A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough

NCT03979638 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: BUS-P2-012019-000375-16
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 16

Brief Summary

This is a multi-center, randomized, double-blind, placebo-controlled, crossover, dose escalation study of BLU-5937 in subjects with unexplained or refractory chronic cough

Conditions

Chronic Refractory Cough

Keywords

Unexplained or refractory chronic cough, P2X3 antagonists

Outcome Measures

Primary Outcomes (1)

• Change in Awake Objective Cough Frequency on Log-transformed Scale

  Change in awake cough frequency (average hourly cough frequency while the subject is awake ) evaluated using the VitaloJAK cough monitor with 24-hour sound recordings collected

  Period 1: baseline (Day 0) and 24 hours after Day 4, 8, 12, 16 doses ; Period 2: baseline (Day 30) and 24 hours after Day 34, 38, 42, 46 doses

Other Outcomes (2)

• Change in Awake Cough Frequency on Log-transformed Scale in the Subgroup of Participants With Awake Cough Frequency > or = 20 Coughs/Hour at Baseline

  Period 1: baseline (Day 0) and 24 hours after Day 4, 8, 12, 16 doses ; Period 2: baseline (Day 30) and 24 hours after Day 34, 38, 42, 46 doses

• Change in Awake Cough Frequency on Log-transformed Scale in the Subgroup of Participants With Awake Cough Frequency > or = Median (32.4 Coughs/Hour) at Baseline

  Period 1: baseline (Day 0) and 24 hours after Day 4, 8, 12,16 doses ; Period 2: baseline (Day 30) and 24 hours after Day 34, 38, 42, 46 doses

Study Arms (2)

BLU-5937 oral tablet BID

EXPERIMENTAL

Randomized crossover design of 4 different doses (25, 50, 100, 200 mg BID) of BLU-5937 tablets to be administered orally BID

Drug: BLU-5937

Placebo oral tablet BID

PLACEBO COMPARATOR

Randomized crossover design of matching placebo tablets to be administered orally BID

Drug: Placebo

Interventions

BLU-5937 DRUG

Four escalating doses of BLU-5937 administered BID over the course of the study

BLU-5937 oral tablet BID

Placebo DRUG

Matching placebo for BLU-5937

Placebo oral tablet BID

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unexplained or refractory chronic cough for at least one year
• Chest radiograph or CT thorax within the last 60 months not demonstrating any abnormality considered to be significantly contributing to the chronic cough
• Cough count of ≥ 10 per hour (Awake Cough Count) at Screening
• Score of ≥ 40mm on the Cough Severity VAS at Screening
• Women of child-bearing potential must have a negative serum pregnancy test at Screening
• Women of child-bearing potential must use a highly effective contraception method from Screening through the Follow-Up Visit
• Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control

You may not qualify if:

• Current smoker or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history
• Diagnosis of COPD, bronchiectasis, idiopathic pulmonary fibrosis
• Treatment with an ACE-inhibitor as the potential cause of a subject's cough, or requiring treatment with an ACE-inhibitor during the study, or within 12 weeks prior to the Screening Visit
• FEV1/FVC \< 60%
• History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
• History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening
• History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years
• Clinically significant abnormal electrocardiogram (ECG) or laboratory tests at Screening
• Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results

Sponsors & Collaborators

• Bellus Health Inc. - a GSK company: lead

Study Sites (16)

Allergy Associates Medical Group Inc.

San Diego, California, 92108, United States

Location

Allergy & Asthma Associates of Santa Clara Valley

San Jose, California, 95117, United States

Location

Centre for Cough

Largo, Florida, 33778, United States

Location

Clinical Research Institute

Minneapolis, Minnesota, 55402, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 20854, United States

Location

National Allergy & Asthma Research

Charleston, South Carolina, 29420, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Allergy Asthma & Sinus Center

Greenfield, Wisconsin, 53228, United States

Location

Belfast City Hospital

Belfast, BT9 7BL, United Kingdom

Location

Castle Hill Hospital

Cottingham, HU16 5JQ, United Kingdom

Location

University Hospitals of Leicester

Leicester, LE3 9QP, United Kingdom

Location

Prince Phillip Hospital

Llanelli, SA14 8QF, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6HP, United Kingdom

Location

Manchester Clinical Research Facility

Manchester, M23 9LT, United Kingdom

Location

North Tyneside General Hospital

North Shields, NE29 8NH, United Kingdom

Location

MeSH Terms

Conditions

Chronic Cough

Interventions

BLU-5937

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Director Clinical Development
• Organization: Bellus Health Inc

lharvey@bellushealth.com

833-703-0708

Study Officials

• Jacky Smith, MD, Ph.D.

  University of Manchester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-arm, Two-Period, crossover assignment

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 7, 2019
• Study Start: July 10, 2019
• Primary Completion: April 23, 2020
• Study Completion: April 23, 2020
• Last Updated: August 3, 2021
• Results First Posted: August 3, 2021

Record last verified: 2020-04

Locations

US (8); GB (8)