Oral Nadolol for the Treatment of Adults With Mild Asthma

An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00670267

Enrollment

Registered

2008-05-01

Start date

2007-01-31

Completion date

2009-06-30

Last updated

2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, hyperresponsiveness

Brief summary

The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.

Interventions

DRUGnadolol

Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Pre-bronchodilator FEV1 80% or greater than the predicted value. * PC20 FEV1 ≤4 mg/ml on methacholine challenge test. * Blood Pressure ≥ 100/65mm Hg. * Pulse rate ≥ 60 beats/min. * No significant health issues. * Non-smoker or X-smoker \< 10 pack/year.

Exclusion criteria

* History of upper/lower respiratory tract infection or asthma exacerbation within 6 weeks of first baseline visit. * Currently diagnosed with chronic obstructive pulmonary disease (COPD). * Used any oral or inhaled corticosteroids within 4 weeks of the first baseline visit.

Design outcomes

Primary

Measure	Time frame	Description
Mean Daily Dose at Study Termination Across Participants	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.
Daily Dose at Study Termination Across Participants	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.

Secondary

Measure	Time frame	Description
Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)	Baseline to end of study (105 days)	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).
Percent Change in FEV1% Predicted From Baseline to End of Study	Baseline to end of study (105 days)	—
Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline	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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Open Label nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.	10
Total	10

Baseline characteristics

Characteristic	Open Label
Age, Categorical <=18 years	1 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	9 Participants
Age, Continuous	32.6 years
Region of Enrollment United States	10 participants
Sex: Female, Male Female	8 Participants
Sex: Female, Male Male	2 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	1 / 10
serious Total, serious adverse events	0 / 10

Outcome results

Primary

Daily Dose at Study Termination Across Participants

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.