AsthmaPhase 1/2NCT00670267

Oral Nadolol for the Treatment of Adults With Mild Asthma

A Phase 1/2 study testing nadolol in people with Asthma, run by Invion, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Asthma
What is being tested?: nadolol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Jun 2009
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Baylor College of Medicine
Houston, Texas, 77030

Other trials in United States

About this study

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.

Conditions: Asthma
Being tested: nadolol
Keywords: Asthma, hyperresponsiveness
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00670267
Study group	Role	What they receive
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. Receives: Drug: nadolol

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
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).
Measured: Baseline to end of study (105 days)
Percent Change in FEV1% Predicted From Baseline to End of Study
Measured: 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).
Measured: Baseline to end of study (105 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Jun 2009

First posted1 May 2008 (estimated)
Study startJan 2007
Primary completionMay 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00670267
Sponsor's protocol ID: SAND1002
Status last verified: Apr 2016
First submitted: 29 Apr 2008
Last updated: 11 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 17703976
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.
PubMed 19171883

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00670267
Acronym / sponsor ID: SAND1002
Conditions: Asthma
Keywords: Asthma, hyperresponsiveness
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Invion, Inc.Industry (pharma, biotech, devices)
Collaborators: University of Houston, Sandler Program for Asthma Research, Baylor College of Medicine
Study start: Jan 2007
Primary completion: May 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 1 May 2008 (estimated)
Results: Posted 11 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open Label treatment with oral Nadolol	Experimental	Drug: nadololDose escalation through 1.25mgs, 2.5mgs, 5.0mgs, 10mgs, 20mgs, and 40mgs of nadolol at 2 week intervals as tolerated.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
nadololAlso: CorgardNadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.	Drug	Open Label treatment with oral Nadolol

Primary outcome

Mean Daily Dose at Study Termination Across Participants
Time frame: Baseline to end of study (105 days)
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
Time frame: Baseline to end of study (105 days)
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.

3 secondary outcomes

Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)
Time frame: Baseline to end of study (105 days)
Percent Change in FEV1% Predicted From Baseline to End of Study
Time frame: Baseline to end of study (105 days)
Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline
Time frame: Baseline to end of study (105 days)

Results and safety

Results posted to the registry on 11 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label Treatment With Oral Nadolol	10	9

Primary outcome: Mean Daily Dose at Study Termination Across Participants

Time frame: Baseline to end of study (105 days). Mean (Standard Deviation). Unit: mg

Measure	Open Label Treatment With Oral Nadolol n = 10
Value	29.6 (16.8)

Primary outcome: Daily Dose at Study Termination Across Participants

Time frame: Baseline to end of study (105 days). Number. Unit: participants

Measure	Open Label Treatment With Oral Nadolol n = 10
1.25mgs	1
2.5mgs	0
5.0mgs	1
10.0mgs	1
20mgs	0
40mgs	7

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label	0 of 10 (0%)	1 of 10 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17703976Hanania 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.
Background: PubMed 19171883Nguyen 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.
ERS Publication: Response to salbutamol in patients with mild asthma treated with nadololLink provided by the sponsor.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
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RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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RecruitingPhase 3
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicola A Hanania, MD principal investigator

University of Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing nadolol in people with Asthma, run by Invion, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Daily Dose at Study Termination Across Participants (time frame: Baseline to end of study (105 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00670267, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.