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| Name | Class |
|---|---|
| University of Houston | OTHER |
| Sandler Program for Asthma Research | OTHER |
| Baylor College of Medicine | OTHER |
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The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nadolol | Drug | Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola A Hanania, MD | University of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17703976 | Background | 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. | |
| 19171883 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Treatment With Oral Nadolol | Dose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mg | Baseline to end of study (105 days) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label | nadolol: Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reduced pulmonary function | Reproductive system and breast disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| N.A. Hanania, M.D. | Baylor College of Medicine | hanania@bcm.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D009248 | Nadolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| 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 | 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). | Baseline to end of study (105 days) |
| 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. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 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. | Posted | Number | participants | Baseline to end of study (105 days) |
|
|
|
| Secondary | 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). | Analysis excludes one early termination subject | Posted | Mean | Standard Deviation | mg/mL | Baseline to end of study (105 days) |
|
|
|
| Secondary | Percent Change in FEV1% Predicted From Baseline to End of Study | Posted | Mean | Standard Deviation | percent change in FEV1% predicted | Baseline to end of study (105 days) |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline to end of study (105 days) |
|
|
|
| 0 |
| 10 |
| 1 |
| 10 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| Title | Measurements |
|---|
|
| 10.0mgs |
|
| 20mgs |
|
| 40mgs |
|