Synergistic combination comprising roflumilast and formoterol

A method of preventing the symptoms of, or treating a respiratory tract disorder in a human comprising administering to a human in need thereof a therapeutically effective amount of roflumilast, or a hydrate, solvate, salt, hydrate of a salt, solvate of a salt or N-oxide thereof in a daily dosage of from 100 to 500 μg and formoterol or a hydrate, solvate, salt, hydrate of a salt or solvate of a salt thereof in a daily dosage of from 10 to 120 μg.

A pharmaceutical composition comprising roflumilast or a hydrate, solvate, salt, hydrate of a salt, solvate of a salt or N-oxide thereof, formoterol or a hydrate, solvate, salt, hydrate of a salt or solvate of a salt thereof, and a pharmaceutically acceptable excipient in fixed or free combination.

A method for preventing or reducing the onset of symptoms of a pulmonary disease, or treating or reducing the severity of a pulmonary disease by administering to a patient in need thereof an effective amount of roflumilast or a hydrate, solvate, salt, hydrate of a salt, solvate of a salt or N-oxide thereof and formoterol or a hydrate, solvate, salt, hydrate of a salt or solvate of a salt thereof either in a single combined form, separately, or separately and sequentially where the sequential administration is close in time, or remote in time.

A medicament pack, containing roflumilast or a hydrate, solvate, salt, hydrate of a salt, solvate of a salt or N-oxide thereof as active ingredient, which contains a description that roflumilast or a hydrate, solvate, salt, hydrate of a salt, solvate of a salt or N-oxide thereof can be administered, for reducing the onset of symptoms of a pulmonary disease, or for treating or reducing the severity of a pulmonary disease, together with formoterol or a hydrate, solvate, salt, hydrate of a salt or solvate of a salt thereof sequentially, where the sequential administration is close in time, or remote in time in any order whatever.

A medicament pack, containing formoterol or a hydrate, solvate, salt, hydrate of a salt or solvate of a salt thereof as active ingredient, which contains a description that formoterol or a hydrate, solvate, salt, hydrate of a salt or solvate of a salt thereof can be administered, for reducing the onset of symptoms of a pulmonary disease, or for treating or reducing the severity of a pulmonary disease, together with roflumilast or a hydrate, solvate, salt, hydrate of a salt, solvate of a salt or N-oxide thereof sequentially, where the sequential administration is close in time, or remote in time in any order whatever.