Condition category
Respiratory
Date applied
20/10/2008
Date assigned
31/10/2008
Last edited
09/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charles Haworth

ORCID ID

Contact details

Consultant in Respiratory Medicine
Papworth Hospital
Cambridge
CB23 3RE
United Kingdom

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

http://www.profilepharma.com/

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

  1. 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.

Additional files

Editorial Notes