Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01273207
• Date of registration: 07/01/2011
• Prospective Registration: Yes
• Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Public title: Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans
• Scientific title: Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans
• Date of first enrolment: March 2, 2012
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01273207
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Nicole J Gormley, M.D.
• Affiliation: National Heart, Lung, and Blood Institute (NHLBI)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

1. Completed the End of Study visit (week 19) on the initial protocol (Phase II
Trial of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and
Hematopoietic Stem Cell Transplant Recipients for Treatment of Bronchiolitis
Obliterans) in the preceding 12 weeks

2. Patients have shown evidence for a clinical benefit to CIS as evidenced by one or
more of the following:

- Improvement in pulmonary function defined by a 10 percent or more increase in the FEV1
at week 18, confirmed with repeat PFTs at least 1 week apart.

- In patients with progressive disease at study entry on the initial protocol (Phase II
Trial of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic
Stem Cell Transplant Recipients for Treatment of Bronchiolitis Obliterans),
stabilization in pulmonary function, defined as less than a 10 percent improvement in
FEV1 or less than 10 percent decline in FEV1 at week 18, confirmed with repeat PFTs at
least 1 week apart.

- In patients with stable disease (active BOS stable by FEV1 criteria) at study entry on
the initial protocol (Phase II Trial of Cyclosporine Inhalation Solution (CIS) in Lung
Transplant and Hematopoietic Stem Cell Transplant Recipients for Treatment of
Bronchiolitis Obliterans), stabilization in pulmonary function, defined as less than a
10 percent improvement in their FEV1 or less than 10 percent decline in FEV1, and a
decrease in the dose of one or more systemic immunosuppressants by at least 20 percent
(sustained for 3 weeks, excluding adjustments made for target drug levels). * The
criteria for study entry on this extension protocol are not the same as the criteria
for response on the primary protocol to allow for entry of patients on this extension
protocol, which is deriving some clinical benefit, but have not met the full response
criteria as defined in the primary protocol.

EXCLUSION CRITERIA:

1. More than a 12 week gap in study drug administration (CIS)

2. Evidence of uncontrolled, pulmonary infection

3. ECOG performance status greater than or equal to 3

4. Patient pregnant or breast feeding or not willing to continue the use of an approved
method of birth control

5. Life expectancy less than 18 weeks

6. History of hypersensitivity reaction to propylene glycol

7. Documented allergy or intolerance to CIS

8. History of untreated coronary insufficiency, severe cardiac arrhythmias, and/or
uncontrolled hypertension.

9. Serum creatinine greater than 2.5 mg/dl

10. Inability to comprehend the investigational nature of the study and provide informed
consent



Age minimum: 10 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Graft-Versus-Host Disease

Bronchiolitis, Proliferative

Bronchiolitis, Exudative

Bronchiolitis Obliterans

Graft Versus Host Disease

Constructive Bronchiolitis

Intervention(s)

Drug: Cyclosporine Inhalation Solution (CIS)

Primary Outcome(s)

Disease Progression - Decrease in FEV1 or Additional/Increase in Immunosuppressive Therapies [Time Frame: 6 Months]

Disease Stablization - Decrease in FEV1 or Less Than 10% Increase in FEV1 [Time Frame: 6 Months]

Improvement in Lung Function - Increase in FEV1 [Time Frame: 6 Months]

Secondary ID(s)

11-H-0064

110064

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/09/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01273207