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

Aradigm

Status and phase: Completed; Phase 2

Conditions: Non-Cystic Fibrosis Bronchiectasis

Treatments: Drug: Placebo; Drug: Ciprofloxacin for Inhalation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00889967

ARD-3100-0901

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Ciprofloxacin for Inhalation 100 mg/day by inhalation

Treatment:

Drug: Ciprofloxacin for Inhalation

Drug: Ciprofloxacin for Inhalation

2

Experimental group

Description:

Ciprofloxacin for inhalation 150 mg/day by inhalation

Treatment:

Drug: Ciprofloxacin for Inhalation

Drug: Ciprofloxacin for Inhalation

Placebo

Placebo Comparator group

Description:

Placebo by inhalation

Treatment:

Drug: Placebo