Oral Nadolol for the Treatment of Adults With Mild Asthma - Tabular View

Tracking Information
First Received Date ^ICMJE	April 29, 2008
Last Updated Date	May 5, 2008
Start Date ^ICMJE	January 2007
Estimated Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 29, 2008)	safety [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00670267 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 29, 2008)	Airway hyper-responsiveness [ Time Frame: end of study ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Oral Nadolol for the Treatment of Adults With Mild Asthma
Official Title ^ICMJE	An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma
Brief Summary	The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Asthma
Intervention ^ICMJE	Drug: nadolol
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	10
Estimated Completion Date	December 2008
Estimated Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00670267
Responsible Party	Professor Nick Hanania, M.D., The Baylor College of Medicine
Study ID Numbers ^ICMJE	SAND1002
Study Sponsor ^ICMJE	Inverseon, Inc.
Collaborators ^ICMJE	University of Houston Sandler Program for Asthma Research Baylor College of Medicine
Investigators ^ICMJE
Information Provided By	Inverseon, Inc.
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP