Ciprofloxacin in subjects with Non-Cystic Fibrosis Bronchiectasis
Research type
Research Study
Full title
Randomised, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. (RESPIRE 1)
IRAS ID
114367
Contact name
Anthony de Soyza
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2011-004208-39
Clinicaltrials.gov Identifier
Research summary
Bronchiectasis (BE) is a chronic lung disease, by which permanent dilation of the bronchi and bronchioles is caused by the destruction of muscle and elastic tissue. Symptoms include a cough that produces frequent green/yellow sputum, coughing up blood, chest pain, shortness of breath and fatigue.
BE is usually diagnosed in adults, most frequently in the middle aged and elderly. The female gender is predominantly affected. High-resolution computed tomography (HRCT) scans are considered the ‘gold standard’ in diagnosing BE. Current therapies for BE include controlling infections and bronchial secretions, relieving airway obstructions, removal of affected portions of lung by surgical procedure or artery embolization and preventing complications such as recurrent bronchial infections. This includes the prolonged usage of antibiotics.
Ciprofloxacin is an antibiotic which is given by mouth or injected into a vein and has been widely in use for years. It kills many bacteria strains which cause the frequent bronchial infections occurring in this disease..
Bayer Healthcare AG has developed an inhaled form of ciprofloxacin called ciprofloxacin DPI (Dry Powder for Inhalation). The inhaled form will allow ciprofloxacin to be inhaled directly to the site of the infection in the lungs. The use of inhaled ciprofloxacin via the inhaler is experimental.
Eligible participants will be equally randomised to one of 3 treatment groups to receive either
1. Treatment cycles of ciprofloxacin DPI (active) 28 days on/28 days off
2. Treatment cycles of ciprofloxacin DPI (active) 14 days on/14 days off
3. matching placebo (drug has no medicinal effect).
The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin over 48 weeks.This is a randomised, placebo-controlled, double-blind study meaning neither the participants nor the study doctor know which medication is being given.
This is a multicentre study which will take place across 13 countries. It is anticipated that approximately 300 participants will take part in this study.
A6-2. Summary of main issues. Please summarise the main ethical, legal, or management issues arising from your study and say how you have addressed them.
Not all studies raise significant issues. Some studies may have straightforward ethical or other issues that can be identified and managed routinely. Others may present significant issues requiring further consideration by a REC, R&D office or other review body (as appropriate to the issue). Studies that present a minimal risk to participants may raise complex organisational or legal issues. You should try to consider all the types of issues that the different reviewers may need to consider.
Study Drug:
Ciprofloxacin is a well-known antibiotic which is given by mouth or injected into a vein and has been widely in use for years. The Sponsor of this study has developed an inhaled form of ciprofloxacin called ciprofloxacin DPI (Dry Powder Inhaler). The inhaled form will allow ciprofloxacin to be inhaled directly to the site of the infection in the lungs. Inhaled ciprofloxacin given via the inhaler is in the development stages. Participants will be informed of this both verbally and in the participant information sheet. In addition safety monitoring of all participants will be conducted throughout the study.Placebo:
The study is a placebo controlled study so a proportion of participants will receive no active ingredient. This is necessary in order to provide a comparison for participants treated with the study medication. Participants will be informed of this both verbally and in the participant information sheet. Participants will be reminded they are free to withdraw from the study at any time.Additional Procedures:
There are several procedures in the study which are not routine for patients suffering from bronchiectasis or are undertaken more frequently than they would be during routine clinical care (nasal swabs, blood samples, pulmonary function testing etc).
Despite this, the risks associated with the procedures are no greater during the study than they would be during routine clinical care. All study procedures will be carried out by fully trained and experienced members of staff.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
13/NE/0115
Date of REC Opinion
30 May 2013
REC opinion
Further Information Favourable Opinion