AsthmaPhase 1/2NCT01025648

Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.

A Phase 1/2 study testing E004 (epinephrine inhalation aerosol), 90 mcg/actuation, E004 (epinephrine inhalation aerosol), 125 mcg and E004 (epinephrine inhalation aerosol), 220 mcg in people with Asthma, run by Amphastar Pharmaceuticals, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The main objective of this study is to evaluate the efficacy and safety of the Armstrong's Epinephrine HFA-MDI (E004) formulation, in comparison to the Placebo (Placebo-HFA) and an Active Control (Epinephrine CFC-MDI), and to identify the optimum E004 dose strength(s) for the ensuing pivotal clinical trials. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Asthma
What is being tested?: E004 (epinephrine inhalation aerosol), 90 mcg/actuation, E004 (epinephrine inhalation aerosol), 125 mcg and E004 (epinephrine inhalation aerosol), 220 mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9 participants
Where: 2 sitesUnited States
Study dates: Dec 2009to Dec 2009
Phase: Phase 1/2
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Generally healthy, male and female adults aged 18 to 55 years at Screening.
Clinical diagnosis of intermittent, or mild-to-moderate persistent, asthma for at least 6 months before Screening, and having used inhaled epinephrine or β-agonist(s) for asthma control;
Demonstrating a baseline forced expiratory volume in 1 second (FEV1) at 50-90 percent of predicted normal at Screening;
Demonstrating a 12.0 percent or greater airway reversibility in FEV1 within 30 min after inhaling 2 actuations of Epinephrine CFC-MDI (440 mcg Epinephrine base) at Screening;
Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
Demonstration of proficiency in the use of a MDI inhaler after training;
Having properly consented to participate in the trial.

Who cannot join

A smoking history of 10 or more pack-years, or having smoked within 6 months prior to Screening;
Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
Asthma exacerbations that required emergency care or hospitalized treatment, within 4 wk prior to Screening;
Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma;
Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine (including diabetes), psychiatric, neoplastic or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study;
Known intolerance or hypersensitivity to any of the study MDI ingredients (i.e., Epinephrine, HFA-134a, CFC-12, CFC-114, polysorbate-80, ethanol, thymol, nitric acid and ascorbic acid);
Use of prohibited drugs or failure to observe the drug washout restrictions;
Having been on other investigational drug/device studies in the last 30 days prior to Screening.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Amphastar Site 0001
San Jose, California, 95117
Amphastar Site 0003
Stockton, California, 95207

Other trials in United States

About this study

Official title: A Randomized, Double-blinded or Evaluator-blinded, Placebo and Active Controlled, Six-arm, Crossover, Single Dose, Dose-ranging Study, for Initial Evaluation of Safety and Efficacy in Asthma Patients

The bronchodilatory efficacy of E004, is evaluated in terms of post-dose area under the curves (AUC) of FEV1 changes (% and volumes), from the pre-dose baseline values, in comparison to the Placebo Control and the Active Control.

Conditions: Asthma
Being tested: E004 (epinephrine inhalation aerosol), 90 mcg/actuation, E004 Placebo, E004 (epinephrine inhalation aerosol), 125 mcg, E004 (epinephrine inhalation aerosol), 220 mcg, epinephrine inhalation aerosol, CFC propelled
Keywords: Mild to Moderate Asthma, Dyspnea, Wheezing, Status Asthmaticus
Medical subject headings: Asthma, Dyspnea, Respiratory Sounds, Status Asthmaticus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E004 (epinephrine inhalation aerosol), 90 mcg/actuationDrug
Also called Primatene Mist HFA
E004 (epinephrine inhalation aerosol), 90 mcg/actuation, 2 actuations, single dose crossover, 1 -14 day washout period
E004 PlaceboDrug
E004 Placebo, 0 mcg epinephrine inhalation aerosol, 2 actuations, 1 -14 day washout period
E004 (epinephrine inhalation aerosol), 125 mcgDrug
Also called Primatene Mist HFA
E004 (epinephrine inhalation aerosol), 125 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period
E004 (epinephrine inhalation aerosol), 220 mcgDrug
Also called Primatene Mist HFA
E004 (epinephrine inhalation aerosol), 220 mcg - 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period
epinephrine inhalation aerosol, CFC propelledDrug
Also called Primatene Mist
epinephrine inhalation aerosol, 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period
E004 (epinephrine inhalation aerosol), 160 mcgDrug
Also called Primatene Mist HFA
E004 (epinephrine inhalation aerosol), 160 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period

Study groups in NCT01025648
Study group	Role	What they receive
T1 - E004 90 mcg/actuation	Experimental	T1 - E004 (epinephrine inhalation aerosol) 90 mcg/actuation - treatment by 2 actuations of E004 at 90 mcg/actuation Receives: Drug: E004 (epinephrine inhalation aerosol), 90 mcg/actuation
T2 - E004 125 mcg/actuation	Experimental	E004 (epinephrine inhalation aerosol), 125 mcg, 2 actuations Receives: Drug: E004 (epinephrine inhalation aerosol), 125 mcg
T3 - 160 mcg/actuation	Experimental	E004 (epinephrine inhalation aerosol), 160 mcg - E004 (epinephrine inhalation aerosol), 160 mcg/ actuation, 2 actuations Receives: Drug: E004 (epinephrine inhalation aerosol), 160 mcg
T4 - 220 mcg/actuation	Experimental	E004 (epinephrine inhalation aerosol), 220 mcg - 220 mcg/actuation, 2 actuations Receives: Drug: E004 (epinephrine inhalation aerosol), 220 mcg
A - Active control	Active comparator	epinephrine inhalation aerosol, CFC propelled 220 mcg Epinephrine Inhalation Aerosol, CFC-MDI, 2 actuations Receives: Drug: epinephrine inhalation aerosol, CFC propelled
P, Placebo HFA	Placebo comparator	E004 placebo single treatment with 2 inhalations Receives: Drug: E004 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The AUC of post-dose FEV1 percentage changes (Δ%) from the Pre-dose baseline. The primary analysis of the primary endpoint is the difference of Δ% FEV1, compared between the E004 treatment arms (T1, T2, T3 and T4) and the Placebo control (Arm P).
Measured: 360 minutes post-dose

Secondary outcomes (12)

Dose response relationship of Epinephrine HFA-MDI, analyzed using efficacy data from all E004 doses.
Measured: 360 minutes post dose
AUC of FEV1 volume post-dose changes (Δ Volume) from the Pre-dose baseline.
Measured: 360 minutes post dose
Time to onset of bronchodilator effect, determined by linear interpolation as the point where FEV1 first reaches 12.0 percent from the Pre-dose Baseline.
Measured: 30 (±5) min post-dose
The peak bronchodilator response (Fmax), defined as the maximum post-dose FEV1 percent change.
Measured: 360 minutes post dose
The time to peak FEV1 effect (Tmax), defined as the time of Fmax.
Measured: 360 minutes post dose
Duration of effect, calculated as the total duration of bronchodilator effects when post-dose FEV1 reaches and stays 12.0 percent above the Pre-dose Baseline.
Measured: 360 minutes post dose
Response Rate of responders who demonstrate 12.0 percent or greater FEV1 changes from the Pre-dose baseline.
Measured: 360 minutes post dose
Vital signs, i.e., blood pressure and heart rate,at Screening baseline and 15(±5) min post dosing for reversibility
Measured: screening and 15 minutes post dose
Vital signs, i.e., blood pressure (SBP/DBP) and heart rate (HR), at: Pre-dose baseline, and 15(±5) min and 360(±15) post-dose, at each Study Visit.
Measured: 360 minutes post dose
Post-dose 20(±5) min ECG recordings (Routine and QT, QTc analysis) at each Study Visit, compared to the Screening baseline recording.
Measured: 20 minutes post dose
Data for physical examinations, CBC, serum comprehensive metabolic panel, and urinalysis for all subjects, and urinary pregnancy test for women of child-bearing potential
Measured: Screening and end of study
Monitoring of adverse drug events (ADE)
Measured: Ongoing through End of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Dec 2009

First posted3 Dec 2009 (estimated)
Study startDec 2009
Primary completionDec 2009
Study completionDec 2009

Why it stopped: Optimization of protocol

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01025648
Sponsor's protocol ID: API-E004-CL-A
Status last verified: May 2018
First submitted: 1 Dec 2009
Last updated: 16 May 2018
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 2019665
Hendeles 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 16400891
Warren 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 3780129
Cripps 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 10919679
Dickinson 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 10936150
Simons 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 11061773
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882
Crapo RO, Morris AH, Clayton PD, Nixon CR. Lung volumes in healthy nonsmoking adults. Bull Eur Physiopathol Respir. 1982 May-Jun;18(3):419-25.
PubMed 7074238
Dauphinee B, Tashkin DP, et al: Placebo-controlled evaluation of the speed of onset of epinephrine metered-dose aerosol (Primatene Mist) in mild to moderate asthmatics. Am J Respir Crit Care Med, 149:A204, 1994
Armstrong Pharmaceuticals: Package Insert of Epinephrine Inhalation Aerosol USP, a CFC-MDI, current as of 2008
Westfall TC, Westfall DP: Adrenergic agonists and antagonists, in Brunton LL, Lazo JS, Parker KL (eds): Goodman & Gilman's Ther Pharmacological Basis of Therapeitucs, 11th Ed. P237-296, 1986
Montreal Protocol on substances that deplete the ozone layer, Montreal, Spet 1987; Adjusted and/or amended in London 1990; Copenhagen 1992; Vienna 1995; Montreal 1997 and Beijing 1999.
NHLBI/NAEPP (National Heart, Lund and Blood Institute; Natuinak /asthma Education and Prevention Program) Expert Panel Report 3 (2007): Guidelines for the diagnosis and management of asthma, Section 3, Component 1, Figure 3-4C:
Wyeth Consumer Healthcare: 2005N-0374, Use of ozone-depleting substances: Essential-use determination of over-the-counter (OTC) epinephrine metered dose inhalers. Submitted to teh Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees. Dec 2005.
Global Initiative for Asthma (GINA): Pocket guide for asthma management and prevention,

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
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Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blinded or Evaluator-blinded, Placebo and Active Controlled, Six-arm, Crossover, Single Dose, Dose-ranging Study, for Initial Evaluation of Safety and Efficacy in Asthma Patients
ClinicalTrials.gov ID: NCT01025648
Acronym / sponsor ID: API-E004-CL-A
Conditions: Asthma
Keywords: Mild to Moderate Asthma, Dyspnea, Wheezing, Status Asthmaticus
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Optimization of protocol
Enrolment: 9 participants (actual)
Lead sponsor: Amphastar Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 3 Dec 2009 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
T1 - E004 90 mcg/actuation	Experimental	Drug: E004 (epinephrine inhalation aerosol), 90 mcg/actuationT1 - E004 (epinephrine inhalation aerosol) 90 mcg/actuation - treatment by 2 actuations of E004 at 90 mcg/actuation
T2 - E004 125 mcg/actuation	Experimental	Drug: E004 (epinephrine inhalation aerosol), 125 mcgE004 (epinephrine inhalation aerosol), 125 mcg, 2 actuations
T3 - 160 mcg/actuation	Experimental	Drug: E004 (epinephrine inhalation aerosol), 160 mcgE004 (epinephrine inhalation aerosol), 160 mcg - E004 (epinephrine inhalation aerosol), 160 mcg/ actuation, 2 actuations
T4 - 220 mcg/actuation	Experimental	Drug: E004 (epinephrine inhalation aerosol), 220 mcgE004 (epinephrine inhalation aerosol), 220 mcg - 220 mcg/actuation, 2 actuations
A - Active control	Active comparator	Drug: epinephrine inhalation aerosol, CFC propelledepinephrine inhalation aerosol, CFC propelled 220 mcg Epinephrine Inhalation Aerosol, CFC-MDI, 2 actuations
P, Placebo HFA	Placebo comparator	Drug: E004 PlaceboE004 placebo single treatment with 2 inhalations

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Generally healthy, male and female adults aged 18 to 55 years at Screening.
Clinical diagnosis of intermittent, or mild-to-moderate persistent, asthma for at least 6 months before Screening, and having used inhaled epinephrine or β-agonist(s) for asthma control;
Demonstrating a baseline forced expiratory volume in 1 second (FEV1) at 50-90 percent of predicted normal at Screening;
Demonstrating a 12.0 percent or greater airway reversibility in FEV1 within 30 min after inhaling 2 actuations of Epinephrine CFC-MDI (440 mcg Epinephrine base) at Screening;
Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;

Key exclusion criteria (8 listed)

A smoking history of 10 or more pack-years, or having smoked within 6 months prior to Screening;
Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
Asthma exacerbations that required emergency care or hospitalized treatment, within 4 wk prior to Screening;
Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma;
Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine (including diabetes), psychiatric, neoplastic or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study;

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
E004 (epinephrine inhalation aerosol), 90 mcg/actuationAlso: Primatene Mist HFAE004 (epinephrine inhalation aerosol), 90 mcg/actuation, 2 actuations, single dose crossover, 1 -14 day washout period	Drug	T1 - E004 90 mcg/actuation
E004 PlaceboE004 Placebo, 0 mcg epinephrine inhalation aerosol, 2 actuations, 1 -14 day washout period	Drug	P, Placebo HFA
E004 (epinephrine inhalation aerosol), 125 mcgAlso: Primatene Mist HFAE004 (epinephrine inhalation aerosol), 125 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period	Drug	T2 - E004 125 mcg/actuation
E004 (epinephrine inhalation aerosol), 220 mcgAlso: Primatene Mist HFAE004 (epinephrine inhalation aerosol), 220 mcg - 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period	Drug	T4 - 220 mcg/actuation
epinephrine inhalation aerosol, CFC propelledAlso: Primatene Mistepinephrine inhalation aerosol, 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period	Drug	A - Active control
E004 (epinephrine inhalation aerosol), 160 mcgAlso: Primatene Mist HFAE004 (epinephrine inhalation aerosol), 160 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period	Drug	T3 - 160 mcg/actuation

Primary outcome

The AUC of post-dose FEV1 percentage changes (Δ%) from the Pre-dose baseline. The primary analysis of the primary endpoint is the difference of Δ% FEV1, compared between the E004 treatment arms (T1, T2, T3 and T4) and the Placebo control (Arm P).
Time frame: 360 minutes post-dose

12 secondary outcomes

Dose response relationship of Epinephrine HFA-MDI, analyzed using efficacy data from all E004 doses.
Time frame: 360 minutes post dose
AUC of FEV1 volume post-dose changes (Δ Volume) from the Pre-dose baseline.
Time frame: 360 minutes post dose
Time to onset of bronchodilator effect, determined by linear interpolation as the point where FEV1 first reaches 12.0 percent from the Pre-dose Baseline.
Time frame: 30 (±5) min post-dose
The peak bronchodilator response (Fmax), defined as the maximum post-dose FEV1 percent change.
Time frame: 360 minutes post dose
The time to peak FEV1 effect (Tmax), defined as the time of Fmax.
Time frame: 360 minutes post dose
Duration of effect, calculated as the total duration of bronchodilator effects when post-dose FEV1 reaches and stays 12.0 percent above the Pre-dose Baseline.
Time frame: 360 minutes post dose
Response Rate of responders who demonstrate 12.0 percent or greater FEV1 changes from the Pre-dose baseline.
Time frame: 360 minutes post dose
Vital signs, i.e., blood pressure and heart rate,at Screening baseline and 15(±5) min post dosing for reversibility
Time frame: screening and 15 minutes post dose
Vital signs, i.e., blood pressure (SBP/DBP) and heart rate (HR), at: Pre-dose baseline, and 15(±5) min and 360(±15) post-dose, at each Study Visit.
Time frame: 360 minutes post dose
Post-dose 20(±5) min ECG recordings (Routine and QT, QTc analysis) at each Study Visit, compared to the Screening baseline recording.
Time frame: 20 minutes post dose
Data for physical examinations, CBC, serum comprehensive metabolic panel, and urinalysis for all subjects, and urinary pregnancy test for women of child-bearing potential
Time frame: Screening and end of study
Monitoring of adverse drug events (ADE)
Time frame: Ongoing through End of Study

Results and safety

The study was stopped early (reason given: Optimization of protocol). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
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 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 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 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
Background: PubMed 7074238Crapo RO, Morris AH, Clayton PD, Nixon CR. Lung volumes in healthy nonsmoking adults. Bull Eur Physiopathol Respir. 1982 May-Jun;18(3):419-25.
BackgroundDauphinee B, Tashkin DP, et al: Placebo-controlled evaluation of the speed of onset of epinephrine metered-dose aerosol (Primatene Mist) in mild to moderate asthmatics. Am J Respir Crit Care Med, 149:A204, 1994
BackgroundArmstrong Pharmaceuticals: Package Insert of Epinephrine Inhalation Aerosol USP, a CFC-MDI, current as of 2008
BackgroundWestfall TC, Westfall DP: Adrenergic agonists and antagonists, in Brunton LL, Lazo JS, Parker KL (eds): Goodman & Gilman's Ther Pharmacological Basis of Therapeitucs, 11th Ed. P237-296, 1986
BackgroundMontreal Protocol on substances that deplete the ozone layer, Montreal, Spet 1987; Adjusted and/or amended in London 1990; Copenhagen 1992; Vienna 1995; Montreal 1997 and Beijing 1999.

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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.

Jim Shi, M.D., Ph.D. study chair

Amphastar Pharmaceuticals, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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: stopped early, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early (reason given: Optimization of protocol). Results are not available in the source record.

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?

The AUC of post-dose FEV1 percentage changes (Δ%) from the Pre-dose baseline. The primary analysis of the primary endpoint is the difference of Δ% FEV1, compared between the E004 treatment arms (T1, T2, T3 and T4) and the Placebo control (Arm P). (time frame: 360 minutes post-dose). 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 NCT01025648, which also lists 16 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 16 May 2018.