By centralizing data for a particular respiratory product, Sponsors can achieve a series of benefits that will lead to a much smoother and cost efficient clinical trial program. The biometrics team are able to align objectives and ensure continuity. Other benefits include uniform traceability of data, one set of biometrics SOPs, centralization of study metrics and study reports and quicker integrated summaries.

In terms of database, CRF and TFL standards, it may not be necessary to pay for design, build and table programming for CRF pages such as demography, medical history, physical examination, local laboratory, vital signs, ECG, concomitant medications, adverse events, study conclusion and patient’s VAS. Such pages will often exist already within a global library, needing only minor alteration, from a previous study.

Respiratory is a particular area of expertise for CROS NT. We can provide the following services to improve the efficiency of respiratory clinical trials:

  • Validated database structure and edit checks
  • Standard lower and upper bound for specific parameters
  • Validated SDTM and ADaM formats
  • ePRO solutions (and data integration with an EDC system)
  • Possibility to integrate images from source data

CROS NT supports Sponsors of respiratory drug and device trials with a full package including:

  • Long-standing partnerships with sites in UK, US and mainland Europe
  • Successful clinical trial recruitment with patient and healthy volunteer databases
  • Strong medical writing experience in respiratory protocols, CSRs, safety narratives
  • Data standardization including CDISC CRF pages and datasets
  • Study design and feasibility
  • Expert biostatistics, programming and data management services