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Immunosuppressant

Aerosol Cyclosporine in Chronic Obstructive Pulmonary Disease (COPD)

Phase 1
Waitlist Available
Led By Michael Donahoe, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions

Summary

This is a randomized, double-blinded, Phase I dose escalation-deescalation protocol (DEP) of cyclosporine inhalation solution in patients with Gold Stage III chronic obstructive pulmonary disease. The purpose of the study is to evaluate the safety and effectiveness of aerosolized Cyclosporine in treating COPD. The specific aims of the study are: 1. To identify the short term (28 day) safety profile of CyIS immunotherapy in severe COPD (GOLD III) patients with particular attention to airway reactivity and infection risk. 2. To identify the pharmacokinetic-pharmacodynamic relationship of CyIS using peripheral blood markers of an adaptive immune response as endpoints in subjects with severe COPD (GOLD III) treated short-term. Subjects between 45 and 70 years of age with a confirmed diagnosis of COPD, Gold Stage III, and meet all the study requirements, will be enrolled in this study. A total of 24 subjects of either sex will be enrolled in this study. A total of 4 subject cohorts (n=6) will participate in the protocol.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 3 trial • 446 Patients • NCT01820572
21%
Diarrhoea
20%
Nasopharyngitis
17%
Urinary tract infection
14%
Cough
13%
Hypertension
12%
Headache
10%
Fatigue
10%
Oedema peripheral
10%
Bronchitis
10%
Arthralgia
9%
Kidney transplant rejection
9%
Pyrexia
9%
Blood creatinine increased
8%
Upper respiratory tract infection
8%
Back pain
7%
Nausea
7%
Dizziness
5%
Pain in extremity
5%
Vomiting
5%
Oropharyngeal pain
5%
Abdominal pain
5%
Basal cell carcinoma
4%
Insomnia
3%
Tremor
3%
Urosepsis
2%
Musculoskeletal pain
2%
Squamous cell carcinoma of skin
2%
Acute kidney injury
2%
Sepsis
2%
Pneumonia
1%
Bowen's disease
1%
Congenital cystic kidney disease
1%
Chest pain
1%
Herpes zoster
1%
Extremity necrosis
1%
Pancreatitis
1%
Bacterial pyelonephritis
1%
Influenza
1%
Osteomyelitis
1%
Deep vein thrombosis
1%
Overdose
1%
Squamous cell carcinoma
1%
Proteinuria
1%
Osteoarthritis
1%
Acute myocardial infarction
1%
Atrial fibrillation
1%
Coronary artery disease
1%
Myocardial infarction
1%
Renal graft infection
1%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept
CNI-Based Regimen

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CyclosporineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be randomly assigned to Cyclosporine or placebo, in a ratio of 2:1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclosporine
FDA approved

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,790 Previous Clinical Trials
16,359,795 Total Patients Enrolled
Michael Donahoe, MDPrincipal InvestigatorUniversity of Pittsburgh
3 Previous Clinical Trials
52 Total Patients Enrolled
~0 spots leftby Dec 2025