Trial Outcomes & Findings for Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough (NCT NCT04429516)
NCT ID: NCT04429516
Last Updated: 2026-05-07
Results Overview
COMPLETED
PHASE3
44 participants
from baseline as assessed by objective digital cough monitoring at Day 14 of treatment
2026-05-07
Participant Flow
47 individuals assessed for eligibility 3 excluded 44 enrolled and randomly assigned
out if the 47 individuals assessed for eligibility 3 did not meet the inclusion criteria; 44 enrolled and randomly assigned and 1 withdrew before treatment
Participant milestones
| Measure |
Morphine Sulfate Then Placebo
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
Placebo Then Morphine Sulfate
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
Patients will then crossover after a 7 day wash out period.
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days.
|
|---|---|---|
|
Period 1 - Randomisation
STARTED
|
21
|
22
|
|
Period 1 - Randomisation
COMPLETED
|
21
|
22
|
|
Period 1 - Randomisation
NOT COMPLETED
|
0
|
0
|
|
Period 2 - CROSS-OVER
STARTED
|
21
|
22
|
|
Period 2 - CROSS-OVER
COMPLETED
|
17
|
20
|
|
Period 2 - CROSS-OVER
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Morphine Sulfate/Placebo for the Treatment of PulmonAry Fibrosis Cough
Baseline characteristics by cohort
| Measure |
Morphine Sulfate Then Placebo
n=21 Participants
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
Placebo Then Morphine Sulfate
n=22 Participants
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily. Patients will then crossover after a 7 day wash out period.
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Indian
|
2 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
|
Age, Customized
Age (years)
|
71 years
STANDARD_DEVIATION 7.2 • n=54 Participants
|
71 years
STANDARD_DEVIATION 7.5 • n=60 Participants
|
71 years
STANDARD_DEVIATION 7.4 • n=114 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=54 Participants
|
16 Participants
n=60 Participants
|
31 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
19 Participants
n=54 Participants
|
21 Participants
n=60 Participants
|
40 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: from baseline as assessed by objective digital cough monitoring at Day 14 of treatmentOutcome measures
| Measure |
Morphine Sulfate
n=43 Participants
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=39 Participants
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
|---|---|---|
|
The Percent Change in Daytime Cough Frequency (Coughs Per Hour)
|
-40.8 % change
Interval -54.2 to -23.6
|
-4.3 % change
Interval -21.8 to 17.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 14Population: Intention to treat
Living with Idiopathic Pulmonary Fibrosis (L-IPF): Developing a Patient-Reported Symptom and Impact Questionnaire to Assess Health-Related Quality of Life in IPF; on a scale between 0 to 4, where 0 is Not at all and 4 is Extremlly. QoL scores were measured at baseline and day 14. A single estimate was reported which is the mean change from baseline
Outcome measures
| Measure |
Morphine Sulfate
n=43 Participants
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=39 Participants
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
|---|---|---|
|
Change From Baseline in Health-related Quality of Life Scores (Living With Idiopathic Pulmonary Fibrosis Questionnaire)
|
-5.2 score on a scale
Interval -9.9 to -0.4
|
-1.7 score on a scale
Interval -5.5 to 2.1
|
SECONDARY outcome
Timeframe: At Day 0, Day 14Population: intention to treat
HADS - Hospital Anxiety and Depression Scale (Scoring 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case). QoL scores were measured at baseline and day 14. A single estimate was reported which is the mean change from baseline
Outcome measures
| Measure |
Morphine Sulfate
n=43 Participants
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=39 Participants
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
|---|---|---|
|
Change From Baseline in Health-related Quality of Life Scores (HADS- Hospital Anxiety and Depression Scale)
Anxiety
|
0.1 score on a scale
Interval -0.1 to 0.2
|
0.0 score on a scale
Interval -0.1 to 0.2
|
|
Change From Baseline in Health-related Quality of Life Scores (HADS- Hospital Anxiety and Depression Scale)
Depression
|
0.0 score on a scale
Interval 0.0 to 0.0
|
-0.1 score on a scale
Interval -0.2 to 0.1
|
SECONDARY outcome
Timeframe: At Day 0, Day 14Population: intention to treat
The KBILD is a self-completed health status questionnaire that comprises 15 items and a seven-point Likert response scale. It has three domains: psychological, breathlessness and activities and chest symptoms. The KBILD score ranges are 0-100; 100 represents best health status. QoL scores were measured at baseline and day 14. A single estimate was reported which is the mean change from baseline
Outcome measures
| Measure |
Morphine Sulfate
n=43 Participants
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=39 Participants
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
|---|---|---|
|
Change From Baseline in Health-related Quality of Life Scores (K-BILD - King's Brief Interstitial Lung Disease Questionnaire)
|
-0.2 score on a scale
Interval -0.6 to 0.2
|
0.2 score on a scale
Interval -0.5 to 0.9
|
SECONDARY outcome
Timeframe: At Day 0, Day 14Population: intention to treat
The Leicester Cough Questionnaire comprises of 19 questions. Score ranges from 3 to 21 with higher values indicating a better QoL. 8 of the questions assess the physical cough domain, 7 items assess the psychological impact of cough, and 4 questions assess the social impact of cough. QoL scores were measured at baseline and day 14. A single estimate was reported which is the mean change from baseline
Outcome measures
| Measure |
Morphine Sulfate
n=43 Participants
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=39 Participants
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
|---|---|---|
|
Change From Baseline in Self-reported Cough (Leicester Cough Questionnaire (LCQ)
|
1.8 score on a scale
Interval 0.9 to 2.8
|
0.6 score on a scale
Interval -0.2 to 1.3
|
SECONDARY outcome
Timeframe: At Day 0, Day 14Population: intention to treat
VAS - The cough visual analogue scale (VAS) represents a simple instrument, using a 100 mm linear scale where patient can indicate the severity of their cough between the two extremes: zero is no cough while 100 mm is the worst cough imaginable. QoL scores were measured at baseline and day 14. A single estimate was reported which is the mean change from baseline
Outcome measures
| Measure |
Morphine Sulfate
n=43 Participants
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=39 Participants
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
|---|---|---|
|
Change From Baseline in Self-reported Cough - Visual Analogue Scale (VAS)
|
-16.1 score on a scale
Interval -22.3 to -9.9
|
-0.4 score on a scale
Interval -5.8 to 4.9
|
SECONDARY outcome
Timeframe: At Day 0, Day 14Population: intention to treat
D-12 consists of 12 descriptor items on a scale of none (0), mild (1), moderate (2), or severe (3). It provides an overall score for breathlessness severity that incorporates seven physical items and five affective items. The range of scores is between 0 and 36 with higher score representing greater levels of dyspnoea. QoL scores were measured at baseline and day 14. A single estimate was reported which is the mean change from baseline
Outcome measures
| Measure |
Morphine Sulfate
n=43 Participants
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=39 Participants
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
|---|---|---|
|
Change From Baseline in Dyspnoea (Dyspnoea 12)
|
-0.1 score on a scale
Interval -1.9 to 1.6
|
0.9 score on a scale
Interval -0.5 to 2.2
|
SECONDARY outcome
Timeframe: At Day 14 and Day 36Population: intention to treat
It provides a brief, stand-alone assessment of treatment effect on cough, breathlessness and overall quality of live on a scale of: worse, same and better.
Outcome measures
| Measure |
Morphine Sulfate
n=43 Participants
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=41 Participants
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
|---|---|---|
|
Change From Baseline in Global Impression of Change in Quality of Life, Cough and Breathlessness.
Cough worse
|
8 participants
|
15 participants
|
|
Change From Baseline in Global Impression of Change in Quality of Life, Cough and Breathlessness.
Dyspnoea worse
|
6 participants
|
9 participants
|
|
Change From Baseline in Global Impression of Change in Quality of Life, Cough and Breathlessness.
Overall quality of life worse
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Comparison made between pre-treatment and at follow up visit in both the first and then the crossover arms of the study: Day 0, Day 14, Day 22 and Day 36Population: intention to treat
Proportion of responders with a minimum of 20% decrease from baseline at the end of treatment in 24-hour average cough count.
Outcome measures
| Measure |
Morphine Sulfate
n=43 Participants
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=39 Participants
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
|
|---|---|---|
|
Proportion of Responders With a Minimum of 20% Decrease From Baseline at the End of Treatment in 24-hour Average Cough Count.
|
25 participants
|
14 participants
|
Adverse Events
Morphine Sulfate
Placebo
Serious adverse events
| Measure |
Morphine Sulfate
n=43 participants at risk
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=42 participants at risk
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily. Patients will then crossover after a 7 day wash out period
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/43 • From baseline until event resolution, an average of 30 days
AEs were summarised for Morphine and Placebo arm separately. 43 people received Morphine and 42 received Placebo
|
2.4%
1/42 • Number of events 1 • From baseline until event resolution, an average of 30 days
AEs were summarised for Morphine and Placebo arm separately. 43 people received Morphine and 42 received Placebo
|
Other adverse events
| Measure |
Morphine Sulfate
n=43 participants at risk
Morphine Sulfate: over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
|
Placebo
n=42 participants at risk
Placebo oral tablet: capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily. Patients will then crossover after a 7 day wash out period
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
39.5%
17/43 • Number of events 17 • From baseline until event resolution, an average of 30 days
AEs were summarised for Morphine and Placebo arm separately. 43 people received Morphine and 42 received Placebo
|
14.3%
6/42 • Number of events 6 • From baseline until event resolution, an average of 30 days
AEs were summarised for Morphine and Placebo arm separately. 43 people received Morphine and 42 received Placebo
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place