Inhaled Promixin® in the treatment of non-cystic fibrosis bronchiectasis

ISRCTN	ISRCTN49790596
DOI	https://doi.org/10.1186/ISRCTN49790596
EudraCT/CTIS number	2008-005045-34
Secondary identifying numbers	PPCTP/001

Submission date: 20/10/2008
Registration date: 31/10/2008
Last edited: 09/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Charles Haworth
Scientific

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

Study information

Study design	Multi-centre double-blind parallel-group vehicle-controlled randomised study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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®
Study acronym	PROMIS
Study objectives	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(s)	Submitted to London Research Ethics Committee Northwick Park Hospital for the meeting on 29/10/2008 (ref: 08/H0718/71)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Promixin® (colistimethate sodium)
Primary outcome measure	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 study start date	26/01/2009
Completion date	31/01/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	144
Key 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
Key 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
Date of first enrolment	26/01/2009
Date of final enrolment	31/01/2012

Locations

Countries of recruitment

England
Russian Federation
Ukraine
United Kingdom

Study participating centre

Consultant in Respiratory Medicine

Cambridge
CB23 3RE
United Kingdom

Sponsor information

Profile Pharma Ltd (UK)
Industry

Bicentennial Building
Southern Gate
Chichester
PO19 8EZ
United Kingdom

Phone	+44 (0) 1243 859000
Email	info.profilepharma@zambongroup.com
Website	http://www.profilepharma.com/
"ROR"	https://ror.org/00222m642

Funders

Funder type

Industry

Profile Pharma Ltd (UK) (ref: PPCTP/001)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/04/2014		Yes	No
HRA research summary			28/06/2023	No	No