Clinical trial NCT00685022 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: levalbuterol hfa mdi followed by racemic albuterol hfa mdi, racemic albuterol followed by levalbuterol hfa mdi
SMILES: [H][C@]12CC[C@]([H])(C[C@@H](C1)OC(=O)C(CO)C1=CC=CC=C1)[N+]2(C)C(C)C, CC(C)(C)NCC(O)C1=CC(CO)=C(O)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Subject, male or female, must be at least 12 years of age at the time of consent.

          -  Female subjects 12-60 years of age inclusive must have a negative serum pregnancy test
             at study start.

          -  Women of child bearing potential must be using an acceptable method of birth control
             throughout the study.

          -  Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to
             study start.

          -  Subject must be in good health with the exception of their reversible airways disease
             and not suffering from any chronic condition that might affect their respiratory
             function.

          -  Subject must have a chest X-ray or had one within 12 months prior to randomization.

          -  Subject must be able to complete the diary cards and medical event calendars reliably
             on a daily basis, understand dosing instructions and be able to demonstrate good MDI
             administration technique. Any minor subject who is not able to do this must have a
             parent/legal guardian who can assist them during the study with these activities.

        Exclusion Criteria:

          -  Female subject who is pregnant or lactating.

          -  Subject who has participated in an investigational drug study within 30 days prior to
             study start, or who is currently participating in another clinical trial.

          -  Subject whose schedule prevents him or her from starting study visits before 9 AM.

          -  Subject who has travel commitments during the study that would interfere with trial
             measurements or compliance or both.

          -  Subject who has a history of hospitalization for asthma within 4 weeks prior to study
             start, or who is scheduled for in-patient hospitalization, including elective surgery
             during the course of the trial

          -  Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the
             excipients contained in any of these formulations.

          -  Subject using any prescription drug with which albuterol sulfate administration is
             contraindicated.

          -  Subject with currently diagnosed life-threatening asthma defined as a history of
             asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest,
             or hypoxic seizures within 12 months prior to study start.

          -  Subject with a history of cancer (exception: basal cell carcinoma in remission).

          -  Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure
             disorders.

          -  Subject with a history of substance abuse or drug abuse within 12 months preceding
             study start.

          -  Subject with greater than 10 pack year history of cigarette smoking or use of any
             tobacco products within 6 months of study start.

          -  Subject with a documented history of bronchopulmonary aspergillosis or any form of
             allergic alveolitis.

          -  Subject who has suffered from a clinically significant upper or lower respiratory
             tract infection in the 3 weeks prior to study start.

          -  Subject with unstable asthma; or who have had a change in asthma therapy; or a visit
             to the Emergency Department or hospital for worsening asthma within 4 weeks.

          -  Subject who is a staff member or relative of a staff member.