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Oral Nadolol for the Treatment of Adults With Mild Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
nadolol
Sponsored by
Invion, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, hyperresponsiveness

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label treatment with oral Nadolol

Arm Description

Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.

Outcomes

Primary Outcome Measures

Mean Daily Dose at Study Termination Across Participants
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
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 Outcome Measures

Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)
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
Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline
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).

Full Information

First Posted
April 29, 2008
Last Updated
April 6, 2016
Sponsor
Invion, Inc.
Collaborators
University of Houston, Sandler Program for Asthma Research, Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00670267
Brief Title
Oral Nadolol for the Treatment of Adults With Mild Asthma
Official Title
An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Invion, Inc.
Collaborators
University of Houston, Sandler Program for Asthma Research, Baylor College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, hyperresponsiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label treatment with oral Nadolol
Arm Type
Experimental
Arm Description
Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.
Intervention Type
Drug
Intervention Name(s)
nadolol
Other Intervention Name(s)
Corgard
Intervention Description
Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
Primary Outcome Measure Information:
Title
Mean Daily Dose at Study Termination Across Participants
Description
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.
Time Frame
Baseline to end of study (105 days)
Title
Daily Dose at Study Termination Across Participants
Description
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.
Time Frame
Baseline to end of study (105 days)
Secondary Outcome Measure Information:
Title
Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)
Description
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).
Time Frame
Baseline to end of study (105 days)
Title
Percent Change in FEV1% Predicted From Baseline to End of Study
Time Frame
Baseline to end of study (105 days)
Title
Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline
Description
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).
Time Frame
Baseline to end of study (105 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola A Hanania, MD
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17703976
Citation
Hanania NA, Singh S, El-Wali R, Flashner M, Franklin AE, Garner WJ, Dickey BF, Parra S, Ruoss S, Shardonofsky F, O'Connor BJ, Page C, Bond RA. The safety and effects of the beta-blocker, nadolol, in mild asthma: an open-label pilot study. Pulm Pharmacol Ther. 2008;21(1):134-41. doi: 10.1016/j.pupt.2007.07.002. Epub 2007 Jul 17.
Results Reference
background
PubMed Identifier
19171883
Citation
Nguyen LP, Lin R, Parra S, Omoluabi O, Hanania NA, Tuvim MJ, Knoll BJ, Dickey BF, Bond RA. Beta2-adrenoceptor signaling is required for the development of an asthma phenotype in a murine model. Proc Natl Acad Sci U S A. 2009 Feb 17;106(7):2435-40. doi: 10.1073/pnas.0810902106. Epub 2009 Jan 26.
Results Reference
background
Links:
URL
http://erj.ersjournals.com/content/36/4/963.long
Description
ERS Publication: Response to salbutamol in patients with mild asthma treated with nadolol

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Oral Nadolol for the Treatment of Adults With Mild Asthma

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