Clinical trial NCT00119496 (phase 2/phase 3, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: rosiglitazone, theophylline, beclomethasone, inhaled beclomethasone and oral theophylline
SMILES: CCN1C=C(C(O)=O)C(=O)C2=C1C=C(C=C2)C1=CC=NC=C1, CN1C2=C(NC=N2)C(=O)N(C)C1=O, [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  Males or females between 18 and 60 years of age (inclusive).

          -  Clinical diagnosis of mild or moderate persistent asthma in accordance with the Global
             Initiative for Asthma (GINA) criteria

          -  Have had a history of asthma for a minimum of 6 months prior to entry into the study

          -  Subjects must be current cigarette smokers with a minimum five-pack-year smoking
             history

          -  Baseline FEV1 that is greater than 50% predicted; and reversibility of 12% or more at
             screening, washout or randomisation.

          -  Capable of providing signed written informed consent and complying with all the
             specified study procedures.

        Exclusion Criteria:

          -  Asthma exacerbation or a respiratory tract infection within four weeks of screening.

          -  Type 1 or type 2 diabetes mellitus.

          -  Women who are lactating, pregnant, or planning to become pregnant.

          -  Clinically significant renal or hepatic laboratory values (e.g. AST/ALT/total
             bilirubin/AP > 2.5 times normal values).

          -  Anaemia (< 11 g/dL for males or < 10 g/dL for females)

          -  Contraindications to treatment as outlined in any of the product labels

          -  Prior history of severe oedema or serious fluid related event (e.g., heart failure)
             associated with any TZD

          -  The subject has a history of significant hypersensitivity to study drugs

          -  Presence of unstable or severe angina or congestive heart failure (NYHA class III/IV)
             or evidence or history of known congestive heart failure (NYHA class I-IV) or an
             abnormal electrocardiogram (ECG), as determined by the Investigator, or subjects who
             have had new cardiac events (such as MI, new CHF, PTCA, CABG) within 6 months of
             screening.

          -  History or suspicion of current drug abuse or alcohol abuse within the last 6 months.

          -  History suggestive of active infection or non-asthma lung pathology

          -  Clinically significant renal disease, metabolic syndrome, cirrhosis (Child-Pugh Class
             B/C), hypertension or any other clinically significant cardiovascular, neurological,
             endocrine, or haematological abnormalities that are uncontrolled on permitted therapy.

          -  Risk factors for human immunodeficiency virus (HIV), hepatitis B or hepatitis C
             infection at Screening (Visit 1)

          -  Subjects who are morbidly obese, defined as having a body mass index (BMI) > 40 kg/m2

          -  Unable to perform spirometry

          -  Subjects who require treatment with any of the following asthma medications from
             Screening (Visit 1) until study completion:

               -  Inhaled cromolyn sodium or nedocromil;

               -  Ipratropium bromide;

               -  Xanthines (theophylline preparations);

               -  Leukotriene modifiers;

               -  Long-acting inhaled beta2-agonists (salmeterol, formoterol);

               -  Oral beta2-agonists.

          -  Treatment with oral, intravenous or intra-articular corticosteroids within 6 weeks of
             Screening or thereafter.

          -  Subjects who have been taking in excess of 1000 μg daily of beclomethasone (or
             equivalent) within 6 weeks of Screening