Nouvelle Clinical Research

Dear colleagues: Nouvelle Clinical Research is are participating in a Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS). I would like to ask you for your support in identifying patients who may be eligible for and willing to participate in this study, and to seek your help to consider referring your patients to me for possible participation. Thanks !

Dear Colleague, I am writing to inform you that Nouvelle Clinical Research is conducting the MARS-17 clinical trial that may be an option for your osteoarthritis (OA) patients. This Phase 2 trial is a placebo-controlled, dose-finding study of GSK3858279 in adult participants with moderate to severe pain due to knee OA. Alleviating the chronic pain associated with OA is a major unmet need. Current therapies such as non-steroidal anti-inflammatory drugs or opioids are either only able to provide limited pain relief or have safety issues/abuse risks that prevent their effective use in this population. C-C class chemokine 17 (CCL17), previously known as thymus and activation regulated chemokine, plays an important role in immune cell migration. Blockade of CCL17 with the monoclonal antibody GSK3858279 offers the potential to alleviate OA-associated chronic pain. Rationale for CCL17 neutralization in OA pain has been generated pre-clinically using in vivo models of inflammatory pain, neuropathic pain, and arthritis. Key eligibility criteria for the MARS-17 clinical trial include the following: ·????????40 to 80 years of age inclusive ·????????Symptomatic OA of the index knee for ≥6 months with a clinical diagnosis of OA ·????????Kellgren and Lawrence score ≥2 on X-ray in the index knee as obtained during screening ·????????Pain score ≥4 and ≤9 by the 11-point Numeric Rating Scale (0-10) for average daily pain intensity over the past 24 hours in the index knee at screening ·????????History of inadequate response, intolerance or contraindication to at least one previous pharmacological therapy for knee OA pain, and who could be considered for treatment with opioids Total duration of the trial is up to approximately 36 weeks for each participant. Please consider referring any patients who may be eligible for further evaluation. To learn more about the trial or to refer a patient, please contac us at 305-712-7867, or via email at [email protected] Thank you for your time and your consideration of the MARS-17 clinical trial for your knee OA patients. Sincerely Alexander Cabrera- CEO

Dear colleagues: Nouvelle Clinical Research is participating in a Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy and Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS). I would like to ask you for your support in identifying patients who may be eligible for and willing to participate in this study, and to seek your help to consider referring your patients to me for possible participation. Study information: This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk. Participants will be seen by me and my staff for study purposes only. All study-related site visits, medical examinations, and study medication will be provided to qualified study participants at no cost. Key Inclusion Criteria: - Male or female participants must be 40 to 80 years of age - A diagnosis of COPD - Current or former smokers with a history of at least 10 pack-years of cigarette smoking. - Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below [(a), (b), (c), or (d)]: a.????Established CV Disease b.?????Combination of CV risk factors: ·????????Hypertension ·????????Diabetes Mellitus ·????????Chronic Kidney Disease ·????????Dyslipidemia ·????????Obesity c.????High risk of CV disease determined using an established CV risk assessment tool. d.?????CT coronary Artery Calcification I am available to consult with you further regarding the eligibility of your patients and to provide additional information. If you have or know of potentially eligible patients, please refer them to our Study Coordinators at email: [email protected] / phone number: 305-712-7867, for further evaluation. I greatly appreciate your assistance with this clinical trial and thank you for your consideration. Yours sincerely, Alexander Cabrera- CEO

Dear Colleague, I am writing to inform you that Nouvelle Clinical Research is conducting the MARS-17 clinical trial that may be an option for your osteoarthritis (OA) patients. This Phase 2 trial is a placebo-controlled, dose-finding study of GSK3858279 in adult participants with moderate to severe pain due to knee OA. Alleviating the chronic pain associated with OA is a major unmet need. Current therapies such as non-steroidal anti-inflammatory drugs or opioids are either only able to provide limited pain relief or have safety issues/abuse risks that prevent their effective use in this population. C-C class chemokine 17 (CCL17), previously known as thymus and activation regulated chemokine, plays an important role in immune cell migration. Blockade of CCL17 with the monoclonal antibody GSK3858279 offers the potential to alleviate OA-associated chronic pain. Rationale for CCL17 neutralization in OA pain has been generated pre-clinically using in vivo models of inflammatory pain, neuropathic pain, and arthritis. Key eligibility criteria for the MARS-17 clinical trial include the following: ·????????40 to 80 years of age inclusive ·????????Symptomatic OA of the index knee for ≥6 months with a clinical diagnosis of OA ·????????Kellgren and Lawrence score ≥2 on X-ray in the index knee as obtained during screening ·????????Pain score ≥4 and ≤9 by the 11-point Numeric Rating Scale (0-10) for average daily pain intensity over the past 24 hours in the index knee at screening ·????????History of inadequate response, intolerance or contraindication to at least one previous pharmacological therapy for knee OA pain, and who could be considered for treatment with opioids Total duration of the trial is up to approximately 36 weeks for each participant. Please consider referring any patients who may be eligible for further evaluation. To learn more about the trial or to refer a patient, please contac us at 305-712-7867, or via email at [email protected] Thank you for your time and your consideration of the MARS-17 clinical trial for your knee OA patients. Sincerely Alexander Cabrera- CEO