Chronic CoughPhase 2NCT03622216
A Dose Escalation Study of Bradanicline in Refractory Chronic Cough
A Phase 2 study testing Bradanicline in people with Chronic Cough, run by Attenua, Inc. at 17 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Cough
- What is being tested?
- Bradanicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 17 sitesUnited States
- Study dates
- 5 Nov 2018to 22 May 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chest radiograph or computed tomography (CT) scan of the thorax within the last 1 year not demonstrating any abnormality considered to be significantly contributing to the refractory chronic cough
- Diagnosis of refractory chronic cough or unexplained cough for at least one year
- Women of child-bearing potential who use 2 forms of acceptable birth control method
- Male subjects and their partners of child-bearing potential who use 2 methods of acceptable birth control
- Has provided written informed consent
Who cannot join
- Current smoker (cigarettes or e-cigarettes) or has given up smoking within the past 12 months
- Currently taking an ACE-inhibitor or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit
- Has an upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
- Has a history of cystic fibrosis
- Has a history of malignancy within 5 years prior to the Baseline Visit
- Has active hepatitis infection
Show all 9Show fewer
- Has a history of human immunodeficiency virus (HIV) infection
- Has a positive test for any drug of abuse
- Has a history of hypersensitivity to bradanicline or any of its components
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Bellingham Asthma Allergy and Immunology Clinic
Bellingham, Washington, 98225
Asthma and Allergy Associates
Colorado Springs, Colorado, 80907
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907
AARA Research Center
Dallas, Texas, 75231
Pharmaceutical Research and Consulting, Inc.
Dallas, Texas, 75231
Colorado Allergy and Asthma Center
Denver, Colorado, 80230
Clinical Research of Gastonia
Gastonia, North Carolina, 20854
Allery Asthma & Sinus Center
Greenfield, Wisconsin, 53228
BioSolutions Clinical Research Center
La Mesa, California, 91942
Center for Cough
Largo, Florida, 33872
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691
National Allergy and Asthma Research
North Charleston, South Carolina, 29420
Atlantic Research Center, LLC
Ocean Township, New Jersey, 07712
Clinical Research Institute
Plymouth, Minnesota, 55441
Mayo Clinic, Pulmonary Clinic Research Unit
Rochester, Minnesota, 55905
Diagnostics Research Group
San Antonio, Texas, 78229
Florida Pulmonary Research Institute
Winter Park, Florida, 32789
About this study
Official title: A Dose Escalation Study to Assess the Efficacy and Safety of Bradanicline in Subjects With Refractory Chronic Cough
This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough
Read the detailed description
This study will have two 21-day treatment periods separated by a 14-day washout period. There will be a 14-day follow-up period.
- Conditions
- Chronic Cough
- Being tested
- Bradanicline, Placebo
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BradaniclineDrug
Three different doses over the course of the study
PlaceboDrug
Matching placebo for Bradanicline
| Study group | Role | What they receive |
|---|---|---|
| Bradanicline QD | Experimental | Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD Receives: Drug: Bradanicline; Drug: Placebo |
| Placebo | Placebo comparator | Randomized crossover design of matching placebo tablets to be administered orally QD Receives: Drug: Bradanicline; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awake coughs per hour at Days 7, 14, 21, 43, 50, 57
Assessment of awake coughs per hour (average hourly cough frequency while the participant is awake based on sound recordings), to be evaluated using a digital recording device
Measured: Change from Baseline at Days 7, 14, 21, 43, 50, 57
Secondary outcomes (2)
24-hour coughs per hour at Days 7, 14, 21, 43, 50, 57
Assessment of 24-hour coughs per hour (average hourly cough frequency based on 24-hour sound recordings), to be evaluated using a digital recording device
Measured: Change from Baseline at Days 7, 14, 21, 43, 50, 57
Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up
Assessment of participants who have at least one AE during treatment period 1 (21 days), during washout (14 days), during treatment period 2 (21 days), and follow-up (14 days)
Measured: up to 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start5 Nov 2018
- Primary completion7 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoughStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attenua, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Attenua, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622216
- Sponsor's protocol ID
- ATA101-PN-001
- Status last verified
- Jun 2019
- First submitted
- 2 Aug 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Study to Assess the Efficacy and Safety of Bradanicline in Subjects With Refractory Chronic Cough
- ClinicalTrials.gov ID
- NCT03622216
- Acronym / sponsor ID
- ATA101-PN-001
- Conditions
- Chronic Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Attenua, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 9 Aug 2018 (actual)
- 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.
This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough
Detailed description
This study will have two 21-day treatment periods separated by a 14-day washout period. There will be a 14-day follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bradanicline QD | Experimental | Drug: Bradanicline, Drug: PlaceboRandomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD |
| Placebo | Placebo comparator | Drug: Bradanicline, Drug: PlaceboRandomized crossover design of matching placebo tablets to be administered orally QD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chest radiograph or computed tomography (CT) scan of the thorax within the last 1 year not demonstrating any abnormality considered to be significantly contributing to the refractory chronic cough
- Diagnosis of refractory chronic cough or unexplained cough for at least one year
- Women of child-bearing potential who use 2 forms of acceptable birth control method
- Male subjects and their partners of child-bearing potential who use 2 methods of acceptable birth control
- Has provided written informed consent
Key exclusion criteria (9 listed)
- Current smoker (cigarettes or e-cigarettes) or has given up smoking within the past 12 months
- Currently taking an ACE-inhibitor or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit
- Has an upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
- Has a history of cystic fibrosis
- Has a history of malignancy within 5 years prior to the 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 |
|---|---|---|
| BradaniclineThree different doses over the course of the study | Drug | Bradanicline QD, Placebo |
| PlaceboMatching placebo for Bradanicline | Drug | Bradanicline QD, Placebo |
Primary outcome
Awake coughs per hour at Days 7, 14, 21, 43, 50, 57
Time frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57
Assessment of awake coughs per hour (average hourly cough frequency while the participant is awake based on sound recordings), to be evaluated using a digital recording device
2 secondary outcomes
24-hour coughs per hour at Days 7, 14, 21, 43, 50, 57
Time frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57
Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up
Time frame: up to 57 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
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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.
Medical Director study director
Attenua, Inc.
17 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 Bradanicline in people with Chronic Cough, run by Attenua, Inc. at 17 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 5 inclusion and 9 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 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Awake coughs per hour at Days 7, 14, 21, 43, 50, 57 (time frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57). 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 20 Jun 2019.