Focus Your Pharmaceutical Efficacy Trials

Use the RTube™ Breath Test to Screen Out Patients with
Acid Reflux-Induced Respiratory Symptoms

Acid Reflux Cough Affects Every Efficacy Trial of Respiratory Disease

• 30% - 50% of Asthmatics, COPD patients, and Chronic Coughers volunteering for clinical trials have Acid Reflux Induced respiratory symptoms
• Most of these patients do not have any of the symptoms normally associated with acid reflux disease and are unaware of their condition
• Respiratory symptoms caused by Acid Reflux do not respond to traditional anti-inflammatory medications
• Failure to identify subjects with Acid Reflux-induced respiratory symptoms automatically reduces measured treatment efficacy and dilutes trial results

Description of RTube Breath Test

• Test Type
  Non-invasive measurement of Airway Lining Fluid pH by collection and analysis of Exhaled Breath Condensate (EBC)
• Test Protocol
  • Patient collects six EBC samples during symptomatic episodes and two when asymptomatic using simple take-home collection kit
  • Samples are sent to Respiratory Research central lab for pH analysis in provided shipping carton
  • Laboratory faxes results direct to physician
  • RTubeT Positive is defined as any EBC pH less than 7.4 which is temporally associated with cough
• Test Characteristics
  • 88% Specificity, 100% Sensitivity, 86% Positive Predictive Value for Acid Reflux Cough Sample Profiles
• Sample Profiles
  
  

  RTube™ Profile POSITIVE Multiple low (<7.4) EBC pH values with cough Date Time Symptom EBC pH 12/26/04 1545 Cough 8.3 12/26/04 1745 Cough 5.0 12/26/04 1945 Cough 7.9 12/27/04 1015 Cough 6.0 12/27/04 1215 Cough 7.7 12/27/04 1730 Well 8.1 12/27/04 1930 Well 7.7 12/27/04 2130 Cough 5.8

  RTube™ Profile NEGATIVE All pH values normal Date Time Symptom EBC pH 01/15/05 0945 Well 8.3 01/15/05 1630 Well 8.3 01/15/05 2000 Well 8.3 01/15/05 2145 Well 8.2 01/16/05 1015 Well 8.2 01/16/05 1315 Well 7.8 01/16/05 1800 Well 7.9 01/16/05 2045 Well 8.2

Remove Dilution Effect from Trial Results

• Achieve 50% improvement in efficacy results by screening out subjects with Acid Reflux Cough
• For trials currently under way, add the RTubeT Breath Test for enhanced ability to analyze efficacy results
• The RTubeT Breath Test is accurate, non-invasive, cost-effective, and fast

Contact us today for more information about how the RTubeT Breath Test can help increase the measured efficacy of your molecule and focus your trial results.

Collect Other Biomarkers to Suit Your Research Needs

Exhaled Breath Condensate (EBC) is a rapidly emerging differentiator of patient response to drug therapy. Assays of EBC can be added to drug study protocols as part of the patient selection process, or as outcome variables to better characterize drug effectiveness for prescribing physicians. For example, patients might be enrolled in a study based on elevated levels of exhaled cysteinyl-leukotrienes, or based on poor exhaled breath pH regulation. Some of the benefits you will enjoy as a pharmaceutical researcher are:

1. A complete Exhaled Breath Condensate solution from collection to analysis.
2. RTubes™ are manufactured to stringent specifications and packaged individually in sealed pouches ready for use. No special handling is required for most biomarkers. (Note: there are certain biomarkers, notably nitrogen oxides, for which special handling is recommended. Please see Nitrogen Oxides FAQ for more information.)
3. Low start-up cost; it is easy to scale upward from 25-collection starter kit to continuous longitudinal sampling of thousands of subjects.
4. Collect samples at hundreds of sites for one study, with minimal setup effort.
5. Perfect for large-scale longitudinal studies in any environment: hospitals, clinics, or individual patients in their homes.
6. Samples are stored and protected simply and easily, right inside the collection chamber itself, for safe transport to even a distant laboratory.
7. One central laboratory can analyze samples from hundreds of field locations enabling seamless and robust multi-centered studies while controlling costs.

Important note to researchers: EBC pH is a particularly important measurement in EBC. Measurement of EBC pH is relatively simple. EBC pH is unequivocally in the range of available assay methods. EBC pH is not affected by the duration or temperature of sample storage, nor most other potential technical concerns, making EBC pH a particularly friendly and useful marker of airway/lung disease. EBC collected for pH assays is particularly easy to collect, easy to ship, easy to store and easy to assay. Most importantly, EBC pH reflects acidification of airway lining fluid, a key component of airway inflammation and oxidant stress, and a wonderful marker of acid reflux and aspiration. For more information about the excitement surrounding EBC pH testing, be sure to see our online library which has extensive discussions about EBC pH.