Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00600028
• Date of registration: 11/01/2008
• Prospective Registration: No
• Primary sponsor: Johns Hopkins University
• Public title: Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide
• Scientific title: Treatment of Chronic Cough in Idiopathic Pulmonary Fibrosis With Thalidomide
• Date of first enrolment: December 2007
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00600028
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Maureen Horton, MD
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Idiopathic pulmonary fibrosis for >3 months <5 years

- High resolution CT scan of chest consistent with IPF within the previous 12 months

- FVC > 40% and < 90% predicted, TLC >40% <80%, DLCo >30% <90%

- Chronic Cough - cough >8 weeks

- Age >50

- Non-child bearing potential

Exclusion Criteria:

- Pregnant or lactating women

- Women of child bearing potential

- Known etiology of lung fibrosis other than IPF

- Significant respiratory toxin exposure

- Collagen Vascular Disease

- Use of narcotic anti-cough agent in last week

- significant peripheral vascular disease or neuropathy

- history of seizures

- poorly controlled diabetes

- allergy to thalidomide



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Cough

Intervention(s)

Drug: Placebo

Drug: Thalidomide

Primary Outcome(s)

Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Cough Quality of Life Questionnaire. [Time Frame: 6 months]

Secondary Outcome(s)

Efficacy of Thalidomide in Suppressing the Chronic Cough of Idiopathic Pulmonary Fibrosis Using the Visual Analog Scale of Cough and the St. George Respiratory Questionnaire. [Time Frame: 6 months]

Secondary ID(s)

CG-0747

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00600028