Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg

NCT01256086 | Completed Phase 2 Results

• 2 other identifiers: D-64428-3278IND #101,246
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to estimate the relative potency for bronchoprotective effect of formoterol Novolizer 12 µg (test) compared to formoterol Aerolizer 12 µg (reference).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• PC20 = Provocation Concentration of Methacholine That Cause a 20% Decrease in Forced Expiratory Volume in the First Second (FEV1)

  The primary variable is the methacholine PC20 after inhalation of study medication; the PC20 is the concentration of methacholine that - despite protection by study medication - causes a 20% fall in FEV1 compared to the pre-methacholine (post-saline) level of the given study day.

  60 min after application of study medication

Study Arms (4)

24 µg Formoterol Novolizer

EXPERIMENTAL

12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2

Drug: Formatris 24µg

12µg Formoterol Novolizer

EXPERIMENTAL

12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2

Drug: Formatris 12µg

24 µg Formoterol Aerolizer

ACTIVE COMPARATOR

Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2

Drug: Foradil P 24µg

12µg Formoterol Aerolizer

ACTIVE COMPARATOR

Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2

Drug: Foradil P 12µg

Interventions

Formatris 24µg DRUG

12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2

24 µg Formoterol Novolizer

Formatris 12µg DRUG

12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2

12µg Formoterol Novolizer

Foradil P 24µg DRUG

Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2

24 µg Formoterol Aerolizer

Foradil P 12µg DRUG

Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2

12µg Formoterol Aerolizer

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patients aged from 18 to 60 years (inclusive).
• Patients with asthma indicated by
• history of asthma symptoms and
• airway hyperresponsiveness to methacholine with a provocation concentration of methacholine that cause a 20% decrease in FEV1 (PC20) ≤8 mg/ml at Visit 1.
• Patients with stable asthma condition with baseline forced expiratory volume in the first second (FEV1) ≥70% predicted at first visit.
• The PC20 methacholine should increase at least 4-fold after inhaling 24 μg of formoterol Aerolizer (2 applications of 12 μg) at Visit 2.
• Able to be taught correct inhalation technique for both devices at screening.

You may not qualify if:

• Known hypersensitivity to formoterol, lactose, or methacholine.
• History of life-threatening asthma in the last three years.
• Major malignancies including pheochromocytoma within the last 5 years. Exception will be considered where malignancies have been resolved as judged by investigator.
• Pregnancy, breast-feeding, planned pregnancy during the study, or women of child-bearing potential not using adequate contraception. These methods include total abstinence (no sexual intercourse), oral contraceptives, an intrauterine device (IUD), an etonogestrel implant (Implanon), or medroxyprogesterone acetate injections (Depo-Provera shots). If one of these cannot be used, using contraceptive foam and a condom are recommended.
• Lack of suitability for the study:
• Screening visit 2 has to be postponed repeatedly.
• Evidence of respiratory tract infection within 4 weeks before the study (screening visit 1).
• Seasonal or episodic exposure to an allergen or occupational chemical sensitizer which are likely to vary in symptom presentation and severity during the course of the study (e.g. ragweed sensitive patients in Iowa during Aug-Oct). This does not apply to patients who can be well controlled on therapy.
• History of non-reversible pulmonary disease; chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, or pulmonary fibrosis.
• History of severe cardiovascular, renal, neurologic, liver or endocrine dysfunction (patients with well-controlled hypertension, hypercholesterolemia, thyroid disease or diabetes may be included if medication for these diseases does not affect methacholine challenge or formoterol metabolism).
• History of hemophilia or coagulation disease.
• Electrocardiogram (ECG) abnormalities of clinical relevance, in particular abnormal prolongation of QT-interval (QTc according to Bazett in women ≥450 msec, in men ≥430 msec).
• Potassium level below lower limit of laboratory normal range plus 0.3 mmol/l as safety margin.
• Exacerbation of bronchial asthma requiring emergency department visit or hospitalization during the last 3 months prior to this study.
• Prior or concomitant treatment with systemic glucocorticosteroids during the last 3 months (a short course of oral corticosteroids for asthma is permissible if for \<10 days and at least 30 days have passed).

Sponsors & Collaborators

• MEDA Pharma GmbH & Co. KG: lead
• ClinResearch, GmbH: collaborator
• Trio Clinical Research, LLC, Raleigh, USA: collaborator
• NuCara Pharmacy, Waterloo, USA: collaborator
• Prof. Hochhaus, Gainesville, USA: collaborator

Study Sites (3)

University of Florida

Gainesville, Florida, 32160-0486, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Prof. Dr. Leslie Hendeles
• Organization: University of Florida, Department of Pharmacotherapy and Tanslational Research, 100486 Gainesville, FL 32610

hendeles@cop.ufl.edu

+1 352 279

Study Officials

• Leslie Hendeles, Professor

  University of Florida, Gainesville, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 11, 2022
• Results First Posted: September 12, 2012

Record last verified: 2012-07

Locations

US (3)