Mild Persistent Asthma, UncomplicatedPhase 2NCT01804218
Efficacy and Safety of Beta-adrenoceptor Inverse Agonist, Nadolol, in Mild Asthma
A Phase 2 study testing Nadolol in people with Mild Persistent Asthma, Uncomplicated, run by Invion, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to test the hypothesis that 18-22 week treatment with the inverse agonist nadolol will improve airway hyperresponsiveness in patients with mild asthma, compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mild Persistent Asthma, Uncomplicated
- What is being tested?
- Nadolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2013to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- 1. Males and females with physician-diagnosed asthma between the ages of 18- 60.
- 2. Pre-bronchodilator FEV1 80% or greater than the predicted value
- 3. Baseline PC20 (based on FEV1) ≤ 4 mg/ml on methacholine challenge test.
- 4. Asthma Control Questionnaire Score (ACQ) <1.25
- 5. Baseline blood pressure ≥ 110/65mm Hg
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- 6. Baseline pulse rate ≥ 60 beats/min.
- 7. Never-smoker or former-smoker < 10 pack.year and has not smoked within 1 year.
- 8. Able to complete diary cards and comply with study procedures.
- 9. Females of childbearing age may participate only if they have a negative pregnancy test, are non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
Who cannot join
- Subjects who meet ANY of the following criteria are not eligible for enrollment:
- Inability or unwillingness of the participant to give written informed consent
- History of upper/lower respiratory tract infection or asthma exacerbation requiring systemic steroids within 6 weeks of Visit 1
- Use of rescue medication (e.g., albuterol) more than twice per week during the week preceding Visit 1 excluding the use of such medication as preventative prior to exercise.
- History of hospitalization for asthma in the preceding year
- History of intubation for asthma
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- Currently diagnosed with chronic obstructive pulmonary disease (COPD)
- Currently taking any beta-blocker medication
- History of adverse reaction or allergy to any beta-blocker medication
- History of neurological, hepatic, renal, or other medical conditions that may interfere with the interpretation of data or the patient's participation in the study or may increase safety concerns
- Current diabetes or hyperthyroidism
- History of cardiovascular diseases including uncontrolled hypertension (BP >160/100), ischemic heart disease, congestive heart failure, valvular heart disease or cardiomyopathy
- Known allergy or sensitivity to atropine or ipratropium bromide
- Abnormal entry laboratory values at baseline except for the following tests, where values outside the normal limits will be acceptable as follows: Hct ≥ 30%, platelet count > 100,000, ALT and AST < 1.5 x upper normal limit
- Known bleeding disorders, platelet count <100,000, PT or PTT > 1.5 x normal control (if participating in bronchoscopy sub-study)
- Known allergy to lidocaine (if participating in bronchoscopy sub-study)
- Documented or self-reported current history of alcoholism or drug abuse
- Participation in another research trial within 30 days of starting this trial
- Unwillingness or inability to comply with study procedures
- Inability to swallow the study medication capsule
- Use of any exclusion medication within the time period specified
- Pregnant or nursing
- Receiving allergen immunotherapy (desensitization injections)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27704
Baylor College of Medicine
Houston, Texas, 77030
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The purpose of this study is to test the hypothesis that 18-22 week treatment with the inverse agonist nadolol will improve airway hyperresponsiveness in patients with mild asthma, compared to placebo.
- Conditions
- Mild Persistent Asthma, Uncomplicated
- Being tested
- Nadolol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NadololDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Active, nadolol | Experimental | Active Receives: Drug: Nadolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in methacholine provocative concentration causing a 20% fall (PC20) based on forced expiratory volume in 1 second (FEV1) between baseline visit and final dose dispensing visit.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Persistent Asthma, UncomplicatedStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Invion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola A. Hanania, MD, MS, Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804218
- Sponsor's protocol ID
- U01-BCM-01
- Status last verified
- Aug 2016
- First submitted
- 1 Mar 2013
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Beta-adrenoceptor Inverse Agonist, Nadolol, in Mild Asthma
- ClinicalTrials.gov ID
- NCT01804218
- Acronym / sponsor ID
- U01-BCM-01
- Conditions
- Mild Persistent Asthma, Uncomplicated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Invion, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2016 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
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 test the hypothesis that 18-22 week treatment with the inverse agonist nadolol will improve airway hyperresponsiveness in patients with mild asthma, compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Active, nadolol | Experimental | Drug: NadololActive |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Individuals who meet all of the following criteria are eligible for enrollment as study participants:
- 1. Males and females with physician-diagnosed asthma between the ages of 18- 60.
- 2. Pre-bronchodilator FEV1 80% or greater than the predicted value
- 3. Baseline PC20 (based on FEV1) ≤ 4 mg/ml on methacholine challenge test.
- 4. Asthma Control Questionnaire Score (ACQ) <1.25
Key exclusion criteria (23 listed)
- Inability or unwillingness of the participant to give written informed consent
- History of upper/lower respiratory tract infection or asthma exacerbation requiring systemic steroids within 6 weeks of Visit 1
- Use of rescue medication (e.g., albuterol) more than twice per week during the week preceding Visit 1 excluding the use of such medication as preventative prior to exercise.
- History of hospitalization for asthma in the preceding year
- History of intubation for asthma
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 |
|---|---|---|
| Nadolol | Drug | Active, nadolol |
| Placebo | Drug | Placebo |
Primary outcome
The change in methacholine provocative concentration causing a 20% fall (PC20) based on forced expiratory volume in 1 second (FEV1) between baseline visit and final dose dispensing visit.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
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, MS study chair
Baylor College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nadolol in people with Mild Persistent Asthma, Uncomplicated, run by Invion, Inc. at 3 sites 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 10 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Results are not available in the source record.
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?
The change in methacholine provocative concentration causing a 20% fall (PC20) based on forced expiratory volume in 1 second (FEV1) between baseline visit and final dose dispensing visit. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2016.