AsthmaPhase 3NCT01476904
Safety Study in Adolescent and Adult Patients With Asthma
A Phase 3 study testing Primatene Mist and Epinephrine inhalation in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 27 sites in United States.
Trial summary
E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Primatene Mist and Epinephrine inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 27 sitesUnited States
- Study dates
- Nov 2011to Jul 2012
- Phase
- Phase 3
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation
- Male and female asthma patients aged 12 - 75 years
- Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment
- No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening
- Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter
- Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study
Who cannot join
- A smoking history of 10-pack years, or having smoked within 12 months of screening
- Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma
- Concurrent clinically significant diseases
- Known intolerance or hypersensitivity to any component of the study drugs
- Recent infection of the respiratory tract, before screening
- Use of prohibited medications
- Having been on other investigational drug/device studies in the last 30 days prior to screening
- Known or highly suspected substance abuse
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Amphastar Site 0024
Ashland, Oregon, 97520
Amphastar Site 0019
Bellevue, Nebraska, 68123
Amphastar Site 0017
Bozeman, Montana, 59718
Amphastar Site 0021
Cincinnati, Ohio, 45242
Amphastar Site 0006
Costa Mesa, California, 92626
Amphastar Site 0008
Denver, Colorado, 80230
Amphastar Site 0031
El Paso, Texas, 79903
Amphastar Site 0022
Eugene, Oregon, 97401
Amphastar Site 0011
Iowa City, Iowa, 52240
Amphastar Site 0023
Lake Oswego, Oregon, 97035
Amphastar Site 0005
Los Angeles, California, 90048
Amphastar Site 0025
Medford, Oregon, 97504
Amphastar Site 0014
Minneapolis, Minnesota, 55402
Amphastar Site 0030
New Braunfels, Texas, 78130
Amphastar Site 0029
North Charleston, South Carolina, 29406
Amphastar Site 0013
North Dartmouth, Massachusetts, 02747
Amphastar Site 0004
Orange, California, 92868
Amphastar Site 0015
Plymouth, Minnesota, 55441
Amphastar Site 0026
Portland, Oregon, 97202
Amphastar Site 0018
Raleigh, North Carolina, 27607
Amphastar Site 0033
Richmond, Virginia, 23229
Amphastar Site 0001
San Jose, California, 95117
Amphastar Site 0034
Seattle, Washington, 98105
Amphastar Site 0020
Skillman, New Jersey, 08558
Amphastar Site 0016
St Louis, Missouri, 63141
Amphastar Site 0003
Stockton, California, 95207
Amphastar Site 0009
Wheat Ridge, Colorado, 80033
About this study
Official title: A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma)
E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.
- Conditions
- Asthma
- Being tested
- Placebo, Primatene Mist, Epinephrine inhalation
- Keywords
- Asthma, Bronchial Asthma, Shortness of breath
- Medical subject headings
- Asthma, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
0 mcg/inhalation, 2 inhalations QID
Primatene MistDrug
220 mcg/inhalation, 2 inhalations QID
Epinephrine inhalationDrug
125 mcg/inhalation, 2 inhalations QID
| Study group | Role | What they receive |
|---|---|---|
| Arm T | Experimental | Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of epinephrine inhalation, QID, with 4-6 hr intervals Receives: Drug: Epinephrine inhalation |
| Arm P | Placebo comparator | Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals Receives: Drug: Placebo |
| Arm A | Active comparator | Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals Receives: Drug: Primatene Mist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Recording of all adverse events experienced during the course of the study
Measured: up to 12 weeks
Secondary outcomes (2)
Change in 12 lead ECG including QT/QTc analysis
A 12-lead ECG (routine and QT/QTc) will be measured and recorded, provided that dosing of study drug has been performed greater than 1 hour prior to conducting the measurements.
Measured: Study visit 4, 8 and 12, greater than one hour after last dose
Asthma Exacerbations
Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Safety Monitor, Study director, Amphastar Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476904
- Sponsor's protocol ID
- API-E004-CL-C2
- Status last verified
- Feb 2017
- First submitted
- 15 Nov 2011
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Pinnas JL, Schachtel BP, Chen TM, Roseberry HR, Thoden WR. Inhaled epinephrine and oral theophylline-ephedrine in the treatment of asthma. J Clin Pharmacol. 1991 Mar;31(3):243-7. doi: 10.1002/j.1552-4604.1991.tb04969.x.
PubMed 2019665Hendeles L, Marshik PL, Ahrens R, Kifle Y, Shuster J. Response to nonprescription epinephrine inhaler during nocturnal asthma. Ann Allergy Asthma Immunol. 2005 Dec;95(6):530-4. doi: 10.1016/S1081-1206(10)61014-9.
PubMed 16400891Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8. doi: 10.1038/clpt.1986.243.
PubMed 3780129Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 2000 Jun;94 Suppl B:S3-9.
PubMed 10919679Simons FE, Gu X, Johnston LM, Simons KJ. Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? Pediatrics. 2000 Nov;106(5):1040-4. doi: 10.1542/peds.106.5.1040.
PubMed 11061773Dickinson BD, Altman RD, Deitchman SD, Champion HC. Safety of over-the-counter inhalers for asthma: report of the council on scientific affairs. Chest. 2000 Aug;118(2):522-6. doi: 10.1378/chest.118.2.522.
PubMed 10936150Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.
PubMed 9872837Kerwin EM, Tashkin DP, Korenblat PE, Greos LS, Pearlman DS, Bensch GW, Miller SD, Marrs T, Luo MZ, Zhang JY. Long-term safety and efficacy studies of epinephrine HFA metered-dose inhaler (Primatene(R) Mist): a two-stage randomized controlled trial. J Asthma. 2021 May;58(5):633-644. doi: 10.1080/02770903.2020.1713147. Epub 2020 Jan 20.
PubMed 31959019
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma)
- ClinicalTrials.gov ID
- NCT01476904
- Acronym / sponsor ID
- API-E004-CL-C2
- Conditions
- Asthma
- Keywords
- Asthma, Bronchial Asthma, Shortness of breath
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Nov 2011 (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.
E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm T | Experimental | Drug: Epinephrine inhalationArm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of epinephrine inhalation, QID, with 4-6 hr intervals |
| Arm P | Placebo comparator | Drug: PlaceboArm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals |
| Arm A | Active comparator | Drug: Primatene MistArm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation
- Male and female asthma patients aged 12 - 75 years
- Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment
- No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening
- Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter
Key exclusion criteria (8 listed)
- A smoking history of 10-pack years, or having smoked within 12 months of screening
- Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma
- Concurrent clinically significant diseases
- Known intolerance or hypersensitivity to any component of the study drugs
- Recent infection of the respiratory tract, before screening
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 |
|---|---|---|
| Placebo0 mcg/inhalation, 2 inhalations QID | Drug | Arm P |
| Primatene Mist220 mcg/inhalation, 2 inhalations QID | Drug | Arm A |
| Epinephrine inhalation125 mcg/inhalation, 2 inhalations QID | Drug | Arm T |
Primary outcome
Adverse Events
Time frame: up to 12 weeks
Recording of all adverse events experienced during the course of the study
2 secondary outcomes
Change in 12 lead ECG including QT/QTc analysis
Time frame: Study visit 4, 8 and 12, greater than one hour after last dose
Asthma Exacerbations
Time frame: up to 12 weeks
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 13 Feb 2017.
- Background: PubMed 2019665Pinnas JL, Schachtel BP, Chen TM, Roseberry HR, Thoden WR. Inhaled epinephrine and oral theophylline-ephedrine in the treatment of asthma. J Clin Pharmacol. 1991 Mar;31(3):243-7. doi: 10.1002/j.1552-4604.1991.tb04969.x.
- Background: PubMed 16400891Hendeles L, Marshik PL, Ahrens R, Kifle Y, Shuster J. Response to nonprescription epinephrine inhaler during nocturnal asthma. Ann Allergy Asthma Immunol. 2005 Dec;95(6):530-4. doi: 10.1016/S1081-1206(10)61014-9.
- Background: PubMed 3780129Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8. doi: 10.1038/clpt.1986.243.
- Background: PubMed 10919679Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 2000 Jun;94 Suppl B:S3-9.
- Background: PubMed 11061773Simons FE, Gu X, Johnston LM, Simons KJ. Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? Pediatrics. 2000 Nov;106(5):1040-4. doi: 10.1542/peds.106.5.1040.
- Background: PubMed 10936150Dickinson BD, Altman RD, Deitchman SD, Champion HC. Safety of over-the-counter inhalers for asthma: report of the council on scientific affairs. Chest. 2000 Aug;118(2):522-6. doi: 10.1378/chest.118.2.522.
- Background: PubMed 9872837Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.
- Derived from this study: PubMed 31959019Kerwin EM, Tashkin DP, Korenblat PE, Greos LS, Pearlman DS, Bensch GW, Miller SD, Marrs T, Luo MZ, Zhang JY. Long-term safety and efficacy studies of epinephrine HFA metered-dose inhaler (Primatene(R) Mist): a two-stage randomized controlled trial. J Asthma. 2021 May;58(5):633-644. doi: 10.1080/02770903.2020.1713147. Epub 2020 Jan 20.
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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.
Safety Monitor study director
Amphastar Pharmaceuticals, Inc.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Primatene Mist and Epinephrine inhalation in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 27 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 6 inclusion and 8 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 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Adverse Events (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01476904, which also lists 8 linked publications.
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 13 Feb 2017.