Phase 4 N=30 Treatment

Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)

Complication of Transplanted Lung

Bottom Line

View on ClinicalTrials.gov: NCT01469364 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Nov 2015

Primary outcome: Primary: Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry — -0.04 Liter — p=0.2030

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Aztreonam Lysine for Inhalation (AZLI) (Drug); Status Post Lung Transplant (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry	-0.02	0.2527
PRIMARY Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry	-0.02	0.2527
PRIMARY Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1	-1.52; 0.78	0.34
PRIMARY Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 and Month 5.	1.62; -1.24	0.09
PRIMARY Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1	0.82	0.56
PRIMARY Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.	0.15	0.68
PRIMARY Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.	-0.015	0.7454
PRIMARY Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1	-0.025	0.9638
SECONDARY Change in FEV1 Off AZLI Therapy	—	—
SECONDARY Change in HRQOL Off AZLI Therapy.	—	—
SECONDARY Among Patients Colonized With Pseudomonas Aeruginosa, Change in Infection Burden as Measured by the Culture Final Report (0,1+, 2+, 3+, 4+) of in Pseudomonas Aeruginosa Sputum or Bronchoalveolar Fluid.	4; 0	—
SECONDARY Bronchoalveolar Lavage Fluid (BALF) Neutrophilia After Treatment, When Performed as Part of Clinical Care (SOC).	7.80	—

Summary

This study is a pilot two- center study to determine if aztreonam lysine for inhalation AZLI can be safely and self-administered in lung transplant recipients with newly diagnosed bronchiolitis obliterans syndrome, grade 1 (BOS) and obtain pilot data regarding its effect on lung function in order to appropriately design and power a larger multicenter randomized study. The hypothesis is that AZLI is a safe and effective treatment for declining lung function in lung transplant recipients with early stage BOS.

Eligibility Criteria

Inclusion Criteria

Adult (18 or older at the time of transplant) male or female
Cadaveric first lung transplant recipient, single or bilateral; or multi-organ lung transplant recipient.
Current FEV1 66-80% of posttransplant baseline FEV1, and meets all criteria for BOS 1 as defined by the International Society of Heart and Lung Transplantation.
Onset of BOS 1 within twelve months of screening

Exclusion Criteria

Known allergy to aztreonam
Retransplant
Pediatric patients
Live lobar transplant recipients
Inability to provide informed consent.
Patients with advanced BOS (grades 2, 3) or established BOS >6 months
Pregnant Women

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01469364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.