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”

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

Study Type: Interventional

Study Design: Treatment, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

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

Primary Measures

• safety
  • Time Frame: end of study
    Safety Issue?: Yes

Secondary Measures

• Airway hyper-responsiveness
  • Time Frame: end of study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Inverseon, Inc.

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00670267

Study ID Number: SAND1002

ClinicalTrials.gov Identifier: NCT00670267

Health Authority: United States: Food and Drug Administration