Emphysema Clinical Trial
Official title:
A Double-blind, Placebo-controlled Efficacy (as Assessed by Post-bronchodilator FEV1) and Safety Study of RAR Gamma in Subjects With Smoking-related, Moderate to Severe COPD With Emphysema Receiving Concurrent Optimised COPD Drug Therapy.
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. Following the double-blind treatment period, patients will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.
Status | Completed |
Enrollment | 491 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 44 Years and older |
Eligibility |
Inclusion Criteria: - patients of >44 years of age, with >10 pack-year smoking history; - women not of child-bearing potential; - ex-smokers (must have stopped smoking for >=12 months) with clinical diagnosis of emphysema; - willing to be switched to optimal COPD therapy. Exclusion Criteria: - off oral steroids >28 days prior to enrollment; - >2 exacerbations of pulmonary symptoms requiring outpatient treatment, or >1 exacerbation requiring hospitalization, within 12 months prior to screening; - exposure to synthetic oral retinoids in past 12 months; - history of allergy or sensitivity to retinoids. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Bulgaria, Czech Republic, Hungary, Iceland, Israel, Italy, Latvia, Poland, South Africa, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-bronchodilator FEVI | At intervals throughout study, and 2 and 6 months after cessation of study drug | No | |
Secondary | DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation. | At intervals throughout study | No | |
Secondary | AEs, SAEs, retinoid side effects, lab parameters. | Thoughout study | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05825261 -
Exploring Novel Biomarkers for Emphysema Detection
|
||
Completed |
NCT02914340 -
REACH SVS Control Patient Cross-Over Study
|
N/A | |
Completed |
NCT02999685 -
Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients
|
N/A | |
Completed |
NCT02232841 -
Electrical Impedance Imaging of Patients on Mechanical Ventilation
|
N/A | |
Completed |
NCT02238327 -
Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes
|
||
Withdrawn |
NCT01908933 -
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
|
Phase 3 | |
Completed |
NCT01615484 -
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
|
N/A | |
Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
Completed |
NCT01710449 -
Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen
|
Phase 1 | |
Completed |
NCT00475007 -
Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema
|
N/A | |
Suspended |
NCT00523094 -
Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure
|
N/A | |
Recruiting |
NCT00129350 -
Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation
|
Phase 1 | |
Completed |
NCT01953523 -
Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions
|
N/A | |
Completed |
NCT00000621 -
Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)
|
Phase 2 | |
Completed |
NCT00005292 -
Alpha1-antitrypsin Deficiency Registry
|
N/A | |
Recruiting |
NCT04537182 -
Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema
|
N/A | |
Active, not recruiting |
NCT02713347 -
Advancing Symptom Alleviation With Palliative Treatment
|
N/A | |
Recruiting |
NCT04302272 -
STRIVE Post-Market Registry Study
|
||
Completed |
NCT04435327 -
Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
|
||
Completed |
NCT03636347 -
A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.
|
Phase 2 |