AsthmaPhase 2NCT01256086
Relative Potency of Formoterol Novolizer® 12 µg Compared to Formoterol Aerolizer® 12 µg
A Phase 2 study testing Formatris 24µg, Formatris 12µg and Foradil P 24µg in people with Asthma, run by MEDA Pharma GmbH & Co. KG at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Formatris 24µg, Formatris 12µg and Foradil P 24µg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2010to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- Use of long-acting ß2-agonists in last 3 weeks before the first methacholine challenge or during the study
- 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.
- Use of short-acting ß2-agonists more than thrice a week in the previous month.
- 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
- Patients with aspirin induced bronchospasm.
- Any treatment with ß2-antagonists (including eye drops).
- Non-cooperative patients, inability to perform outcome measurement correctly.
- Inability to measure PC20 methacholine after 24 μg of formoterol Aerolizer (PC20 >128 mg/ml).
- Current smokers or regular smokers during last 12 months or more than 10 pack-year history.
- Drug or alcohol abuse which would interfere with the patient's proper completion of the protocol assignment.
- Administrative reasons:
- Participation in another clinical study within 1 month prior to or during this study
- Lack of ability or willingness to give informed consent.
- Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
- Personnel involved in the planning or conduct of the study.
- Anticipated non-availability for study visits/procedures.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida
Gainesville, Florida, 32160-0486
University of Iowa
Iowa City, Iowa, 52242
University of Wisconsin
Madison, Wisconsin, 53705
About this study
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
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
- Being tested
- Formatris 24µg, Formatris 12µg, Foradil P 24µg, Foradil P 12µg
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formatris 24µgDrug
12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
Formatris 12µgDrug
12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
Foradil P 24µgDrug
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
Foradil P 12µgDrug
Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
| Study group | Role | What they receive |
|---|---|---|
| 24 µg Formoterol Novolizer | Experimental | 12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 Receives: Drug: Formatris 24µg |
| 12µg Formoterol Novolizer | Experimental | 12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 Receives: Drug: Formatris 12µg |
| 24 µg Formoterol Aerolizer | Active comparator | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 Receives: Drug: Foradil P 24µg |
| 12µg Formoterol Aerolizer | Active comparator | Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2 Receives: Drug: Foradil P 12µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 min after application of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinResearch, GmbH, Trio Clinical Research, LLC, Raleigh, USA, NuCara Pharmacy, Waterloo, USA, Prof. Hochhaus, Gainesville, USA
- Responsible party
- Sponsor
- Investigators
- Leslie Hendeles, Professor, Principal investigator, University of Florida, Gainesville, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256086
- Sponsor's protocol ID
- D-64428-3278
- Other IDs
- IND #101,246
- Status last verified
- Jul 2012
- First submitted
- 7 Dec 2010
- Last updated
- 11 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01256086
- Acronym / sponsor ID
- D-64428-3278
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- ClinResearch, GmbH, Trio Clinical Research, LLC, Raleigh, USA, NuCara Pharmacy, Waterloo, USA, Prof. Hochhaus, Gainesville, USA
- Study start
- Dec 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Dec 2010 (estimated)
- Results
- Posted 12 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 24 µg Formoterol Novolizer | Experimental | Drug: Formatris 24µg12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| 12µg Formoterol Novolizer | Experimental | Drug: Formatris 12µg12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 |
| 24 µg Formoterol Aerolizer | Active comparator | Drug: Foradil P 24µgPlacebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 |
| 12µg Formoterol Aerolizer | Active comparator | Drug: Foradil P 12µgPlacebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female patients aged from 18 to 60 years (inclusive).
- Patients with asthma indicated by
- 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.
Key exclusion criteria (39 listed)
- 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.
- Screening visit 2 has to be postponed repeatedly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formatris 24µg12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 | Drug | 24 µg Formoterol Novolizer |
| Formatris 12µg12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2 | Drug | 12µg Formoterol Novolizer |
| Foradil P 24µgPlacebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2 | Drug | 24 µg Formoterol Aerolizer |
| Foradil P 12µgPlacebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2 | Drug | 12µg Formoterol Aerolizer |
Primary outcome
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Hendeles, Professor principal investigator
University of Florida, Gainesville, USA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Formatris 24µg, Formatris 12µg and Foradil P 24µg in people with Asthma, run by MEDA Pharma GmbH & Co. KG at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.