Trial Outcomes & Findings for Study of Mitomycin-C Application in Laryngotracheal Stenosis (NCT NCT01523275)
NCT ID: NCT01523275
Last Updated: 2019-05-22
Results Overview
Length of time between surgeries for laryngotracheal stenosis during the study
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
24 months
Results posted on
2019-05-22
Participant Flow
Recruited from the UCSF Voice and Swallowing Center clinic from August 1, 2012 to February 1, 2018
Participant milestones
| Measure |
Mitomycin C
Endoscopic dilation with topical mitomycin C
|
Saline
Endoscopic dilation with topical saline
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
9
|
|
Overall Study
COMPLETED
|
4
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Mitomycin C
Endoscopic dilation with topical mitomycin C
|
Saline
Endoscopic dilation with topical saline
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Study of Mitomycin-C Application in Laryngotracheal Stenosis
Baseline characteristics by cohort
| Measure |
Saline
n=9 Participants
Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of isotonic saline in the radial incisions.
Saline application: Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention.
|
Mitomycin-C
n=6 Participants
Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of MMC in the radial incisions.
Mitomycin -C: Topical mitomycin-C at a dosage of 0.4mg/ml will be applied to cottonoid pledgets and placed into the radial incisions for 3 minutes.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
57.1 Years of age
STANDARD_DEVIATION 12.4 • n=5 Participants
|
48 Years of age
STANDARD_DEVIATION 8.3 • n=7 Participants
|
53 Years of age
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age of Onset
|
52.2 Years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
44.2 Years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
49 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Etiology
Idiopathic
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Etiology
Granulomatosis with Polyangiitis
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Etiology
Post-Intubation
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Site
Subglottis
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Site
Trachea
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Site
Subglottis and Trachea
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Prior laryngotracheal stenosis surgery
Yes
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Prior laryngotracheal stenosis surgery
No
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Average prior laryngotracheal stenosis surgeries
|
1.1 Surgeries
STANDARD_DEVIATION 1.5 • n=5 Participants
|
4 Surgeries
STANDARD_DEVIATION 4.9 • n=7 Participants
|
2 Surgeries
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Prior treatment with Mitomycin C
Yes
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Prior treatment with Mitomycin C
No
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Prior treatment with Kenalog
Yes
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Prior treatment with Kenalog
No
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Patients who did not undergo a subsequent surgery after the initial study surgery were excluded as a surgical interval could not be calculated. There were two patients in each arm that did not have subsequent surgeries
Length of time between surgeries for laryngotracheal stenosis during the study
Outcome measures
| Measure |
Saline
n=7 Participants
Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of isotonic saline in the radial incisions.
Saline application: Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention.
|
Mitomycin-C
n=4 Participants
Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of MMC in the radial incisions.
Mitomycin -C: Topical mitomycin-C at a dosage of 0.4mg/ml will be applied to cottonoid pledgets and placed into the radial incisions for 3 minutes.
|
|---|---|---|
|
Time to Repeat Surgery
|
17.9 Months
Standard Deviation 15.7
|
17.4 Months
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Time to symptom score (CCQ) progression was calculated for each surgery performed during the study with available CCQ data.
Symptom improvement was measured using the Clinical COPD Questionnaire, a 10-point patient reported symptom score. Duration of symptom improvement was defined as the time from surgery to the time that symptoms to worsened beyond a CCQ score of 1 or the time to the subsequent surgery if CCQ never exceeded 1
Outcome measures
| Measure |
Saline
n=13 Surgeries
Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of isotonic saline in the radial incisions.
Saline application: Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention.
|
Mitomycin-C
n=6 Participants
Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of MMC in the radial incisions.
Mitomycin -C: Topical mitomycin-C at a dosage of 0.4mg/ml will be applied to cottonoid pledgets and placed into the radial incisions for 3 minutes.
|
|---|---|---|
|
Duration of Symptom Improvement
|
4.1 Months
Standard Deviation 6.7
|
6.0 Months
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Improvement in peak inspiratory flow (PIF) was calculated for each surgery performed during the study with available PIF data
Change in maximum inspiratory air flow from preoperative value to highest postoperative value within 3 months of surgery. Calculation details: Highest postoperative value within 3 months of surgery minus preoperative value.
Outcome measures
| Measure |
Saline
n=14 Surgeries
Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of isotonic saline in the radial incisions.
Saline application: Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention.
|
Mitomycin-C
n=8 Surgeries
Patients will undergo standard endoscopic surgical treatment for LTS involving CO2 laser radial incisions and balloon dilation, as well as topical application of MMC in the radial incisions.
Mitomycin -C: Topical mitomycin-C at a dosage of 0.4mg/ml will be applied to cottonoid pledgets and placed into the radial incisions for 3 minutes.
|
|---|---|---|
|
Peak Inspiratory Flow Measurement
|
1.1 Liters per second
Standard Deviation 1.5
|
1.3 Liters per second
Standard Deviation 0.96
|
Adverse Events
Mitomycin-C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place