Trial Outcomes & Findings for Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis (NCT NCT02416102)
NCT ID: NCT02416102
Last Updated: 2020-08-20
Results Overview
NPD were assessed from nasal cells collected using sterile cytology brushes.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
Baseline, 8 weeks
Results posted on
2020-08-20
Participant Flow
Participant milestones
| Measure |
Healthy Non-smokers
10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg once daily (QD) for 4 weeks
losartan 100 mg: 50 mg twice daily (BID) for 4 weeks
|
Smokers Without COPD
10 smokers without Chronic Obstructive Pulmonary Disease (COPD) will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
Ex-smokers With COPD
10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
0
|
|
Overall Study
COMPLETED
|
7
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis
Baseline characteristics by cohort
| Measure |
Healthy Non-smokers
n=16 Participants
10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
Smokers Without COPD
n=15 Participants
10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
Ex-smokers With COPD
10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: Nasal sample data for all participants were not available as the readings were uninterpretable and not further analyzed.
NPD were assessed from nasal cells collected using sterile cytology brushes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: No participants were recruited in the Ex-Smokers with COPD due to difficulty in recruitment prior to study termination. Only 5 participants were analyzed for the Healthy Non-Smokers and Smokers without COPD arms as only 5 in each group had complete sets of samples that could be analyzed due to bad quality/quantity available.
Interleukin (IL)-8 concentrations were analyzed from samples on nasal lavage
Outcome measures
| Measure |
Healthy Non-smokers
n=5 Participants
10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
Smokers Without COPD
n=5 Participants
10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
Ex-smokers With COPD
10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
|---|---|---|---|
|
Change in IL-8 Concentrations
|
2867 pg/mL
Standard Deviation 1685
|
4676 pg/mL
Standard Deviation 1948
|
—
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: No participants were recruited in the Ex-Smokers with COPD due to difficulty in recruitment prior to study termination. Only 5 participants were analyzed for the Healthy Non-Smokers and Smokers without COPD arms as only 5 in each group had complete sets of samples that could be analyzed due to bad quality/quantity available.
Transforming Growth Factor (TGF)-ß messenger ribonucleic acid (mRNA) expression were analyzed from nasal cells samples.
Outcome measures
| Measure |
Healthy Non-smokers
n=5 Participants
10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
Smokers Without COPD
n=5 Participants
10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
Ex-smokers With COPD
10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks
Losartan 50 mg: 50 mg QD for 4 weeks
losartan 100 mg: 50 mg BID for 4 weeks
|
|---|---|---|---|
|
Percent Change in TGF-ß mRNA Expression
|
-51 percentage change in mRNA expression
Standard Deviation 31
|
-23 percentage change in mRNA expression
Standard Deviation 70
|
—
|
Adverse Events
Healthy Non-smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Smokers Without COPD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ex-smokers With COPD
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