Additional identifiers
EudraCT number
2008-005045-34
ClinicalTrials.gov number
Protocol/serial number
PPCTP/001
Study information
Scientific title
A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin® in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin®
Acronym
PROMIS
Study hypothesis
Promixin® (colistimethate sodium) is currently approved for use in the management of patients with cystic fibrosis (CF) bronchiectasis who have pseudomonal lung infections, but not for use in patients with non-CF bronchiectasis who have pseudomonal lung infections. The infective agent is the same in both cases and it could be expected that Promixin® will provide benefit in patients with non-CF bronchiectasis as well as patients with CF bronchiectasis.
The purpose of this study is to determine if the use of inhaled colistimethate sodium (Promixin®) increases the time, compared to vehicle, from starting treatment with the investigational medicinal product (IMP) until the patients experience an infective pulmonary exacerbation, in patients with non-CF bronchiectasis infected with Pseudomonas aeruginosa (P. aeruginosa) susceptible to Promixin®. Treatment will be for up to 6 months and the safety profile of inhaled Promixin® therapy will be evaluated over this period.
On 28/09/2011 the following changes were made to the trial record:
1. The anticipated end date was changed from 26/08/2010 to 31/01/2012.
2. The Russian Federation and Ukraine have been added to the countires of recruitment.
3. The target number of participants was changed from 260 to 144; recruitment is now complete.
Ethics approval
Submitted to London Research Ethics Committee Northwick Park Hospital for the meeting on 29/10/2008 (ref: 08/H0718/71)
Study design
Multi-centre double-blind parallel-group vehicle-controlled randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Non-cystic fibrosis bronchiectasis; patients with proven Pseudomonas aeruginosa pulmonary infections
Intervention
Investigational medicinal product:
Inhaled Promixin® (colistimethate sodium) at a concentration of 1 million international units per mL (300 µL dose via an I-neb™ system) administered twice a day for up to 6 months.
Control:
Vehicle, 0.45% saline(300 µL dose via an I-neb™ system) administered twice a day for up to 6 months.
Joint/scientific contact details:
Diana Bilton MD FRCP
Consultant Physician/Honorary Senior Lecturer
Department of Respiratory Medicine
Royal Brompton Hospital
Sydney Street
London SW3 6NP
United Kingdom
Intervention type
Drug
Phase
Not Applicable
Drug names
Promixin® (colistimethate sodium)
Primary outcome measures
The time (in days) from baseline/visit 2 (first dose) for each individual patient, until he/she experiences an exacerbation.
Secondary outcome measures
1. Number of adverse events and serious adverse events, measured at end of the patients' involvement in the study
2. Changes in sputum mass from baseline to week 4
3. Changes in sputum flora, measured over the course of the study, samples collected at weeks 4, 12 and at the end of the patients' involvement in the study
4. Improvement in quality of life as assessed by Saint George's Respiratory Questionnaire (SGRQ) and compliance with treatment, measured at week 12 and at the end of the patients' involvement in the study
5. Changes in forced expiratory volume in one second (FEV1), measured at the end of the patients' involvement in the study and at the first dose
Overall trial start date
26/01/2009
Overall trial end date
31/01/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients of either gender, over 18 years of age
2. Non-CF bronchiectasis
3. Are known to have grown P. aeruginosa from their sputum at least twice in the previous 12 months
4. Have experienced and completed treatment for an exacerbation of bronchiectasis within 21 days of screening
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
144
Participant exclusion criteria
1. CF bronchiectasis
2. Confirmed recent allergic bronchopulmonary aspergillosis
3. Immune suppression, hypogammaglobulinaemia, inflammatory bowel disease, primary ciliary dyskinesia or myloproliferative disease
4. Bronchoreactivity
5. Have used colistimethate sodium in the past, or are taking hypertonic saline, high doses of steroid or anti-tumour necrotising factor alpha (anti-TNFa)
6. Have recently started azithromycin
7. Female patients who are pregnant or nursing
Recruitment start date
26/01/2009
Recruitment end date
31/01/2012
Locations
Countries of recruitment
Russian Federation, Ukraine, United Kingdom
Trial participating centre
Consultant in Respiratory Medicine
Cambridge
CB23 3RE
United Kingdom
Sponsor information
Organisation
Profile Pharma Ltd (UK)
Sponsor details
Bicentennial Building
Southern Gate
Chichester
PO19 8EZ
United Kingdom
+44 (0) 1243 859000
info.profilepharma@zambongroup.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Profile Pharma Ltd (UK) (ref: PPCTP/001)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24625200
Publication citations
-
Results
Haworth CS, Foweraker JE, Wilkinson P, Kenyon RF, Bilton D, Inhaled colistin in patients with bronchiectasis and chronic Pseudomonas aeruginosa infection., Am. J. Respir. Crit. Care Med., 2014, 189, 8, 975-982, doi: 10.1164/rccm.201312-2208OC.