|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
9 January 2017 |
|
Main ID: |
NCT02009293 |
|
Date of registration:
|
01/12/2013 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis
Cough-IPF |
|
Scientific title:
|
Observational Study of the Effect of Pirfenidone on Cough in Patients With Idiopathic Pulmonary Fibrosis |
|
Date of first enrolment:
|
December 2013 |
|
Target sample size:
|
43 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02009293 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
|
Italy
|
Netherlands
| | | | | |
|
Contacts
|
|
Name:
|
C. Vancheri, Prof. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Catania, Italy |
|
|
Name:
|
V. Cottin, Prof. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Louis Pradel hospital, Lyon, France |
|
|
Name:
|
A Russell |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Royal Brompton & Harefield NHS Foundation Trust |
|
|
Name:
|
E Renzoni, Dr. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Royal Brompton & Harefield NHS Foundation Trust |
|
|
Name:
|
S Birring, Dr. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Respiratory Medicine,King's College Hospital.Denmark Hill, London |
|
|
Name:
|
M. S. Wijsenbeek, Dr. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Erasmus Medical Centre Rotterdam, The Netherlands |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Diagnosis of IPF according to American Thoracic Society (ATS) / European Respiratory
Society (ERS) criteria (5), definite and probable patients will be eligible
- Written informed consent
- Daily cough related to IPF (exclusion of other causes) present > 8 weeks
- cough score on visual analogue scale of = 40 mm.
- Carbon monoxide transfer capacity corrected for hemoglobin (TLCOc) = 30% and Forced
Vital Capacity (FVC) = 50%
- Pirfenidone therapy about to be initiated
- if a history positive for Gastro Esophageal Reflux (GER), using proton pump inhibitor
(PPI) > 4 weeks
Exclusion Criteria:
- Opiates, antitussive medication, antihistamines, steroids > equivalent of 10 mg
prednisone or N-acetylcysteine (NAC) within two weeks before study
- Change of steroid < 10 mg, inhalation steroids within 2 weeks of the study - History
of bronchial hyper responsiveness or asthma or relevant airway obstruction (FEV1/FVC
< 0.7)
- within 6 weeks of the start signs of respiratory tract infection, change of sputum
production and fever.
Age minimum:
40 Years
Age maximum:
85 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Idiopathic Pulmonary Fibrosis
|
|
Intervention(s)
|
|
Other: Cough monitor
|
|
Primary Outcome(s)
|
|
Change in cough frequency measured by cough recorder at week 12 compared to baseline
[Time Frame: 12 weeks]
|
|
Secondary Outcome(s)
|
|
Impact of cough on quality of life
[Time Frame: 12 weeks]
|
|
Change in cough frequency measured by cough recorder at 4 weeks compared to baseline
[Time Frame: 4 weeks]
|
|
Secondary ID(s)
|
|
NL44729.078.13
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|