Efficacy/Safety of HA Inhalation Solution for Hereditary Emphysema in Patients With Alpha-1 Antitrypsin Deficiency

Completed · Phase 2 · Has a placebo group

Conditions studied: Emphysema, Alpha 1-Antitrypsin Deficiency

In brief

The purpose of the study is to evaluate the safety and efficacy of administering repeated doses of Hyaluronic Acid Inhalation Solution to subjects with Emphysema that have Alpha-1-Antitrypsin deficiency

Key facts

Study ID

NCT03114020

Run by

Gerard Turino

People needed

27

Starts

2017-03-22

Expected to finish

2019-11-12

Last updated by the study team

2020-04-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to provide written informed consent and comply with study requirements
• Men or women aged 18 through 80 years at the time of consent
• Diagnosis of emphysema at screening consistent with National Institutes of Health guidelines 19 GOLD COPD classification stages I, II or III
• Evidence of emphysema on radiographic imaging.
• A ratio of pre-bronchodilator FEV1 to forced vital capacity (FVC) of ≤ 80% at screening
• FEV1 ≥ 30% and ≤ 79% (post-bronchodilator) of predicted normal at screening
• Clinical laboratory tests (complete blood count, serum chemistry, and urinalysis) within normal limits or clinically acceptable to the PI and sponsor at screening
• Women of childbearing potential and men who are sexually active must agree to use an adequate method of contraception (oral contraceptives, depot progesterone, condom plus spermicidal, or IUD) during the study and for 1 month after the final dose of study drug.
• Evidence of alpha-1 antitrypsin deficiency (AATD) with any genotype except PiMZ deficiency. Individuals with PiMZ deficiency are not allowed in the study.
• Patients must have stopped using Intravenous alpha-1 antitrypsin protein (AAT) augmentation therapy at least 3 months before entering study.

You may not qualify if…

• Subjects with measured DLCO of ≤ 35%, or unable to perform a reproducible DLCO
• Subjects unable to perform 3 reproducible spirometry tests after 8 attempts
• Upper or lower respiratory tract infection within 2 weeks prior to screening and baseline (day1)
• Presence of clinically relevant abnormality on chest x-ray (other than evidence of emphysema) within the previous 12 months
• Use of supplemental oxygen therapy
• Requirement for ventilator support within the last year
• Exacerbation requiring treatment with systemic corticosteroids within the last 3 months
• History of lung transplant or liver transplant.
• Presence of clinically relevant abnormality on electrocardiogram (ECG)
• Any medical condition that, in the investigator's judgment, would compromise study participation or the evaluation of the study drug
• Women who are pregnant or breastfeeding
• Receipt of an investigational drug within 30 days prior to screening
• Patients who are current smokers or have smoked within the last 3 months -

Where it is running

• University of Miami Hospital — Miami, Florida, United States
• Pulmonary Health Physicians, PC — Fayetteville, New York, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Health Science Center — Tyler, Texas, United States
• Medical College of Wisconsin / Froedtert Hospital — Milwaukee, Wisconsin, United States
• Inspiration Research Limited — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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