Oral Nadolol for the Treatment of Adults With Mild Asthma

NCT00670267 | Completed Phase 1 Results

• 1 other identifier: SAND1002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma; hyperresponsiveness

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to end of study (105 days)

• 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.

  Baseline to end of study (105 days)

Secondary Outcomes (3)

• Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)

  Baseline to end of study (105 days)

• 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)

Study Arms (1)

Open Label treatment with oral Nadolol

EXPERIMENTAL

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

Drug: nadolol

Interventions

nadolol DRUG

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

Also known as: Corgard

Open Label treatment with oral Nadolol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Invion, Inc.: lead
• University of Houston: collaborator
• Sandler Program for Asthma Research: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 17703976 BACKGROUND

• 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.

  PMID: 19171883 BACKGROUND

Related Links

• ERS Publication: Response to salbutamol in patients with mild asthma treated with nadolol

MeSH Terms

Conditions

Asthma

Interventions

Nadolol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: N.A. Hanania, M.D.
• Organization: Baylor College of Medicine

hanania@bcm.edu

Study Officials

• Nicola A Hanania, MD

  University of Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 11, 2016
• Results First Posted: May 11, 2016

Record last verified: 2016-04

Locations

US (1)