The main purpose of this study is to evaluate the effect of NAL ER on 24-hour cough frequency and to assess safety and tolerability of NAL-ER for treatment of refractory chronic cough.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
McMaster University Medical Centre
Hamilton, Ontario, Canada
Inspiration Research
Toronto, Ontario, Canada
Relative Change From Baseline in 24-hour Cough Frequency at Day 21
Time frame: Baseline, Day 21
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 15
Relative Change From Baseline in 24-hour Cough Frequency at Days 7 and 14
Time frame: Baseline, Day 7 and 14
Percentage of Participants With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency at Days 7, 14, and 21
Time frame: At Days 7, 14, and 21
Relative Change From Baseline in Awake Cough Frequency at Days 7, 14, and 21
Time frame: Baseline, Day 7, 14 and 21
Relative Change From Baseline in Sleep Cough Frequency at Days 7, 14, and 21
Time frame: Baseline, Day 7, 14 and 21
Change From Baseline in Cough Severity Visual Analogue Scale at Days 7, 14, and 21
Time frame: Baseline, Day 7, 14 and 21
Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Day 21
Time frame: Baseline, Day 21
Change From Baseline in Patient-Reported Cough Frequency (PR-CF) at Days 7, 14, and 21
Time frame: Baseline, Day 7, 14 and 21
Percentage of PR-CF Responders With at Least one Category Improvement at Days 7, 14, and 21
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CIC Mauricie Inc.
Trois-Rivières, Quebec, Canada
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
Cottingham, East Riding Of Yorkshire, United Kingdom
Kings College Hospital NHS Foundation Trust
London, Greater London, United Kingdom
University Hospital of South Manchester NHS Foundation Trust (UHSM) - Wythenshawe Hospital
Manchester, Greater Manchester, United Kingdom
Accellacare South London
Orpington, Kent, United Kingdom
Accellacare North London
Northwood, Middlesex, United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
North Tyneside General Hospital - Northumbria Healthcare NHS Foundation Trust
North Shields, Tynemouth, United Kingdom
...and 4 more locations
Time frame: At Days 7, 14, and 21
Change From Baseline in Patient Global Impression of Severity (PGI-S) Cough at Days 7, 14, and 21
Time frame: Baseline, Day 7, 14 and 21
Absolute Values of Patient Global Impression of Change for Cough (PGI-C) Score at Days 7, 14, and 21
Time frame: At Days 7, 14, and 21
Change From Baseline in Clinicians Global Impression of Cough Severity Score at Day 21
Time frame: Baseline, Day 21
Absolute Values of Clinicians Global Impression of Change for Cough Score at Day 21
Time frame: At Day 21