Phase 2
Completed N=51
A Study of Gefapixant (AF-219/MK-7264) in Participants With Idiopathic Pulmonary Fibrosis (IPF) With Persistent Cough (MK-7264-016)
Source: ClinicalTrials.gov NCT02502097 ↗Enrolled (actual)
51
Serious AEs
7.3%
Results posted
May 2021
Primary outcomePrimary: Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined) — -9.1; -6.6; -6.6; -5.8 Coughs/hour — p=0.5096
Summary
A randomized, double-blind, placebo-controlled, crossover, dose escalation study of gefapixant (AF-219) in participants with Idiopathic Pulmonary Fibrosis (IPF) with persistent cough.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mixed Model of Repeated Measures (MMRM) Change From Baseline in Awake Objective Cough Frequency (Periods 1 & 2 Combined) |
-9.1; -6.6; -6.6; -5.8 | 0.5096 |
| PRIMARY Awake Objective Cough Frequency (Periods 1 & 2 Combined) |
46.2; 48.0; 37.1; 41.8; 39.4; 41.9 | — |
| PRIMARY Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined) |
-8.8; -6.6; -5.9; -5.7 | — |
| PRIMARY Percent Change From Baseline of Awake Objective Cough Frequency (Periods 1 & 2 Combined) |
-18.2; -14.1; -11.9; 6.6 | — |
| SECONDARY MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 1) |
-15.6; -11.9; -14.9; -13.1 | 0.5005 |
| SECONDARY MMRM Analysis of Change From Baseline in Awake Objective Cough Frequency (Period 2) |
-2.7; -1.3; 1.7; 1.5 | 0.8008 |
| SECONDARY Responder Analysis of Awake Cough Frequency at Day 7 (Periods 1 & 2 Combined) |
1; 1; 8; 5; 19; 11 | — |
| SECONDARY Responder Analysis of Awake Cough Frequency at Day 14 (Periods 1 & 2 Combined) |
3; 1; 11; 3; 18; 10 | — |
| SECONDARY MMRM Analysis of Change From Baseline 24-hour Objective Cough Frequency (Periods 1 & 2 Combined) |
-7.1; -4.7; -2.5; -4.0 | 0.3279 |
| SECONDARY MMRM Analysis of Change From Baseline in 24-hour Objective Cough Frequency (Period 1) |
-11.8; -8.5; -9.1; -10.1 | 0.3493 |
| SECONDARY MMRM Analysis of Change From Baseline in 24-hour Objective Cough Frequency (Period 2) |
-2.4; -0.9; 4.1; 2.1 | 0.6597 |
| SECONDARY 24-hour Objective Cough Frequency (Periods 1 & 2 Combined) |
33.6; 35.5; 26.4; 30.5; 30.6; 31.2 | — |
| SECONDARY Change From Baseline of 24-hour Cough Frequency (Periods 1 & 2 Combined) |
-6.8; -4.5; -2.0; -4.0 | — |
| SECONDARY Percent Change From Baseline of 24-hour Cough Frequency (Periods 1 & 2 Combined) |
-20.4; -14.6; -9.4; -9.7 | — |
| SECONDARY MMRM Analysis of Change From Baseline in Sleep Cough Frequency (Periods 1 & 2 Combined) |
-1.8; 0.8; 3.3; 0.6 | 0.1856 |
| SECONDARY MMRM Analysis of Change From Baseline in Cough Visual Analog Scale (VAS) (Periods 1 & 2 Combined) |
-16.3; -8.2; -14.3; -8.5 | 0.0847 |
| SECONDARY MMRM Analysis of Change From Baseline in Cough Quality of Life Questionnaire (CQLQ) (Periods 1 & 2 Combined) |
-2.3; -0.3; 0.2; 0.3 | 0.2290 |
| SECONDARY MMRM Analysis of Change From Baseline in Total Daily Cough Severity Diary (CSD) Score (Periods 1 & 2 Combined) |
-1.4; -0.4; -1.7; -0.7 | 0.0009 sig |
| SECONDARY MMRM Analysis of Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) (Periods 1 & 2 Combined) |
-3.9; -1.0; -2.4; 1.6 | 0.2938 |
| SECONDARY MMRM Analysis of Change From Baseline in Cough Borg CR10 Scale Score (Periods 1 & 2 Combined) |
-0.5; 0.1; -0.1; 0.3 | 0.2175 |
| SECONDARY Percentage of Participants With Borg CR10 Perception of Breathless Value ≥5 (Periods 1 & 2 Combined) |
41.67; 43.75; 50.00; 43.75 | — |
| SECONDARY Patient's Global Impression of Change (PGIC) Day 7 (Periods 1 & 2 Combined) |
3; 1; 14; 5; 12; 10 | — |
| SECONDARY Patient's Global Impression of Change (PGIC) Day 15 (Periods 1 & 2 Combined) |
5; 4; 16; 8; 8; 5 | — |
| SECONDARY Clinician's Global Impression of Change (CGIC) Day 15 (Periods 1 & 2 Combined) |
7; 3; 11; 4; 13; 6 | — |
| SECONDARY Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least Six Months |
2; 1; 4; 2; 5; 4 | — |
| SECONDARY Taste Acceptability Questionnaire: Number of Participants That Were Likely to Take Study Medication For At Least One Year |
3; 1; 3; 2; 5; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Idiopathic pulmonary fibrosis diagnosis based upon the American Thoracic Society (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) IPF 2011 guideline
- Life expectancy of greater than 6 months
- Stable medical condition (IPF) for at least 4 weeks
- Self-reported history of troublesome daily cough for more than 8 weeks
- Score of ≥ 40mm on the Cough Severity Visual Analogue Scale (VAS) at Screening
- Women of child-bearing potential must use 2 forms of acceptable birth control 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 from Screening until 3 months after the last dose of study drug
- Written informed consent
- Willing and able to comply with all aspects of the protocol
Exclusion Criteria
- Current smoker (i.e., within the last 30 days).
- Initiation of treatment with an ACE-inhibitor within 4 weeks prior to the Baseline Visit (Day 0) or during the study
- History of upper and/or lower respiratory tract infection within 4 weeks of the Baseline Visit (Day 0)
- History of opioid use for treatment of cough within 1 week of the Baseline Visit (Day 0)
- Requiring prohibited medications
- Body mass index (BMI) 160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
- QTc interval >450 milliseconds in males, >470 milliseconds in females
- Significantly abnormal laboratory tests at Screening
- Breastfeeding
- Treatment with an investigational drug or biologic within 30 days preceding the first dose of study medication or plans to take another investigational drug or biologic within 30 days of study completion
- Blood donation within 56 days or plasma donation within 7 days prior to dosing
- 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
Data sourced from ClinicalTrials.gov (NCT02502097). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.