Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough

Conditions

• Refractory Chronic Cough

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Duloxetine 30 MG — DRUG
  30mg orally for 4 weeks
• Duloxetine 60 MG — DRUG
  60mg orally for 4 weeks
• Amitriptyline 25 MG — DRUG
  25 mg orally for 4 weeks
• Amitriptyline 50 MG — DRUG
  50 mg orally for 4 weeks
• Placebo 30 MG — DRUG
  30mg tablet with no active study ingredient for 4 weeks
• Placebo 60 MG — DRUG
  60mg tablet with no active study ingredient for 4 weeks

Study Details

This research study is evaluating the effectiveness of escalating doses of Amitriptyline and Duloxetine in reducing cough frequency in patients with refractory chronic cough (RCC)

Key Dates

Start date

Nov 1, 2021

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Duloxetine and Placebo
  Subjects will receive 30mg of Duloxetine for blinded period 1 (first 4 week treatment period) and 30mg of Duloxetine plus 30mg Placebo for blinded period 2 (additional 4 week treatment period). After this, subjects will be unblinded and receive routine clinical care for follow up phase (up to 52 weeks).
• Experimental: Duloxetine dose escalation
  Subjects will receive 30mg of Duloxetine for blinded period 1 (first 4 week treatment period) and 60mg of Duloxetine for blinded period 2 (additional 4 weeks treatment period). After this, subjects will be unblinded and receive routine clinical care for follow up phase (up to 52 weeks).
• Experimental: Amitriptyline and Placebo
  Subjects will receive 25mg of Amitriptyline for blinded period 1 (first 4 week treatment period) and 25mg of Amitriptyline plus 30mg Placebo for blinded period 2 (additional 4 week treatment period). After this, subjects will be unblinded and receive routine clinical care for follow up phase (up to 52 weeks).
• Experimental: Amitriptyline dose escalation
  Subjects will receive 25mg of Amitriptyline for blinded period 1 (first 4 week treatment period) and 50mg of Amitriptyline for blinded period 2 (additional 4 weeks treatment period). After this, subjects will be unblinded and receive routine clinical care for follow up phase (up to 52 weeks).
• Placebo Comparator: Placebo
  Subjects will receive 30mg of Placebo for blinded period 1 (first 4 week treatment period) and 60mg of Placebo for blinded period 2 (additional 4 weeks treatment period). After this, subjects will be unblinded and receive routine clinical care for follow up phase (up to 52 weeks).

Primary Outcome Measure

Change in awake objective cough frequency (at 4 & 8 weeks) [ Time Frame: 4 weeks, 8 weeks ]

Locations (1)

Find similar trials in Rochester, MN

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