Safety Study in Adolescent and Adult Patients With Asthma

Asthma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476904
• Other study ID #: API-E004-CL-C2
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2011
• Last updated: February 10, 2017
• Start date: November 2011
• Est. completion date: July 2012

Study information

• Verified date: February 2017
• Source: Amphastar Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Placebo
0 mcg/inhalation, 2 inhalations QID
• Primatene Mist
220 mcg/inhalation, 2 inhalations QID
• Epinephrine inhalation
125 mcg/inhalation, 2 inhalations QID

Locations

Country	Name	City	State
United States	Amphastar Site 0024	Ashland	Oregon
United States	Amphastar Site 0019	Bellevue	Nebraska
United States	Amphastar Site 0017	Bozeman	Montana
United States	Amphastar Site 0021	Cincinnati	Ohio
United States	Amphastar Site 0006	Costa Mesa	California
United States	Amphastar Site 0008	Denver	Colorado
United States	Amphastar Site 0031	El Paso	Texas
United States	Amphastar Site 0022	Eugene	Oregon
United States	Amphastar Site 0011	Iowa City	Iowa
United States	Amphastar Site 0023	Lake Oswego	Oregon
United States	Amphastar Site 0005	Los Angeles	California
United States	Amphastar Site 0025	Medford	Oregon
United States	Amphastar Site 0014	Minneapolis	Minnesota
United States	Amphastar Site 0030	New Braunfels	Texas
United States	Amphastar Site 0029	North Charleston	South Carolina
United States	Amphastar Site 0013	North Dartmouth	Massachusetts
United States	Amphastar Site 0004	Orange	California
United States	Amphastar Site 0015	Plymouth	Minnesota
United States	Amphastar Site 0026	Portland	Oregon
United States	Amphastar Site 0018	Raleigh	North Carolina
United States	Amphastar Site 0033	Richmond	Virginia
United States	Amphastar Site 0001	San Jose	California
United States	Amphastar Site 0034	Seattle	Washington
United States	Amphastar Site 0020	Skillman	New Jersey
United States	Amphastar Site 0016	St. Louis	Missouri
United States	Amphastar Site 0003	Stockton	California
United States	Amphastar Site 0009	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Amphastar Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

Hankinson 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Recording of all adverse events experienced during the course of the study	up to 12 weeks
Secondary	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.	Study visit 4, 8 and 12, greater than one hour after last dose
Secondary	Asthma Exacerbations	Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication.	up to 12 weeks