Trial Outcomes & Findings for Efficacy and Safety of Βeta-adrenoceptor Inverse Agonist and Biased Ligand, Nadolol, In Smoking Cessation of Patients With Chronic Cough With or Without Airflow Obstruction (NCT NCT01825122)
NCT ID: NCT01825122
Last Updated: 2017-02-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Baseline to end of treatment, up to 15 weeks
Results posted on
2017-02-01
Participant Flow
Participant milestones
| Measure |
Placebo
placebo
Placebo
|
Active, Nadolol
Active
Nadolol
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
78
|
|
Overall Study
COMPLETED
|
67
|
59
|
|
Overall Study
NOT COMPLETED
|
10
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Βeta-adrenoceptor Inverse Agonist and Biased Ligand, Nadolol, In Smoking Cessation of Patients With Chronic Cough With or Without Airflow Obstruction
Baseline characteristics by cohort
| Measure |
Placebo
n=77 Participants
placebo
Placebo
|
Active, Nadolol
n=78 Participants
Active
Nadolol
|
Total
n=155 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
|
|
Age, Categorical
Between 18 and 65 years
|
67 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Continuous
|
48.08 years
STANDARD_DEVIATION 13.58 • n=99 Participants
|
44.08 years
STANDARD_DEVIATION 12.52 • n=107 Participants
|
46.06 years
STANDARD_DEVIATION 13.17 • n=206 Participants
|
|
Gender
Female
|
45 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Gender
Male
|
32 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=99 Participants
|
78 participants
n=107 Participants
|
155 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of treatment, up to 15 weeksPopulation: The analysis population reflects all patients who achieved maintenance dosing, including those who did not complete the study
Outcome measures
| Measure |
Placebo
n=72 Participants
placebo
Placebo
|
Active, Nadolol
n=73 Participants
Active
Nadolol
|
|---|---|---|
|
Change From Baseline in the Average Number of Cigarettes Smoked Per Day
≥ 70% Reduction from Baseline
|
36 participants
|
45 participants
|
|
Change From Baseline in the Average Number of Cigarettes Smoked Per Day
< 70% reduction from baseline
|
36 participants
|
28 participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Active, Nadolol
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=77 participants at risk
placebo
Placebo
|
Active, Nadolol
n=78 participants at risk
Active
Nadolol
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/77 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
1.3%
1/78 • Number of events 1 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
|
Psychiatric disorders
Bipolar episode
|
0.00%
0/77 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
1.3%
1/78 • Number of events 1 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.3%
1/77 • Number of events 1 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
0.00%
0/78 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
Other adverse events
| Measure |
Placebo
n=77 participants at risk
placebo
Placebo
|
Active, Nadolol
n=78 participants at risk
Active
Nadolol
|
|---|---|---|
|
Cardiac disorders
Dizziness
|
6.5%
5/77 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
3.8%
3/78 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.2%
4/77 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
2.6%
2/78 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
3/77 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
9.0%
7/78 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
22.1%
17/77 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
26.9%
21/78 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
|
Gastrointestinal disorders
Dysgeusia
|
10.4%
8/77 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
7.7%
6/78 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/77 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
5.1%
4/78 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
|
Nervous system disorders
Headache
|
7.8%
6/77 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
3.8%
3/78 • Up to 30 days following discontinuation of the study, for up to 21 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60