Randomized, Open-Label, Active Controlled, Two-Period Crossover Study To Evaluate Relative Efficacy And Safety of Investigational Captisol-Enabled Budesonide Inhalation Solution (CBIS) Delivered via eFlow Nebuliser and Conventional Budesonide Inhalation Suspension (Pulmicort Respules) Delivered via LC Plus Jet Nebuliser in Adult Patients with Mild To Moderate Persistent Asthma - Cross-Over Safety Study with CBIS in Mild to Moderate Astmatic Adult Patients

Phase 1

Active, not recruiting

• Conditions: Asthma; MedDRA version: 8.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2006-004045-42-GB
• Lead Sponsor: Verus Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-18
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Age 16 to 60 years, inclusive, at the Screening Visit.
2.Male or female (neither pregnant nor lactating). All female subjects must have a negative urine pregnancy test immediately prior to entry into the study and must be using an acceptable means of birth control.
3.History of asthma for greater than or equivalent to 6 months prior to the Screening Visit as confirmed with clinical signs and symptoms.
4.For steroid-requiring subjects, the dose of inhaled steroid medication received prior to the Screening Visit must be less than or equal to 1000 mcg/day beclomethasone dipropionate or equivalent.
5.History of FEV1 of > 60% of predicted normal values following appropriate withholding of inhaled beta-agonist and corticosteroid medication. Predicted FEV1 will be obtained by using the normal prediction equations of ERS
6.Airway responsiveness to methacholine demonstrated by a provocation concentration causing 10% decrease in FEV1 (PC10) < 4 mg/mL at the Baseline Visit prior to entering Treatment Period 1.
7.Demonstrate ability to use a peak flow meter.
8.Meet two of the following criteria, as recorded by the subject during the Run-In Period on their Diary Cards, for 1 week immediately prior to the Baseline Visit/Treatment Period 1:
a.Use of two or more puffs per day of rescue salbutamol for at least 3 days,
b.One of the following asthma symptoms: at least one night with sleep disturbance, at least 3 days with asthma symptoms.
9.Must otherwise be healthy as judged by general physical examination, medical history and routine clinical laboratory screening.
10.Provide written informed consent (parent or legal guardian) and, as appropriate, subject assent.
11.Willing to discontinue current treatment and able to attend scheduled visits and complete the entire study.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of life-threatening asthma. This category includes those subjects with a history of systemic corticosteroid treatment within 3 months of study entry or near-fatal asthma requiring intubation or a hospitalisation or an Urgent Care Facility visit for asthma in the past year.
2. Current evidence or history of any clinically significant disease or abnormality. Clinically significant” is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
3. History of concomitant lung disease.
4. An upper or lower respiratory tract infection within 4 weeks prior to the Screening Visit.
5. If more than 12 puffs of salbutamol, per day, are used.
6. Current evidence or history of hypersensitivity or idiosyncratic reaction to inhaled budesonide or any medication.
7. Receipt of an investigational drug within 30 days of the Screening Visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified