Asthma, Exercise-InducedPhase 2AERIANCT00777348
To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol
A Phase 2 study testing Combination DSCG and Reproterol in people with Asthma, Exercise-Induced, run by MEDA Pharma GmbH & Co. KG at 7 sites in Germany.
Trial summary
This is a multicentre, randomised, double-blind, placebo-controlled, 4-way cross-over study. At each study visit a standardised treadmill test will be performed to provoke EIA. Before and after the challenge test pulmonary function variables (e.g. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Exercise-Induced
- What is being tested?
- Combination DSCG and Reproterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 7 sitesGermany
- Study dates
- Nov 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male subjects aged 18 - 65 years
- Exercise induced asthma with reversible airway obstruction: twice proven EIA defined as maximum decrease in FEV1 against the baseline value of at least 20% (first test results can be obtained during the last 12 months)
- Baseline FEV1 before challenge must be > or = 70% of the predicted FEV1
Who cannot join
- Safety concerns:
- Subjects with hypersensitivity to DSCG, reproterol, menthol, peppermint or other excipients of the study medication
- Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner
- Subjects with an asthma exacerbation within 4 weeks prior to the study start. Asthma exacerbation defined as use of oral (systemic) glucocorticosteroids, unscheduled consultation of a medic due to asthma, hospitalisation, or additional treatment of asthma with antibiotics
- Eosinophilic pneumonia
- Clinically significant cardiovascular diseases (e.g. cardiac infarction, cardiac dysrhythmia, hypertrophic obstructive cardiomyopathy, coronary heart disease…)
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- Resting blood pressure over 140/90 mmHg
- Diastolic blood pressure after treadmill-test over 120 mmHg
- Malignancies including phaeochromocytoma within the last 5 years
- Severe hyperthyreosis, thyreotoxicosis, instable diabetes mellitus
- Lack of suitability for the trial:
- Subjects with seasonal asthma during their asthma season
- Infectious disease of the upper airways within 2 weeks prior to the study and within 4 weeks prior to study in case of use of antibiotics
- Relevant respiratory disorder other than asthma
- Clinically significant renal, endocrine, haematological, hepatic, immunological, gastrointestinal, neurological, or psychiatric diseases
- Any chronic disease which might influence absorption, metabolism, or excretion of the trial substances
- Change of inhalative glucocorticosteroid dosage and / or antiasthmatic controller therapy within the last 4 weeks prior to or during the study
- Concomitant systemic treatment with glucocorticosteroids
- Concomitant treatment with any ß-antagonistic drug
- Need of rescue medication within 15 min after challenge
- Concomitant therapy with antidepressants or neuroleptics
- Drug or alcohol abuse which would interfere with the subjects proper completion of the protocol assignment and mentally handicapped subjects
- Smokers within the last 6 months or smoking history > 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent)
- Exposure to another investigational agent within the last 4 weeks prior to this one or during this study
- Non-cooperative subjects not able to understand the instructions for use of the devices
- Administrative reasons:
- 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
- Anticipated non-availability for study visits / procedures
- Personnel involved in the planning or conduct of the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Kurmittelhaus der Moderne
Bad Reichenhall, D-83435
Asthma Center Buchenhoehe
Berchtesgaden, D-83471
Practice Dr. T. Ginko
Bonn, D-53119
Clinic St. Georg Leipzig, Robert Koch Clinic
Leipzig, D-04207
Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
Mainz, D-55131
Practice Dr. W. Schürmann
Marburg, D-35037
Institute for Pulmonary Research GmbH
Wiesbaden, D-65187
About this study
Official title: Clinical Trial to Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol in Comparison to the Single Components and Placebo in Adults With Exercise Induced Asthma Randomised, Placebo-controlled, Double-blind, Crossover, Multicentre Study
This is a multicentre, randomised, double-blind, placebo-controlled, 4-way cross-over study. At each study visit a standardised treadmill test will be performed to provoke EIA. Before and after the challenge test pulmonary function variables (e.g. forced expiratory volume in one second (FEV1)) will be measured in order to assess the protective effect of the study medication.
Read the detailed description
- Primary objective: to demonstrate superiority of the protective effect of the fixed combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single component reproterol in adults suffering from exercise induced asthma (EIA).
- Secondary objectives: to demonstrate superiority of the protective effect of DSCG plus reproterol in comparison to the single component DSCG; to demonstrate superiority of the protective effect of each single component in comparison to placebo. In addition, the tolerability of medications will be documented.
- Conditions
- Asthma, Exercise-Induced
- Being tested
- Combination DSCG and Reproterol
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination DSCG and ReproterolDrug
1:
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DSCG + Reproterol Receives: Drug: Combination DSCG and Reproterol |
| 2 | Active comparator | DSCG Receives: Drug: Combination DSCG and Reproterol |
| 3 | Active comparator | Reproterol Receives: Drug: Combination DSCG and Reproterol |
| 4 | Placebo comparator | Placebo Receives: Drug: Combination DSCG and Reproterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective: to demonstrate superiority of the protective effect of the fixed combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single component reproterol in adults suffering from exercise induced asthma (EIA).
Measured: 5, 10, 15, 30 and 60 minutes after drug application
Secondary outcomes (1)
Secondary objectives: to demonstrate superiority of the protective effect of DSCG plus reproterol in comparison to the single component DSCG; to demonstrate superiority of the protective effect of each single component in comparison to placebo.
Measured: 5, 10, 15, 30 and 60 minutes after drug application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, Exercise-InducedStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinResearch, GmbH, Sanofi
- Investigators
- Roland Buhl, MD, Prof., Principal investigator, Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777348
- Sponsor's protocol ID
- H-00982-3256
- Other IDs
- EudraCT No.: 2007-002553-23
- Acronym
- AERIA
- Status last verified
- Apr 2009
- First submitted
- 21 Oct 2008
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol in Comparison to the Single Components and Placebo in Adults With Exercise Induced Asthma Randomised, Placebo-controlled, Double-blind, Crossover, Multicentre Study
- ClinicalTrials.gov ID
- NCT00777348
- Acronym / sponsor ID
- AERIA / H-00982-3256
- Conditions
- Asthma, Exercise-Induced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- ClinResearch, GmbH, Sanofi
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentre, randomised, double-blind, placebo-controlled, 4-way cross-over study. At each study visit a standardised treadmill test will be performed to provoke EIA. Before and after the challenge test pulmonary function variables (e.g. forced expiratory volume in one second (FEV1)) will be measured in order to assess the protective effect of the study medication.
Detailed description
- Primary objective: to demonstrate superiority of the protective effect of the fixed combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single component reproterol in adults suffering from exercise induced asthma (EIA).
- Secondary objectives: to demonstrate superiority of the protective effect of DSCG plus reproterol in comparison to the single component DSCG; to demonstrate superiority of the protective effect of each single component in comparison to placebo. In addition, the tolerability of medications will be documented.
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 |
|---|---|---|
| 1 | Experimental | Drug: Combination DSCG and ReproterolDSCG + Reproterol |
| 2 | Active comparator | Drug: Combination DSCG and ReproterolDSCG |
| 3 | Active comparator | Drug: Combination DSCG and ReproterolReproterol |
| 4 | Placebo comparator | Drug: Combination DSCG and ReproterolPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female and male subjects aged 18 - 65 years
- Exercise induced asthma with reversible airway obstruction: twice proven EIA defined as maximum decrease in FEV1 against the baseline value of at least 20% (first test results can be obtained during the last 12 months)
- Baseline FEV1 before challenge must be > or = 70% of the predicted FEV1
Key exclusion criteria (30 listed)
- Subjects with hypersensitivity to DSCG, reproterol, menthol, peppermint or other excipients of the study medication
- Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner
- Subjects with an asthma exacerbation within 4 weeks prior to the study start. Asthma exacerbation defined as use of oral (systemic) glucocorticosteroids, unscheduled consultation of a medic due to asthma, hospitalisation, or additional treatment of asthma with antibiotics
- Eosinophilic pneumonia
- Clinically significant cardiovascular diseases (e.g. cardiac infarction, cardiac dysrhythmia, hypertrophic obstructive cardiomyopathy, coronary heart disease…)
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 |
|---|---|---|
| Combination DSCG and Reproterol1: | Drug | 1, 2, 3, 4 |
Primary outcome
Primary objective: to demonstrate superiority of the protective effect of the fixed combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single component reproterol in adults suffering from exercise induced asthma (EIA).
Time frame: 5, 10, 15, 30 and 60 minutes after drug application
1 secondary outcome
Secondary objectives: to demonstrate superiority of the protective effect of DSCG plus reproterol in comparison to the single component DSCG; to demonstrate superiority of the protective effect of each single component in comparison to placebo.
Time frame: 5, 10, 15, 30 and 60 minutes after drug application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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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.
Roland Buhl, MD, Prof. principal investigator
Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
7 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 Combination DSCG and Reproterol in people with Asthma, Exercise-Induced, run by MEDA Pharma GmbH & Co. KG at 7 sites in Germany.
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 3 inclusion and 30 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 7 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 7 sites in Germany. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary objective: to demonstrate superiority of the protective effect of the fixed combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single component reproterol in adults suffering from exercise induced asthma (EIA). (time frame: 5, 10, 15, 30 and 60 minutes after drug application). 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 7 Feb 2022.