Trial Outcomes & Findings for Oral Nadolol for the Treatment of Adults With Mild Asthma (NCT NCT00670267)
NCT ID: NCT00670267
Last Updated: 2016-05-11
Results Overview
The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out.
COMPLETED
PHASE1/PHASE2
10 participants
Baseline to end of study (105 days)
2016-05-11
Participant Flow
Participant milestones
| Measure |
Open Label Treatment With Oral Nadolol
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Nadolol for the Treatment of Adults With Mild Asthma
Baseline characteristics by cohort
| Measure |
Open Label
n=10 Participants
nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (105 days)The outcome measure describes the mean daily dose achieved by the subjects at study termination. This data includes one subject who terminated early, having reached 2.5mgs and subsequently reducing to 1.25mgs prior to dropping out.
Outcome measures
| Measure |
Open Label Treatment With Oral Nadolol
n=10 Participants
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
|
|---|---|
|
Mean Daily Dose at Study Termination Across Participants
|
29.6 mg
Standard Deviation 16.8
|
PRIMARY outcome
Timeframe: Baseline to end of study (105 days)The outcome measure describes the final daily dose achieved by the subjects in this study. The subjects described below who finished on less than the highest dose (i.e., 1.25, 5, and 10mgs) had all been down-titrated one dose (i.e., from 2.5, 10, and 20mgs) prior to completing the study on the dose reported.
Outcome measures
| Measure |
Open Label Treatment With Oral Nadolol
n=10 Participants
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
|
|---|---|
|
Daily Dose at Study Termination Across Participants
1.25mgs
|
1 participants
|
|
Daily Dose at Study Termination Across Participants
2.5mgs
|
0 participants
|
|
Daily Dose at Study Termination Across Participants
5.0mgs
|
1 participants
|
|
Daily Dose at Study Termination Across Participants
10.0mgs
|
1 participants
|
|
Daily Dose at Study Termination Across Participants
20mgs
|
0 participants
|
|
Daily Dose at Study Termination Across Participants
40mgs
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline to end of study (105 days)Population: Analysis excludes one early termination subject
Bronchoprovocation assessment was done by doubling doses of methacholine in accordance with the methodology recommended by the American Thoracic Society in the official policy statement adopted by the ATS Board of Directors, July 1999 (Guidelines for Methacholine and Exercise Challenge Testing-1999).
Outcome measures
| Measure |
Open Label Treatment With Oral Nadolol
n=9 Participants
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
|
|---|---|
|
Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)
|
1.8 mg/mL
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline to end of study (105 days)Outcome measures
| Measure |
Open Label Treatment With Oral Nadolol
n=10 Participants
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
|
|---|---|
|
Percent Change in FEV1% Predicted From Baseline to End of Study
|
-5.9 percent change in FEV1% predicted
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: Baseline to end of study (105 days)In the E.F. Juniper Asthma Control Questionnaire, a lower number reflects better control of asthma symptoms. A positive change in ACQ score reflects a reduction in control compared to baseline; conversely, a negative change in ACQ score reflects an increase in control compared to baseline. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
Outcome measures
| Measure |
Open Label Treatment With Oral Nadolol
n=10 Participants
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
|
|---|---|
|
Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline
|
0.3 units on a scale
Standard Deviation 0.7
|
Adverse Events
Open Label
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label
n=10 participants at risk
nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
|
|---|---|
|
Reproductive system and breast disorders
Reduced pulmonary function
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place