EUCTR2015-002656-26-BG
Active, not recruiting
Phase 1
A Double-Blind, Randomised, Placebo-controlled, Parallel Group, International, Multi-centre Phase 2 Trial Investigating the Safety and Efficacy of CRD007 in Adult Subjects with Asthma - RSPR-008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- RSPR Pharma AB
- Enrollment
- 160
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent must be obtained before any trial related procedures are performed
- •2\. Age \=18 years old
- •3\. Diagnosis of asthma according to GINA Guidelines (1\)
- •4\. Atopic phenotype
- •5\. Treated with ICS and LABA for at least 12 weeks prior to Visit 1
- •6\. Blood eosinophils \=0\.05\*109/L at Visit 1
- •7\. Demonstration of FEV1 at Visit 1 \= 60% of the predicted value
- •8\. Demonstration of ACQ6 \= 0\.5 and \=2\.5 at Visit 1
- •9\. Reversibility demonstrated at Visit 1 or 2
- •Are the trial subjects under 18? no
Exclusion Criteria
- •1\. Lower respiratory tract infection \<6 weeks prior to Visit 1
- •2\. Smokers
- •3\. Treatment with disallowed medication
- •4\. Pregnant and breast\-feeding female subjects
- •5\. Receipt of any experimental agents within 30 days prior to Visit 1
- •6\. Participation in any other interventional clinical trial during the trial period
- •7\. Significant Medical history
- •8\. Abnormal blood levels
- •9\. Subjects known or suspected of not being able to comply with the trial\-related procedures
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística - CYBERCystic FibrosisFibrosis quísticaMedDRA version: 9.1Level: LLTClassification code 10011763Term: Cystic fibrosis lungEUCTR2008-004699-34-ESAstraZeneca AB50
Active, not recruiting
Not Applicable
A Randomised, Double-Blind, Placebo-Controlled, Parallel-group, Multicentre, 24 week Study to Evaluate the Efficacy and Safety of Transdermal Testosterone (300 mcg/day) in Naturally Menopausal Women with Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen, Oral Non-Conjugated Equine Estrogen, or No Estrogen Therapy - ADOREEUCTR2006-001179-39-DEProcter & Gamble Pharmaceuticals270
Active, not recruiting
Not Applicable
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Long Term (one year) Efficacy and Safety Study of Tiotropium Inhalation Solution 5µg (2 puffs of 2.5µg) Delivered by the Respimat Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD)EUCTR2006-001009-27-HUBoehringer Ingelheim Pharma GesmbH3,000
Active, not recruiting
Not Applicable
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod (GW856553) Tablets Administered Twice Daily compared with Placebo for 24 Weeks in Adult Subjects with Chronic Obstructive Pulmonary Disease (COPD).EUCTR2010-019695-76-EEGlaxoSmithKline Research & Development675
Active, not recruiting
Not Applicable
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre, Long-Term Study to Evaluate the Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 52 Weeks in Adult and Adolescent Subjects with Perennial Allergic RhinitisEUCTR2004-000091-14-LTGlaxoSmithKline736