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

This study has been completed.
Sponsor:
Collaborators:
ClinResearch GmbH, Cologne, Germany
Trio Clinical Research, LLC, Raleigh, USA
NuCara Pharmacy, Waterloo, USA
Prof. Hochhaus, Gainesville, USA
Information provided by (Responsible Party):
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01256086
First received: December 7, 2010
Last updated: August 13, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention Phase
Asthma
Drug: Formatris 24µg
Drug: Formatris 12µg
Drug: Foradil P 24µg
Drug: Foradil P 12µg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg in Patients With Stable Asthma Using Bronchoprovocation With Methacholine as a Bioassay Randomized, Double-blind, Four-period, Four-sequence Cross-over Trial

Resource links provided by NLM:


Further study details as provided by MEDA Pharma GmbH & Co. KG:

Primary Outcome Measures:
  • PC20 = Provocation Concentration of Methacholine That Cause a 20% Decrease in Forced Expiratory Volume in the First Second (FEV1) [ Time Frame: 60 min after application of study medication ] [ Designated as safety issue: No ]
    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.


Enrollment: 44
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 24 µg Formoterol Novolizer
12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
Drug: Formatris 24µg
12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
Experimental: 12µg Formoterol Novolizer
12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
Drug: Formatris 12µg
12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
Active Comparator: 24 µg Formoterol Aerolizer
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
Drug: Foradil P 24µg
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
Active Comparator: 12µg Formoterol Aerolizer
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
Drug: Foradil P 12µg
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged from 18 to 60 years (inclusive).
  2. 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.
  3. Patients with stable asthma condition with baseline forced expiratory volume in the first second (FEV1) ≥70% predicted at first visit.
  4. The PC20 methacholine should increase at least 4-fold after inhaling 24 μg of formoterol Aerolizer (2 applications of 12 μg) at Visit 2.
  5. Able to be taught correct inhalation technique for both devices at screening.

Exclusion Criteria:

  1. Known hypersensitivity to formoterol, lactose, or methacholine.
  2. History of life-threatening asthma in the last three years.
  3. Major malignancies including pheochromocytoma within the last 5 years. Exception will be considered where malignancies have been resolved as judged by investigator.
  4. 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:

  5. Screening visit 2 has to be postponed repeatedly.
  6. Evidence of respiratory tract infection within 4 weeks before the study (screening visit 1).
  7. 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.
  8. History of non-reversible pulmonary disease; chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, or pulmonary fibrosis.
  9. 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).
  10. History of hemophilia or coagulation disease.
  11. 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).
  12. Potassium level below lower limit of laboratory normal range plus 0.3 mmol/l as safety margin.
  13. Exacerbation of bronchial asthma requiring emergency department visit or hospitalization during the last 3 months prior to this study.
  14. 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).
  15. Use of long-acting ß2-agonists in last 3 weeks before the first methacholine challenge or during the study
  16. Change in dosage of other controller therapy (inhaled glucocorticosteroids, leukotriene modifier, slow-release theophylline) during the last 3 weeks before the first methacholine challenge or during the study.
  17. Use of short-acting ß2-agonists more than thrice a week in the previous month.
  18. Inability to temporary withhold the following medications/substances before lung function test:

    • short-acting ß2-agonists and short-acting anticholinergics at least 6 hours,
    • regular long-acting ß2-agonists at least 3 weeks,
    • long-acting anticholinergics at least 36 hours,
    • inhaled glucocorticosteroids at least 2 hours
    • Disodium cromoglycate (DSCG) at least 24 hours,
    • slow release theophylline at least 48 hours,
    • rapid release theophylline at least 24 hours,
    • caffeine at least 4 hours
  19. Patients with aspirin induced bronchospasm.
  20. Any treatment with ß2-antagonists (including eye drops).
  21. Non-cooperative patients, inability to perform outcome measurement correctly.
  22. Inability to measure PC20 methacholine after 24 μg of formoterol Aerolizer (PC20 >128 mg/ml).
  23. Current smokers or regular smokers during last 12 months or more than 10 pack-year history.
  24. Drug or alcohol abuse which would interfere with the patient's proper completion of the protocol assignment.

    Administrative reasons:

  25. Participation in another clinical study within 1 month prior to or during this study
  26. Lack of ability or willingness to give informed consent.
  27. Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
  28. Personnel involved in the planning or conduct of the study.
  29. Anticipated non-availability for study visits/procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256086

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32160-0486
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
ClinResearch GmbH, Cologne, Germany
Trio Clinical Research, LLC, Raleigh, USA
NuCara Pharmacy, Waterloo, USA
Prof. Hochhaus, Gainesville, USA
Investigators
Principal Investigator: Leslie Hendeles, Professor University of Florida, Gainesville, USA
  More Information

No publications provided

Responsible Party: MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01256086     History of Changes
Other Study ID Numbers: D-64428-3278, IND #101,246
Study First Received: December 7, 2010
Results First Received: July 26, 2012
Last Updated: August 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014