Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) (RESPIRE 1)

Bayer

Status and phase: Completed; Phase 3

Conditions: Bronchiectasis

Treatments: Drug: Ciprofloxacin DPI (BAYQ3939); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764841

2011-004208-39 (EudraCT Number)

15625

Details and patient eligibility

About

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 for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.

Full description

Number of participants with Adverse events will be covered in Adverse Events section.

The statistical analysis tests for the efficacy variables will be performed hierarchically. The comparisons ciprofloxacin DPI vs. pooled placebo (according to statistical analysis plan defined for FDA registration) will be performed in parallel for the regimen 28 days on/off and 14 days on/off.

Enrollment: 416 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a proven and documented diagnosis of non Cystic Fibrosis (CF) idiopathic or post infectious bronchiectasis
• Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks

Exclusion criteria

• Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted
• Active allergic bronchopulmonary aspergillosis
• Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis
• Primary diagnosis of Chronic obstructive pulmonary disease (COPD)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

416 participants in 4 patient groups, including a placebo group

Ciprofloxacin DPI 28 Days on/off (Cipro 28)

Experimental group

Description:

Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).

Treatment:

Drug: Ciprofloxacin DPI (BAYQ3939)

Ciprofloxacin DPI 14 Days on/off (Cipro 14)

Experimental group

Description:

Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).

Treatment:

Drug: Ciprofloxacin DPI (BAYQ3939)

Placebo 28 Days on/off (Placebo 28)

Placebo Comparator group

Description:

Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).

Treatment:

Drug: Placebo

Placebo 14 Days on/off (Placebo 14)

Placebo Comparator group

Description:

Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).

Treatment:

Drug: Placebo