Research/Clinical Trial Information
List of our current clinical trials:
Novartis Trial (IPF)
Looking for patients with idiopathic pulmonary fibrosis to participate in a Phase 2 placebo controlled, multiple
dose, exploratory proof of concept study for QAX576, a full human monoclonal antibody.
6 minute walk test of >50 meters at screening
Decline of FVC at least 5% in 12 month period
FEV1/FVC ratio has to be over 60%
FVC greater than or equal to 60%
DLCO >30%
Please contact Sara at slogie@gcrmweb.com for further details
Summit HZC113782 Trial (COPD)
A clinical outcomes study to compare the effect of a once daily dose of Fluticasone Furoate/ Vilanterol (a long
acting beta antagonist)Inhalation powder versus placebo on survival in subjects with stage 2 GOLD COPD and
a history of or increased risk for cardiovascular disease
Ages 40-80
Greater or equal to 10 years cigarette history. Current or former smokers
Excluded: patients with severe heart failure, diagnosis of asthma, or other respiratory
diseases/disorders, COPD exacerbation within 14 days,
Excluded: corticosteroids within 30 days, and patients using oxygen therapy for greater than 12 hours
daily.
Patients will be seen in clinic every 12 weeks.
Patients will be paid for time and travel.
Please contact Linda at ltilme@gcrmweb.com for further details
Ambition Trial (PAH)
Looking for patients with Pulmonary Arterial Hypertension (PAH) to participate in study to compare combination
therapy (ambrisentan and tadalafil) vs. initial monotherapy (ambrisentan or tadalafil).
There is no placebo in this study.
Ages 18-75
Must not have had previous PAH treatment within 4 weeks.
Patients will be paid for time and travel.
Please contact Linda at ltilme@gcrmweb.com for further details
Prospect Registry (PAH)
Looking for patients with Pulmonary Arterial Hypertension (PAH) to participate in registry.
Any and all patients receiving RTS Epoprostenol (Veletri)
Please contact Linda at ltilme@gcrmweb.com for further details.
PAH QuERI Registry (PAH)
Looking at patient management over the course of 3 years. Information will be collected every 6 months using
remote data entry platform.
Patient can be on ANY PAH Meds
Must have dx of PAH (less than 3 years duration)
WHO group One confirmed by RHC (mPAP > 25mm and PCWP £15)
FEV 1 > 50% and
V/Q and/or CT scan excluding thromboembolic etiology
Please contact Linda at email: ltilme@gcrmweb.com for further details
Tyvaso Registry (PAH)
Looking for patients to participate in observational study to assess respiratory tract adverse events in PAH
patients treated with Tyvaso vs. other PAH therapy.
WHO group one
Prescribed any ANY PAH meds
Please contact Linda email ltilme@gcrmweb.com for further details
FOREST ROF-MD-07 (COPD)
Looking for patients with COPD to investigate the efficacy and safety of roflumilast on exacerbation rate in
subjects treated with a fixed dose combination of long-acting beta antagonist and inhaled corticosteroid
At least 40 years old
Stage III and stage IV diagnosis of COPD by GOLD criteria
FEV1/FVC <70%
FEV1 < or equal to 50%
At least 2 documented exacerbations in 12 months
Must be on Advair or Symbicort
Please contact Serteria ssanabria@gcrmweb.com for further details