Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00889967
  4. Details
NCT00889967 Clinical Trial

Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"

Non-Cystic Fibrosis Bronchiectasis Clinical Trial

Official title:
An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00889967
Other study ID # ARD-3100-0901
Secondary ID
Status Completed
Phase Phase 2
First received April 27, 2009
Last updated January 23, 2017
Start date February 2010
Est. completion date June 2011

Study information
Verified date August 2012
Source Aradigm Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.

Recruitment information / eligibility
Status Completed
Enrollment 95
Est. completion date June 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Are willing and able to provide written informed consent.

2. Are males or females 18 to 80 year of age, inclusive.

3. Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.

4. Confirmation of infection with P. aeruginosa at screening

Exclusion Criteria:

1. Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics.

2. Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.

3. Have a diagnosis of cystic fibrosis..

4. Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:

- Azithromycin

- Hypertonic saline

- Bronchodilator medications

- Oral corticosteroid.

5. Have received an investigational drug or device within 28 days prior to Visit 1.

6. Have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients' treatment, assessment, or compliance with the protocol.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ciprofloxacin for Inhalation
100 mg once daily by inhalation for 28 days
• Ciprofloxacin for Inhalation
150 mg once daily by inhalation for 28 days
• Placebo
Placebo once daily by inhalation for 28 days

Locations
Country Name City State
United Kingdom "Ground Floor, Tower Block, Lisburn Road Belfast Britain
United Kingdom "1st Floor, Nuffield House, B15 2TH Birmingham Britain
United Kingdom "Bordesley Green East Birmingham
United Kingdom "Duckworth Lane, Bradford Britain
United Kingdom "133 Balornock Road Glasgow
United Kingdom Royal Brompton Hospital London
United Kingdom "Southmoor Road, M23 9LT Manchester Britain
United Kingdom "Stott Lane Salford
United Kingdom "Newcastle Road Stoke on Trent
United Kingdom "Northumbria Healthcare Tyne and Wear

Sponsors (1)
Lead Sponsor Collaborator
Aradigm Corporation

Countries where clinical trial is conducted

United States,  Canada,  Germany,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28. 28 days
Secondary Microbiological efficacy 28 days
Secondary Time to, number of, severity of, and time to resolve exacerbations 28 days
Secondary Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability 28 days
Secondary Quality of life (QOL) 28 days
Secondary Safety and tolerability 28 days
See also
  Status Clinical Trial Phase
Completed NCT01792440 - The Sputum Colour Chart as a Predictor of Lung Inflammation and Proteolysis in Non-cystic Fibrosis Bronchiectasis N/A
Completed NCT05523180 - A Study to Evaluate the Effect of Probiotic Supplement on Quality of Life N/A
Completed NCT03218917 - Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis Phase 2
Completed NCT05495243 - Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-CF Bronchiectasis With Excess Mucus and Cough Phase 2
Recruiting NCT06237348 - Simeox Therapy at Home Versus Standard of Care in NCFB Patients With CMH N/A
Completed NCT03056326 - A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects Phase 1
Not yet recruiting NCT02614300 - The Role of Pulmonary Rehabilitation and Airways Clearance Techniques in the Multidisciplinary Management of Non CF Bronchiectasis N/A
Recruiting NCT04322929 - Roflumilast in Non-CF Bronchiectasis Study (2019) Phase 2
Completed NCT05369624 - Exercise Capacity in Non-cystic Fibrosis Bronchiectasis After a Pulmonary Rehabilitation Home-based Program N/A
Completed NCT04010799 - A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis Phase 1
Completed NCT03428334 - Roflumilast in Non-CF Bronchiectasis Study Phase 2
Recruiting NCT06164470 - Impact of Support Groups for Patients With Non-Cystic Fibrosis Bronchiectasis N/A
Completed NCT04656275 - A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation Phase 1
Not yet recruiting NCT06151366 - Early Detection of Pulmonary Exacerbations in Non-cystic Fibrosis Bronchiectasis
Completed NCT02081963 - Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis Phase 4
Completed NCT02883101 - The Effects of Pulmonary Rehabilitation in Patients With Non-cystic Fibrosis Bronchiectasis N/A
Completed NCT01792427 - Mortality in Non-cystic Fibrosis Bronchiectasis N/A
Recruiting NCT04278040 - Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis Bronchiectasis Phase 2
Completed NCT05006573 - Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis Phase 3
Not yet recruiting NCT06352944 - Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children